Trial Outcomes & Findings for Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System (NCT NCT01777295)
NCT ID: NCT01777295
Last Updated: 2019-01-04
Results Overview
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
81 participants
Primary outcome timeframe
At Day -30 prior to placebo administration
Results posted on
2019-01-04
Participant Flow
Participant milestones
| Measure |
HBsAg/AS_1+2 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Overall Study
STARTED
|
40
|
41
|
|
Overall Study
COMPLETED
|
36
|
38
|
|
Overall Study
NOT COMPLETED
|
4
|
3
|
Reasons for withdrawal
| Measure |
HBsAg/AS_1+2 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; or during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; or during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
2
|
|
Overall Study
Pregnancy
|
0
|
1
|
|
Overall Study
Personal problem
|
1
|
0
|
|
Overall Study
Investigator call for AEs check
|
1
|
0
|
Baseline Characteristics
Development of Read-outs in Healthy, Hepatitis B Virus Naive Adults Vaccinated With the Hepatitis B Surface Antigen (HBsAg) in Combination With a GlaxoSmithKline (GSK) Biologicals' Adjuvant System
Baseline characteristics by cohort
| Measure |
HBsAg/AS_1+2 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
n=41 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Total
n=81 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
39.2 Years
STANDARD_DEVIATION 4.1 • n=99 Participants
|
37.5 Years
STANDARD_DEVIATION 5.9 • n=107 Participants
|
38.4 Years
STANDARD_DEVIATION 5.2 • n=206 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=99 Participants
|
26 Participants
n=107 Participants
|
51 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
15 Participants
n=99 Participants
|
15 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · African Heritage / African American
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Arabic / North African Heritage
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race/Ethnicity, Customized
Geographic ancestry · White - Caucasian / European Heritage
|
38 Participants
n=99 Participants
|
39 Participants
n=107 Participants
|
77 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: At Day -30 prior to placebo administrationPopulation: Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines - Step 1
E-selectin
|
6250 pg/mL
Interval 4600.0 to 7800.0
|
6000 pg/mL
Interval 4600.0 to 8300.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.1
|
3.3 pg/mL
Interval 3.3 to 4.5
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-18
|
177 pg/mL
Interval 152.0 to 215.0
|
198 pg/mL
Interval 148.0 to 290.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 7.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-6r
|
22500 pg/mL
Interval 22000.0 to 30000.0
|
26000 pg/mL
Interval 20000.0 to 30000.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines - Step 1
IL-8
|
5.1 pg/mL
Interval 3.9 to 5.9
|
5.7 pg/mL
Interval 4.2 to 6.6
|
|
Concentrations of Cytokines and Chemokines - Step 1
IP-10
|
247.5 pg/mL
Interval 195.0 to 280.0
|
225 pg/mL
Interval 176.0 to 402.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MCP-1
|
98.5 pg/mL
Interval 83.0 to 117.0
|
107 pg/mL
Interval 89.0 to 142.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MCP-2
|
19.5 pg/mL
Interval 17.0 to 26.0
|
18 pg/mL
Interval 13.0 to 25.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MCP-4
|
1170 pg/mL
Interval 1100.0 to 1600.0
|
1230 pg/mL
Interval 1070.0 to 1550.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MIG
|
435 pg/mL
Interval 285.0 to 674.0
|
513 pg/mL
Interval 354.0 to 682.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MIP-1 alpha
|
20 pg/mL
Interval 18.0 to 24.0
|
20 pg/mL
Interval 18.0 to 25.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MIP-1 beta
|
138 pg/mL
Interval 126.0 to 205.0
|
190 pg/mL
Interval 162.0 to 228.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MIP-3 alpha
|
18 pg/mL
Interval 11.0 to 28.0
|
25 pg/mL
Interval 11.0 to 32.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
MPIF-1
|
1450 pg/mL
Interval 1200.0 to 1600.0
|
1600 pg/mL
Interval 1200.0 to 1800.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 1.5 HoursPopulation: Analyses were performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations - Step 1
E-selectin
|
6450 pg/mL
Interval 4500.0 to 7600.0
|
5900 pg/mL
Interval 4100.0 to 8500.0
|
|
Cytokines and Chemokines Concentrations - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.7
|
3.3 pg/mL
Interval 3.3 to 3.7
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-18
|
179.5 pg/mL
Interval 136.0 to 215.0
|
172 pg/mL
Interval 141.0 to 225.0
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.3
|
5.9 pg/mL
Interval 5.9 to 7.0
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-6r
|
22000 pg/mL
Interval 19000.0 to 29000.0
|
26000 pg/mL
Interval 21000.0 to 30000.0
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations - Step 1
IL-8
|
4.2 pg/mL
Interval 3.2 to 5.3
|
4.2 pg/mL
Interval 3.7 to 4.9
|
|
Cytokines and Chemokines Concentrations - Step 1
IP-10
|
207 pg/mL
Interval 172.0 to 240.0
|
220 pg/mL
Interval 183.0 to 330.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MCP-1
|
77.5 pg/mL
Interval 63.0 to 96.0
|
79 pg/mL
Interval 58.0 to 101.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MCP-2
|
19 pg/mL
Interval 14.0 to 25.0
|
17 pg/mL
Interval 13.0 to 24.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MCP-4
|
1190 pg/mL
Interval 896.0 to 1300.0
|
1300 pg/mL
Interval 933.0 to 1480.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MIG
|
336 pg/mL
Interval 269.0 to 487.0
|
392 pg/mL
Interval 344.0 to 575.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MIP-1 beta
|
124.5 pg/mL
Interval 107.0 to 151.0
|
141 pg/mL
Interval 108.0 to 191.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MIP-3 alpha
|
16 pg/mL
Interval 13.0 to 22.0
|
16 pg/mL
Interval 13.0 to 27.0
|
|
Cytokines and Chemokines Concentrations - Step 1
MPIF-1
|
1400 pg/mL
Interval 1000.0 to 1600.0
|
1500 pg/mL
Interval 1200.0 to 1600.0
|
|
Cytokines and Chemokines Concentrations - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 3 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines in Step 1
E-selectin
|
6300 pg/mL
Interval 4100.0 to 7600.0
|
5600 pg/mL
Interval 3800.0 to 7800.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.4
|
3.3 pg/mL
Interval 3.3 to 4.2
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-18
|
173 pg/mL
Interval 142.0 to 202.0
|
168 pg/mL
Interval 154.0 to 283.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 7.4
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-6r
|
26000 pg/mL
Interval 21000.0 to 33000.0
|
28000 pg/mL
Interval 22000.0 to 34000.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines in Step 1
IL-8
|
4 pg/mL
Interval 3.2 to 5.3
|
4.2 pg/mL
Interval 3.5 to 6.4
|
|
Concentrations of Cytokines and Chemokines in Step 1
IP-10
|
217.5 pg/mL
Interval 175.0 to 251.0
|
223 pg/mL
Interval 169.0 to 396.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MCP-1
|
64 pg/mL
Interval 48.0 to 104.0
|
79 pg/mL
Interval 65.0 to 92.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MCP-2
|
20 pg/mL
Interval 18.0 to 23.0
|
21 pg/mL
Interval 14.0 to 27.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MCP-4
|
1175 pg/mL
Interval 1060.0 to 1310.0
|
1170 pg/mL
Interval 951.0 to 1440.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MIG
|
343 pg/mL
Interval 285.0 to 504.0
|
439 pg/mL
Interval 347.0 to 558.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MIP-1 beta
|
127 pg/mL
Interval 112.0 to 147.0
|
163 pg/mL
Interval 120.0 to 199.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MIP-3 alpha
|
18 pg/mL
Interval 14.0 to 22.0
|
18 pg/mL
Interval 12.0 to 27.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
MPIF-1
|
1300 pg/mL
Interval 1000.0 to 1500.0
|
1600 pg/mL
Interval 1200.0 to 1900.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 6 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines During Step 1
E-selectin
|
6050 pg/mL
Interval 4200.0 to 8100.0
|
5200 pg/mL
Interval 3900.0 to 8300.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.6
|
3.3 pg/mL
Interval 3.3 to 4.6
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-18
|
177.5 pg/mL
Interval 132.0 to 233.0
|
176 pg/mL
Interval 160.0 to 273.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.0
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 2.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-6r
|
24500 pg/mL
Interval 20000.0 to 33000.0
|
27000 pg/mL
Interval 21000.0 to 32000.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines During Step 1
IL-8
|
4.5 pg/mL
Interval 3.9 to 5.8
|
4.5 pg/mL
Interval 3.7 to 6.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
IP-10
|
218 pg/mL
Interval 174.0 to 252.0
|
217 pg/mL
Interval 177.0 to 400.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MCP-1
|
101 pg/mL
Interval 76.0 to 129.0
|
104 pg/mL
Interval 76.0 to 119.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MCP-2
|
20.5 pg/mL
Interval 16.0 to 23.0
|
18 pg/mL
Interval 14.0 to 24.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MCP-4
|
1245 pg/mL
Interval 1110.0 to 1490.0
|
1310 pg/mL
Interval 1030.0 to 1570.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MIG
|
378 pg/mL
Interval 313.0 to 566.0
|
500 pg/mL
Interval 320.0 to 614.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MIP-1 beta
|
146 pg/mL
Interval 129.0 to 180.0
|
166 pg/mL
Interval 140.0 to 215.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MIP-3 alpha
|
20 pg/mL
Interval 15.0 to 24.0
|
21 pg/mL
Interval 15.0 to 26.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
MPIF-1
|
1400 pg/mL
Interval 1100.0 to 1700.0
|
1500 pg/mL
Interval 1200.0 to 1800.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 9 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines - Step 1
E-selectin
|
6100 pg/mL
Interval 4600.0 to 7500.0
|
5300 pg/mL
Interval 3600.0 to 7100.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 4.8
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-18
|
167.5 pg/mL
Interval 117.0 to 202.0
|
173 pg/mL
Interval 139.0 to 226.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.2
|
5.9 pg/mL
Interval 5.9 to 14.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 2.7
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-6r
|
26000 pg/mL
Interval 19000.0 to 29000.0
|
24000 pg/mL
Interval 19000.0 to 31000.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines/Chemokines - Step 1
IL-8
|
4.5 pg/mL
Interval 3.6 to 5.3
|
4.9 pg/mL
Interval 3.7 to 6.9
|
|
Concentrations of Cytokines/Chemokines - Step 1
IP-10
|
205.5 pg/mL
Interval 159.0 to 227.0
|
210 pg/mL
Interval 162.0 to 327.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MCP-1
|
81 pg/mL
Interval 61.0 to 109.0
|
86 pg/mL
Interval 65.0 to 104.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MCP-2
|
17 pg/mL
Interval 15.0 to 21.0
|
17 pg/mL
Interval 15.0 to 24.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MCP-4
|
1145 pg/mL
Interval 944.0 to 1400.0
|
1310 pg/mL
Interval 1050.0 to 1610.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MIG
|
327 pg/mL
Interval 244.0 to 528.0
|
452 pg/mL
Interval 313.0 to 610.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 22.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MIP-1 beta
|
119.5 pg/mL
Interval 102.0 to 134.0
|
131 pg/mL
Interval 111.0 to 185.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MIP-3 alpha
|
15 pg/mL
Interval 11.0 to 17.0
|
19 pg/mL
Interval 11.0 to 25.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
MPIF-1
|
1200 pg/mL
Interval 1000.0 to 1400.0
|
1400 pg/mL
Interval 1100.0 to 1800.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 12 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
E-selectin
|
5600 pg/mL
Interval 4000.0 to 7800.0
|
5200 pg/mL
Interval 3500.0 to 7900.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-18
|
180 pg/mL
Interval 131.0 to 222.0
|
171 pg/mL
Interval 150.0 to 244.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.3
|
5.9 pg/mL
Interval 5.9 to 6.3
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-6r
|
24000 pg/mL
Interval 21000.0 to 34000.0
|
26000 pg/mL
Interval 21000.0 to 32000.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines/Chemokines in Step 1
IL-8
|
4.5 pg/mL
Interval 3.9 to 5.8
|
4.6 pg/mL
Interval 3.9 to 5.9
|
|
Concentrations of Cytokines/Chemokines in Step 1
IP-10
|
214 pg/mL
Interval 182.0 to 246.0
|
217 pg/mL
Interval 160.0 to 335.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MCP-1
|
120 pg/mL
Interval 96.0 to 137.0
|
117 pg/mL
Interval 79.0 to 133.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MCP-2
|
19 pg/mL
Interval 17.0 to 25.0
|
18 pg/mL
Interval 14.0 to 26.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MCP-4
|
1160 pg/mL
Interval 997.0 to 1480.0
|
1260 pg/mL
Interval 1000.0 to 1480.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MIG
|
412 pg/mL
Interval 341.0 to 564.0
|
460 pg/mL
Interval 344.0 to 623.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MIP-1 beta
|
137 pg/mL
Interval 118.0 to 167.0
|
159 pg/mL
Interval 120.0 to 179.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MIP-3 alpha
|
22 pg/mL
Interval 17.0 to 28.0
|
21 pg/mL
Interval 14.0 to 26.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
MPIF-1
|
1300 pg/mL
Interval 1000.0 to 1500.0
|
1400 pg/mL
Interval 1200.0 to 1700.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -30 plus 18 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=14 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines During Step 1
MPIF-1
|
1100 pg/mL
Interval 920.0 to 1500.0
|
1400 pg/mL
Interval 1300.0 to 1700.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
E-selectin
|
4200 pg/mL
Interval 2700.0 to 6300.0
|
4950 pg/mL
Interval 2900.0 to 6500.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.6
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-18
|
142 pg/mL
Interval 81.0 to 182.0
|
174 pg/mL
Interval 118.0 to 267.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.0
|
6 pg/mL
Interval 5.9 to 6.3
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 2.4
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-6r
|
21000 pg/mL
Interval 18000.0 to 28000.0
|
21500 pg/mL
Interval 18000.0 to 29000.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines/Chemokines During Step 1
IL-8
|
6.1 pg/mL
Interval 4.9 to 7.8
|
5.5 pg/mL
Interval 4.6 to 8.2
|
|
Concentrations of Cytokines/Chemokines During Step 1
IP-10
|
238 pg/mL
Interval 170.0 to 483.0
|
243.5 pg/mL
Interval 174.0 to 386.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MCP-1
|
109 pg/mL
Interval 79.0 to 132.0
|
98 pg/mL
Interval 76.0 to 119.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MCP-2
|
17 pg/mL
Interval 16.0 to 27.0
|
18 pg/mL
Interval 12.0 to 26.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MCP-4
|
1390 pg/mL
Interval 1140.0 to 1710.0
|
1445 pg/mL
Interval 1130.0 to 1640.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MIG
|
458 pg/mL
Interval 340.0 to 811.0
|
420 pg/mL
Interval 373.0 to 636.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 23.0
|
18 pg/mL
Interval 18.0 to 26.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MIP-1 beta
|
165 pg/mL
Interval 128.0 to 216.0
|
143.5 pg/mL
Interval 136.0 to 182.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
MIP-3 alpha
|
20 pg/mL
Interval 17.0 to 38.0
|
30 pg/mL
Interval 21.0 to 34.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -29Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines and Chemokines Concentrations in Step 1
E-selectin
|
6350 pg/mL
Interval 4500.0 to 8600.0
|
5900 pg/mL
Interval 4300.0 to 8500.0
|
|
Cytokines and Chemokines Concentrations in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 4.5
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-18
|
177.5 pg/mL
Interval 136.0 to 242.0
|
186 pg/mL
Interval 149.0 to 261.0
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.7
|
1.6 pg/mL
Interval 1.6 to 1.7
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-6r
|
26500 pg/mL
Interval 19000.0 to 31000.0
|
27000 pg/mL
Interval 19000.0 to 35000.0
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations in Step 1
IL-8
|
5.2 pg/mL
Interval 4.3 to 6.8
|
5.4 pg/mL
Interval 3.9 to 6.9
|
|
Cytokines and Chemokines Concentrations in Step 1
IP-10
|
244.5 pg/mL
Interval 200.0 to 307.0
|
241 pg/mL
Interval 190.0 to 345.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MCP-1
|
81.5 pg/mL
Interval 66.0 to 104.0
|
93 pg/mL
Interval 73.0 to 116.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MCP-2
|
19 pg/mL
Interval 16.0 to 25.0
|
19 pg/mL
Interval 15.0 to 24.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MCP-4
|
1170 pg/mL
Interval 1020.0 to 1450.0
|
1230 pg/mL
Interval 1070.0 to 1350.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MIG
|
418.5 pg/mL
Interval 352.0 to 721.0
|
528 pg/mL
Interval 327.0 to 695.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
19 pg/mL
Interval 18.0 to 24.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MIP-1 beta
|
141.5 pg/mL
Interval 123.0 to 188.0
|
169 pg/mL
Interval 124.0 to 219.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MIP-3 alpha
|
21 pg/mL
Interval 14.0 to 28.0
|
22 pg/mL
Interval 17.0 to 28.0
|
|
Cytokines and Chemokines Concentrations in Step 1
MPIF-1
|
1500 pg/mL
Interval 1100.0 to 1700.0
|
1700 pg/mL
Interval 1200.0 to 1900.0
|
|
Cytokines and Chemokines Concentrations in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -28Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concetrations During Step 1
E-selectin
|
6250 pg/mL
Interval 4300.0 to 7900.0
|
5900 pg/mL
Interval 3700.0 to 7800.0
|
|
Cytokines and Chemokines Concetrations During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concetrations During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.9
|
3.3 pg/mL
Interval 3.3 to 3.9
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-18
|
178.5 pg/mL
Interval 120.0 to 232.0
|
182 pg/mL
Interval 148.0 to 288.0
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-6r
|
25500 pg/mL
Interval 20000.0 to 28000.0
|
27000 pg/mL
Interval 20000.0 to 35000.0
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concetrations During Step 1
IL-8
|
4.9 pg/mL
Interval 3.5 to 6.6
|
4.8 pg/mL
Interval 3.7 to 6.5
|
|
Cytokines and Chemokines Concetrations During Step 1
IP-10
|
228 pg/mL
Interval 186.0 to 304.0
|
270 pg/mL
Interval 205.0 to 381.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MCP-1
|
73.5 pg/mL
Interval 47.0 to 90.0
|
74 pg/mL
Interval 56.0 to 112.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MCP-2
|
18.5 pg/mL
Interval 15.0 to 26.0
|
19 pg/mL
Interval 13.0 to 26.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MCP-4
|
1140 pg/mL
Interval 951.0 to 1340.0
|
1200 pg/mL
Interval 937.0 to 1530.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MIG
|
397 pg/mL
Interval 292.0 to 587.0
|
468 pg/mL
Interval 336.0 to 568.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MIP-1 beta
|
151.5 pg/mL
Interval 113.0 to 175.0
|
174 pg/mL
Interval 141.0 to 227.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MIP-3 alpha
|
17.5 pg/mL
Interval 11.0 to 33.0
|
20 pg/mL
Interval 15.0 to 28.0
|
|
Cytokines and Chemokines Concetrations During Step 1
MPIF-1
|
1350 pg/mL
Interval 970.0 to 1600.0
|
1500 pg/mL
Interval 1200.0 to 1800.0
|
|
Cytokines and Chemokines Concetrations During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concetrations During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -27Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines/Chemokines Concentrations in Step 1
E-selectin
|
6250 pg/mL
Interval 4000.0 to 7200.0
|
6150 pg/mL
Interval 3700.0 to 8200.0
|
|
Cytokines/Chemokines Concentrations in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines/Chemokines Concentrations in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.2
|
3.4 pg/mL
Interval 3.3 to 4.5
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-18
|
174.5 pg/mL
Interval 139.0 to 217.0
|
183 pg/mL
Interval 157.0 to 236.0
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.7
|
1.6 pg/mL
Interval 1.6 to 1.7
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-6r
|
24000 pg/mL
Interval 21000.0 to 29000.0
|
26000 pg/mL
Interval 21000.0 to 32000.0
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines/Chemokines Concentrations in Step 1
IL-8
|
4.2 pg/mL
Interval 3.6 to 5.4
|
4.3 pg/mL
Interval 3.4 to 6.6
|
|
Cytokines/Chemokines Concentrations in Step 1
IP-10
|
220.5 pg/mL
Interval 186.0 to 281.0
|
239 pg/mL
Interval 189.0 to 348.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MCP-1
|
86.5 pg/mL
Interval 73.0 to 109.0
|
84.5 pg/mL
Interval 65.0 to 110.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MCP-2
|
20 pg/mL
Interval 15.0 to 25.0
|
18.5 pg/mL
Interval 14.0 to 22.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MCP-4
|
1060 pg/mL
Interval 911.0 to 1360.0
|
1150 pg/mL
Interval 989.0 to 1270.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MIG
|
403.5 pg/mL
Interval 300.0 to 635.0
|
429.5 pg/mL
Interval 349.0 to 542.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 23.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MIP-1 beta
|
141 pg/mL
Interval 106.0 to 181.0
|
165 pg/mL
Interval 117.0 to 196.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MIP-3 alpha
|
21 pg/mL
Interval 18.0 to 26.0
|
20.5 pg/mL
Interval 18.0 to 27.0
|
|
Cytokines/Chemokines Concentrations in Step 1
MPIF-1
|
1300 pg/mL
Interval 1100.0 to 1600.0
|
1350 pg/mL
Interval 1200.0 to 1700.0
|
|
Cytokines/Chemokines Concentrations in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines/Chemokines Concentrations in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-placebo at Day -23Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.5
|
3.3 pg/mL
Interval 3.3 to 4.3
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-18
|
176.5 pg/mL
Interval 122.0 to 208.0
|
184 pg/mL
Interval 150.0 to 247.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-6r
|
23500 pg/mL
Interval 19000.0 to 28000.0
|
27000 pg/mL
Interval 17000.0 to 310000.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-8
|
5 pg/mL
Interval 3.5 to 5.8
|
4.5 pg/mL
Interval 3.9 to 6.8
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.0
|
5.9 pg/mL
Interval 5.9 to 7.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IP-10
|
223 pg/mL
Interval 186.0 to 285.0
|
241 pg/mL
Interval 190.0 to 366.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1
E-selectin
|
6150 pg/mL
Interval 4700.0 to 7900.0
|
5500 pg/mL
Interval 4000.0 to 8300.0
|
|
Cytokines and Chemokines Concentrations During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1
MCP-1
|
72 pg/mL
Interval 66.0 to 96.0
|
88 pg/mL
Interval 55.0 to 143.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MCP-2
|
19 pg/mL
Interval 16.0 to 23.0
|
15 pg/mL
Interval 14.0 to 25.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MCP-4
|
1145 pg/mL
Interval 1000.0 to 1350.0
|
1390 pg/mL
Interval 1000.0 to 1480.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MIG
|
375.5 pg/mL
Interval 286.0 to 625.0
|
391 pg/mL
Interval 337.0 to 524.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 22.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MIP-1 beta
|
138.5 pg/mL
Interval 113.0 to 158.0
|
165 pg/mL
Interval 128.0 to 199.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MIP-3 alpha
|
16 pg/mL
Interval 10.0 to 21.0
|
21 pg/mL
Interval 13.0 to 28.0
|
|
Cytokines and Chemokines Concentrations During Step 1
MPIF-1
|
1350 pg/mL
Interval 1000.0 to 1700.0
|
1600 pg/mL
Interval 1200.0 to 1800.0
|
|
Cytokines and Chemokines Concentrations During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Pre-dose1 at Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines - Study Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-6r
|
24500 pg/mL
Interval 22000.0 to 29000.0
|
27000 pg/mL
Interval 20000.0 to 32000.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-8
|
5 pg/mL
Interval 4.2 to 7.4
|
4.9 pg/mL
Interval 4.2 to 6.2
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IP-10
|
225 pg/mL
Interval 178.0 to 334.0
|
243 pg/mL
Interval 199.0 to 294.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MCP-1
|
92.5 pg/mL
Interval 80.0 to 125.0
|
94 pg/mL
Interval 75.0 to 121.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MCP-2
|
19 pg/mL
Interval 16.0 to 28.0
|
18 pg/mL
Interval 14.0 to 22.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MCP-4
|
1260 pg/mL
Interval 1030.0 to 1520.0
|
1310 pg/mL
Interval 1110.0 to 1570.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MIG
|
462.5 pg/mL
Interval 303.0 to 701.0
|
496 pg/mL
Interval 328.0 to 705.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 23.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MIP-1 beta
|
153 pg/mL
Interval 124.0 to 196.0
|
164 pg/mL
Interval 121.0 to 198.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MIP-3 alpha
|
19.5 pg/mL
Interval 14.0 to 24.0
|
20 pg/mL
Interval 11.0 to 27.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
MPIF-1
|
1300 pg/mL
Interval 1000.0 to 1500.0
|
1500 pg/mL
Interval 1300.0 to 1700.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
E-selectin
|
6150 pg/mL
Interval 5000.0 to 8600.0
|
6100 pg/mL
Interval 4200.0 to 9000.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.9
|
3.3 pg/mL
Interval 3.3 to 3.5
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-18
|
171 pg/mL
Interval 119.0 to 207.0
|
169 pg/mL
Interval 151.0 to 237.0
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.5
|
5.9 pg/mL
Interval 5.9 to 6.5
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines - Study Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 0 plus 1.5 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
E-selectin
|
5900 pg/mL
Interval 4800.0 to 8100.0
|
5500 pg/mL
Interval 4000.0 to 8400.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.9
|
3.3 pg/mL
Interval 3.3 to 3.8
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-18
|
168 pg/mL
Interval 126.0 to 208.0
|
168 pg/mL
Interval 144.0 to 220.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.4
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-6r
|
25000 pg/mL
Interval 19000.0 to 29000.0
|
26000 pg/mL
Interval 21000.0 to 32000.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-8
|
4.2 pg/mL
Interval 3.3 to 5.1
|
4.9 pg/mL
Interval 3.6 to 5.5
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
IP-10
|
226 pg/mL
Interval 186.0 to 265.0
|
224 pg/mL
Interval 198.0 to 318.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-1
|
75 pg/mL
Interval 56.0 to 108.0
|
74 pg/mL
Interval 56.0 to 97.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-2
|
20 pg/mL
Interval 16.0 to 22.0
|
18 pg/mL
Interval 14.0 to 23.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MIG
|
378 pg/mL
Interval 308.0 to 522.0
|
423 pg/mL
Interval 385.0 to 535.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-4
|
1240 pg/mL
Interval 951.0 to 1340.0
|
1240 pg/mL
Interval 943.0 to 1520.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 22.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-1 beta
|
137 pg/mL
Interval 114.0 to 167.0
|
164 pg/mL
Interval 132.0 to 194.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-3 alpha
|
20 pg/mL
Interval 14.0 to 24.0
|
18 pg/mL
Interval 15.0 to 26.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
MPIF-1
|
1200 pg/mL
Interval 970.0 to 1400.0
|
1500 pg/mL
Interval 1300.0 to 1800.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 0 plus 6 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
E-selectin
|
5900 pg/mL
Interval 4300.0 to 7600.0
|
5400 pg/mL
Interval 4100.0 to 7600.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-18
|
169 pg/mL
Interval 110.0 to 220.0
|
170 pg/mL
Interval 130.0 to 225.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.0
|
5.9 pg/mL
Interval 5.9 to 6.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.7
|
3.4 pg/mL
Interval 2.4 to 6.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-6r
|
25000 pg/mL
Interval 22000.0 to 30000.0
|
26000 pg/mL
Interval 20000.0 to 33000.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-8
|
4.6 pg/mL
Interval 3.9 to 7.2
|
4.6 pg/mL
Interval 3.9 to 5.5
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
IP-10
|
204 pg/mL
Interval 180.0 to 282.0
|
207 pg/mL
Interval 179.0 to 270.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-1
|
85 pg/mL
Interval 66.0 to 112.0
|
94 pg/mL
Interval 75.0 to 123.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-2
|
18.5 pg/mL
Interval 16.0 to 23.0
|
18 pg/mL
Interval 15.0 to 20.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-4
|
1130 pg/mL
Interval 989.0 to 1310.0
|
1130 pg/mL
Interval 912.0 to 1390.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MIG
|
372.5 pg/mL
Interval 302.0 to 557.0
|
459 pg/mL
Interval 332.0 to 567.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-1 beta
|
141 pg/mL
Interval 111.0 to 174.0
|
165 pg/mL
Interval 129.0 to 181.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-3 alpha
|
18.5 pg/mL
Interval 12.0 to 23.0
|
19 pg/mL
Interval 15.0 to 28.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
MPIF-1
|
1300 pg/mL
Interval 1000.0 to 1500.0
|
1400 pg/mL
Interval 1200.0 to 1600.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 0 plus 12 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations - Study Step 1
MCP-2
|
19.5 pg/mL
Interval 15.0 to 25.0
|
19 pg/mL
Interval 15.0 to 27.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MIG
|
410 pg/mL
Interval 296.0 to 588.0
|
478 pg/mL
Interval 361.0 to 614.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MIP-1 beta
|
132 pg/mL
Interval 102.0 to 171.0
|
183 pg/mL
Interval 142.0 to 212.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MIP-3 alpha
|
19.5 pg/mL
Interval 14.0 to 27.0
|
20 pg/mL
Interval 17.0 to 28.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
E-selectin
|
6400 pg/mL
Interval 5000.0 to 8000.0
|
5900 pg/mL
Interval 4400.0 to 8800.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.9 pg/mL
Interval 3.3 to 5.5
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-18
|
181.5 pg/mL
Interval 128.0 to 205.0
|
171 pg/mL
Interval 155.0 to 235.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.0
|
5.9 pg/mL
Interval 5.9 to 6.5
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
6.3 pg/mL
Interval 3.9 to 8.2
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-6r
|
24000 pg/mL
Interval 22000.0 to 33000.0
|
26000 pg/mL
Interval 21000.0 to 32000.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IL-8
|
4.8 pg/mL
Interval 4.0 to 5.6
|
4.2 pg/mL
Interval 3.5 to 5.1
|
|
Cytokines and Chemokines Concentrations - Study Step 1
IP-10
|
194 pg/mL
Interval 167.0 to 282.0
|
236 pg/mL
Interval 197.0 to 281.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MCP-1
|
111.5 pg/mL
Interval 84.0 to 129.0
|
111 pg/mL
Interval 87.0 to 137.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MCP-4
|
1265 pg/mL
Interval 1030.0 to 1520.0
|
1260 pg/mL
Interval 1000.0 to 1530.0
|
|
Cytokines and Chemokines Concentrations - Study Step 1
MPIF-1
|
1300 pg/mL
Interval 1000.0 to 1700.0
|
1600 pg/mL
Interval 1200.0 to 1700.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 0 plus 18 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=14 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.8 pg/mL
Interval 1.6 to 2.4
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
4.5 pg/mL
Interval 3.1 to 6.9
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MCP-4
|
1400 pg/mL
Interval 1220.0 to 1560.0
|
1400 pg/mL
Interval 1310.0 to 1650.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MIG
|
473 pg/mL
Interval 367.0 to 722.0
|
571 pg/mL
Interval 443.0 to 684.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 20.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MIP-1 beta
|
134 pg/mL
Interval 117.0 to 206.0
|
258 pg/mL
Interval 200.0 to 303.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MIP-3 alpha
|
20 pg/mL
Interval 17.0 to 30.0
|
35.5 pg/mL
Interval 24.0 to 45.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
E-selectin
|
4700 pg/mL
Interval 3500.0 to 5900.0
|
5750 pg/mL
Interval 3400.0 to 8000.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 4.8
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-18
|
126 pg/mL
Interval 93.0 to 168.0
|
180 pg/mL
Interval 155.0 to 217.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.0
|
5.9 pg/mL
Interval 5.9 to 6.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-6r
|
22000 pg/mL
Interval 19000.0 to 31000.0
|
22500 pg/mL
Interval 17000.0 to 26000.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IL-8
|
5.1 pg/mL
Interval 4.2 to 6.0
|
5.9 pg/mL
Interval 4.5 to 6.4
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
IP-10
|
228 pg/mL
Interval 184.0 to 258.0
|
319 pg/mL
Interval 268.0 to 477.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MCP-1
|
115 pg/mL
Interval 98.0 to 130.0
|
111 pg/mL
Interval 91.0 to 130.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MCP-2
|
20 pg/mL
Interval 17.0 to 22.0
|
29.5 pg/mL
Interval 19.0 to 34.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
MPIF-1
|
1400 pg/mL
Interval 1100.0 to 1600.0
|
1850 pg/mL
Interval 1500.0 to 2100.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MIP-1 beta
|
145 pg/mL
Interval 130.0 to 207.0
|
282.5 pg/mL
Interval 234.0 to 408.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.6
|
5.2 pg/mL
Interval 3.6 to 6.8
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-18
|
181 pg/mL
Interval 123.0 to 200.0
|
198.5 pg/mL
Interval 167.0 to 267.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
3 pg/mL
Interval 1.6 to 4.1
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IP-10
|
219 pg/mL
Interval 179.0 to 326.0
|
295 pg/mL
Interval 251.0 to 414.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MCP-1
|
92 pg/mL
Interval 73.0 to 112.0
|
85.5 pg/mL
Interval 67.0 to 101.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MCP-4
|
1270 pg/mL
Interval 1100.0 to 1630.0
|
1360 pg/mL
Interval 1120.0 to 1600.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MIP-3 alpha
|
16 pg/mL
Interval 12.0 to 23.0
|
17 pg/mL
Interval 14.0 to 28.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MPIF-1
|
1400 pg/mL
Interval 1200.0 to 1800.0
|
2300 pg/mL
Interval 2000.0 to 2600.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
E-selectin
|
6000 pg/mL
Interval 4900.0 to 8900.0
|
5950 pg/mL
Interval 4200.0 to 9500.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-6r
|
24500 pg/mL
Interval 21500.0 to 31000.0
|
26500 pg/mL
Interval 22000.0 to 35000.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
IL-8
|
4.4 pg/mL
Interval 3.8 to 5.6
|
5.1 pg/mL
Interval 4.1 to 6.3
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MCP-2
|
20 pg/mL
Interval 17.0 to 25.0
|
21 pg/mL
Interval 16.0 to 26.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MIG
|
425 pg/mL
Interval 299.0 to 606.0
|
526 pg/mL
Interval 441.0 to 678.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 20.0
|
18 pg/mL
Interval 18.0 to 22.0
|
|
Cytokines and Chemokines Concentrations During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 2Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines/Chemokines Concentrations - Study Step 1
E-selectin
|
6300 pg/mL
Interval 5000.0 to 7400.0
|
5800 pg/mL
Interval 4300.0 to 9300.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.7
|
3.6 pg/mL
Interval 3.3 to 4.3
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-18
|
167 pg/mL
Interval 130.0 to 219.0
|
219 pg/mL
Interval 165.0 to 252.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-6r
|
24000 pg/mL
Interval 20000.0 to 30000.0
|
25000 pg/mL
Interval 18000.0 to 33000.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IP-10
|
214 pg/mL
Interval 174.0 to 303.0
|
455 pg/mL
Interval 291.0 to 569.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MCP-1
|
79 pg/mL
Interval 58.0 to 101.0
|
83 pg/mL
Interval 55.0 to 95.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MCP-2
|
20 pg/mL
Interval 15.0 to 25.0
|
22 pg/mL
Interval 17.0 to 25.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MCP-4
|
1230 pg/mL
Interval 1010.0 to 1390.0
|
1300 pg/mL
Interval 1010.0 to 1600.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MIG
|
364 pg/mL
Interval 255.0 to 620.0
|
546 pg/mL
Interval 435.0 to 593.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MIP-1 beta
|
149 pg/mL
Interval 126.0 to 189.0
|
200 pg/mL
Interval 160.0 to 265.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MIP-3 alpha
|
21 pg/mL
Interval 16.0 to 28.0
|
19 pg/mL
Interval 14.0 to 25.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MPIF-1
|
1300 pg/mL
Interval 890.0 to 1500.0
|
1600 pg/mL
Interval 1300.0 to 2000.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines/Chemokines Concentrations - Study Step 1
IL-8
|
5 pg/mL
Interval 4.2 to 5.6
|
4.8 pg/mL
Interval 3.8 to 6.4
|
|
Cytokines/Chemokines Concentrations - Study Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 21.0
|
18 pg/mL
Interval 18.0 to 22.0
|
|
Cytokines/Chemokines Concentrations - Study Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 7Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MCP-2
|
22.5 pg/mL
Interval 18.0 to 30.0
|
20 pg/mL
Interval 16.0 to 24.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MCP-4
|
1240 pg/mL
Interval 1010.0 to 1420.0
|
1250 pg/mL
Interval 1040.0 to 1390.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-6r
|
25000 pg/mL
Interval 21000.0 to 31000.0
|
27000 pg/mL
Interval 21000.0 to 35000.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-8
|
5.1 pg/mL
Interval 4.2 to 6.7
|
5 pg/mL
Interval 4.2 to 6.9
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IP-10
|
220.5 pg/mL
Interval 185.0 to 279.0
|
235 pg/mL
Interval 178.0 to 350.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MCP-1
|
88.5 pg/mL
Interval 71.0 to 125.0
|
94 pg/mL
Interval 73.0 to 119.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MIG
|
436.5 pg/mL
Interval 304.0 to 687.0
|
475 pg/mL
Interval 384.0 to 582.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 22.0
|
18 pg/mL
Interval 18.0 to 26.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MIP-1 beta
|
173.5 pg/mL
Interval 146.0 to 213.0
|
171 pg/mL
Interval 142.0 to 243.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MIP-3 alpha
|
22 pg/mL
Interval 16.0 to 34.0
|
18 pg/mL
Interval 14.0 to 26.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
MPIF-1
|
1300 pg/mL
Interval 1100.0 to 1500.0
|
1600 pg/mL
Interval 1300.0 to 2100.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 17.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
E-selectin
|
6700 pg/mL
Interval 4800.0 to 8500.0
|
6600 pg/mL
Interval 4100.0 to 8600.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.9
|
3.6 pg/mL
Interval 3.3 to 4.9
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-18
|
191 pg/mL
Interval 126.0 to 231.0
|
202 pg/mL
Interval 168.0 to 265.0
|
|
Cytokines/Chemokines Concentrations in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
PRIMARY outcome
Timeframe: Post-dose1 at Day 30Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
E-selectin
|
6500 pg/mL
Interval 5200.0 to 8000.0
|
6200 pg/mL
Interval 4300.0 to 9000.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.4
|
3.3 pg/mL
Interval 3.3 to 3.4
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-18
|
183 pg/mL
Interval 136.0 to 234.0
|
202 pg/mL
Interval 151.0 to 248.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 2.3
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-6r
|
26000 pg/mL
Interval 21000.0 to 30000.0
|
27000 pg/mL
Interval 20000.0 to 32000.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IL-8
|
4.3 pg/mL
Interval 3.4 to 5.8
|
4.8 pg/mL
Interval 3.9 to 6.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
IP-10
|
235 pg/mL
Interval 183.0 to 264.0
|
245 pg/mL
Interval 211.0 to 349.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MCP-1
|
86 pg/mL
Interval 72.0 to 111.0
|
99 pg/mL
Interval 72.0 to 136.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MCP-2
|
20 pg/mL
Interval 14.0 to 24.0
|
16 pg/mL
Interval 14.0 to 23.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MCP-4
|
1010 pg/mL
Interval 937.0 to 1210.0
|
1180 pg/mL
Interval 937.0 to 1340.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MIG
|
452 pg/mL
Interval 281.0 to 691.0
|
475 pg/mL
Interval 393.0 to 768.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MIP-1 beta
|
147 pg/mL
Interval 126.0 to 181.0
|
175 pg/mL
Interval 141.0 to 240.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MIP-3 alpha
|
20 pg/mL
Interval 16.0 to 27.0
|
20 pg/mL
Interval 15.0 to 30.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
MPIF-1
|
1300 pg/mL
Interval 940.0 to 1500.0
|
1500 pg/mL
Interval 1300.0 to 1800.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Cytokines/Chemokines Concentrations During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 1.5 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 4.3
|
3.3 pg/mL
Interval 3.3 to 4.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
E-selectin
|
5700 pg/mL
Interval 4900.0 to 6800.0
|
6300 pg/mL
Interval 3900.0 to 7600.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-6r
|
25000 pg/mL
Interval 20000.0 to 31000.0
|
24000 pg/mL
Interval 18000.0 to 30000.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-8
|
4.3 pg/mL
Interval 2.7 to 5.0
|
3.2 pg/mL
Interval 3.0 to 5.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IP-10
|
215 pg/mL
Interval 173.0 to 247.0
|
223 pg/mL
Interval 189.0 to 336.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MCP-1
|
87 pg/mL
Interval 66.0 to 104.0
|
85 pg/mL
Interval 58.0 to 112.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MCP-2
|
18 pg/mL
Interval 15.0 to 22.0
|
15 pg/mL
Interval 12.0 to 23.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MCP-4
|
1090 pg/mL
Interval 1020.0 to 1330.0
|
1250 pg/mL
Interval 1030.0 to 1400.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MIP-1 beta
|
136 pg/mL
Interval 115.0 to 170.0
|
164 pg/mL
Interval 132.0 to 196.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MPIF-1
|
1200 pg/mL
Interval 930.0 to 1500.0
|
1400 pg/mL
Interval 1200.0 to 1500.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MIG
|
367 pg/mL
Interval 269.0 to 575.0
|
421 pg/mL
Interval 361.0 to 856.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 20.0
|
18 pg/mL
Interval 18.0 to 22.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
MIP-3 alpha
|
14 pg/mL
Interval 11.0 to 19.0
|
17 pg/mL
Interval 10.0 to 22.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Step 1
IL-18
|
176 pg/mL
Interval 127.0 to 207.0
|
171 pg/mL
Interval 143.0 to 223.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 3 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=24 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.5
|
18 pg/mL
Interval 18.0 to 20.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.4
|
3.3 pg/mL
Interval 3.3 to 4.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-8
|
4.5 pg/mL
Interval 3.8 to 5.0
|
4.7 pg/mL
Interval 3.9 to 6.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IP-10
|
205.5 pg/mL
Interval 176.0 to 243.5
|
208 pg/mL
Interval 182.0 to 275.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MCP-4
|
1085 pg/mL
Interval 824.5 to 1250.0
|
1095 pg/mL
Interval 979.0 to 1410.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MIG
|
358 pg/mL
Interval 237.0 to 650.5
|
378.5 pg/mL
Interval 313.0 to 513.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MIP-1 beta
|
138 pg/mL
Interval 123.5 to 157.5
|
153 pg/mL
Interval 135.0 to 220.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
E-selectin
|
5700 pg/mL
Interval 4450.0 to 6850.0
|
6550 pg/mL
Interval 4000.0 to 8200.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-18
|
158 pg/mL
Interval 104.0 to 206.5
|
171.5 pg/mL
Interval 146.0 to 204.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MCP-1
|
75 pg/mL
Interval 51.0 to 85.0
|
75 pg/mL
Interval 62.0 to 95.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MCP-2
|
18 pg/mL
Interval 14.5 to 22.5
|
15.5 pg/mL
Interval 12.0 to 27.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 2.5
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
IL-6r
|
23000 pg/mL
Interval 19000.0 to 28500.0
|
26000 pg/mL
Interval 18000.0 to 31000.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MIP-3 alpha
|
14 pg/mL
Interval 10.0 to 15.5
|
15 pg/mL
Interval 10.0 to 22.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
MPIF-1
|
1200 pg/mL
Interval 980.0 to 1450.0
|
1500 pg/mL
Interval 1200.0 to 1600.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 6 hoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
E-selectin
|
5850 pg/mL
Interval 4550.0 to 7000.0
|
6000 pg/mL
Interval 4200.0 to 8100.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.7
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-18
|
183 pg/mL
Interval 127.5 to 211.5
|
173.5 pg/mL
Interval 151.0 to 227.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
4.4 pg/mL
Interval 2.8 to 6.7
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-6r
|
24500 pg/mL
Interval 20500.0 to 30500.0
|
23000 pg/mL
Interval 18000.0 to 29000.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IL-8
|
4.5 pg/mL
Interval 3.5 to 5.2
|
5.2 pg/mL
Interval 3.5 to 6.7
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
IP-10
|
196.5 pg/mL
Interval 160.0 to 248.5
|
210.5 pg/mL
Interval 182.0 to 248.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-1
|
95 pg/mL
Interval 79.0 to 121.0
|
116.5 pg/mL
Interval 98.0 to 132.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-4
|
1065 pg/mL
Interval 936.0 to 1350.0
|
1245 pg/mL
Interval 954.0 to 1590.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MIG
|
387.5 pg/mL
Interval 239.0 to 671.0
|
375 pg/mL
Interval 320.0 to 505.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-1 beta
|
139.5 pg/mL
Interval 127.5 to 163.5
|
177.5 pg/mL
Interval 128.0 to 225.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MIP-3 alpha
|
16 pg/mL
Interval 12.0 to 22.0
|
16 pg/mL
Interval 10.0 to 24.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MPIF-1
|
1300 pg/mL
Interval 1015.0 to 1700.0
|
1400 pg/mL
Interval 1200.0 to 1600.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 1 of Study
MCP-2
|
18.5 pg/mL
Interval 15.0 to 24.0
|
17 pg/mL
Interval 12.0 to 24.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 9 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=24 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
E-selectin
|
5500 pg/mL
Interval 4350.0 to 6850.0
|
6200 pg/mL
Interval 4100.0 to 7400.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-18
|
165 pg/mL
Interval 115.0 to 229.5
|
177 pg/mL
Interval 139.0 to 240.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 6.6
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
4.8 pg/mL
Interval 3.2 to 6.7
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-6r
|
24500 pg/mL
Interval 18500.0 to 30500.0
|
23000 pg/mL
Interval 17000.0 to 30000.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-8
|
4 pg/mL
Interval 3.2 to 5.4
|
4.1 pg/mL
Interval 3.2 to 5.5
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IP-10
|
204 pg/mL
Interval 168.0 to 234.0
|
217 pg/mL
Interval 180.0 to 326.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-1
|
80 pg/mL
Interval 55.0 to 106.0
|
103 pg/mL
Interval 88.0 to 119.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-2
|
18.5 pg/mL
Interval 14.5 to 20.5
|
18 pg/mL
Interval 14.0 to 24.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MCP-4
|
1075 pg/mL
Interval 820.0 to 1295.0
|
1190 pg/mL
Interval 999.0 to 1470.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MIG
|
350 pg/mL
Interval 300.0 to 620.0
|
424 pg/mL
Interval 384.0 to 621.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-1 beta
|
123.5 pg/mL
Interval 108.5 to 146.5
|
167 pg/mL
Interval 120.0 to 220.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MIP-3 alpha
|
15.5 pg/mL
Interval 11.0 to 19.0
|
16 pg/mL
Interval 14.0 to 23.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
MPIF-1
|
1200 pg/mL
Interval 950.0 to 1400.0
|
1400 pg/mL
Interval 1100.0 to 1600.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.4
|
3.3 pg/mL
Interval 3.3 to 5.2
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 12 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
2.3 pg/mL
Interval 1.6 to 3.1
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.8
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-18
|
174 pg/mL
Interval 124.0 to 220.0
|
166 pg/mL
Interval 146.0 to 212.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.7
|
6.4 pg/mL
Interval 5.0 to 9.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-6r
|
24000 pg/mL
Interval 21000.0 to 32000.0
|
23000 pg/mL
Interval 21000.0 to 31000.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IL-8
|
5.2 pg/mL
Interval 3.2 to 6.0
|
4.9 pg/mL
Interval 4.1 to 6.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
IP-10
|
200 pg/mL
Interval 166.0 to 240.0
|
240 pg/mL
Interval 228.0 to 335.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MCP-1
|
95 pg/mL
Interval 71.0 to 121.0
|
117 pg/mL
Interval 96.0 to 150.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MCP-2
|
18 pg/mL
Interval 15.0 to 22.0
|
20 pg/mL
Interval 14.0 to 26.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MCP-4
|
1040 pg/mL
Interval 852.0 to 1170.0
|
1100 pg/mL
Interval 916.0 to 1330.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MIG
|
377 pg/mL
Interval 290.0 to 689.0
|
499 pg/mL
Interval 398.0 to 872.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 20.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MIP-1 beta
|
134 pg/mL
Interval 118.0 to 162.0
|
191 pg/mL
Interval 162.0 to 238.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MIP-3 alpha
|
14 pg/mL
Interval 11.0 to 20.0
|
20 pg/mL
Interval 15.0 to 26.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
MPIF-1
|
1300 pg/mL
Interval 1100.0 to 1500.0
|
1500 pg/mL
Interval 1100.0 to 1700.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Plasma Concentrations of Cytokines/Chemokines During Step 1 of Study
E-selectin
|
5800 pg/mL
Interval 4500.0 to 7000.0
|
5800 pg/mL
Interval 4000.0 to 7800.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 30 plus 18 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=14 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
E-selectin
|
4500 pg/mL
Interval 2900.0 to 5800.0
|
5400 pg/mL
Interval 3400.0 to 8000.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
5.2 pg/mL
Interval 1.6 to 7.4
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.4
|
4.5 pg/mL
Interval 3.3 to 6.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-18
|
168 pg/mL
Interval 128.0 to 197.0
|
164.5 pg/mL
Interval 151.0 to 241.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
6.3 pg/mL
Interval 4.2 to 8.3
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-6r
|
24000 pg/mL
Interval 17000.0 to 32000.0
|
19500 pg/mL
Interval 13000.0 to 24000.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-8
|
5 pg/mL
Interval 3.5 to 5.9
|
4.8 pg/mL
Interval 4.1 to 5.4
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IP-10
|
216 pg/mL
Interval 196.0 to 430.0
|
589.5 pg/mL
Interval 296.0 to 715.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MCP-1
|
96 pg/mL
Interval 91.0 to 106.0
|
104.5 pg/mL
Interval 76.0 to 116.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MCP-2
|
22 pg/mL
Interval 16.0 to 23.0
|
33 pg/mL
Interval 19.0 to 54.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MCP-4
|
1260 pg/mL
Interval 1000.0 to 1340.0
|
1220 pg/mL
Interval 1090.0 to 1290.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MIG
|
442 pg/mL
Interval 300.0 to 633.0
|
565.5 pg/mL
Interval 373.0 to 791.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 23.0
|
18 pg/mL
Interval 18.0 to 23.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MIP-1 beta
|
144 pg/mL
Interval 111.0 to 176.0
|
283.5 pg/mL
Interval 228.0 to 327.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MIP-3 alpha
|
17 pg/mL
Interval 11.0 to 20.0
|
24 pg/mL
Interval 19.0 to 31.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
MPIF-1
|
1400 pg/mL
Interval 1100.0 to 1700.0
|
1600 pg/mL
Interval 1300.0 to 2300.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Plasma Concentrations of Cytokines/Chemokines - Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 31Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
E-selectin
|
5800 pg/mL
Interval 5200.0 to 7100.0
|
6800 pg/mL
Interval 4300.0 to 8200.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
4.8 pg/mL
Interval 1.7 to 8.6
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
4.8 pg/mL
Interval 3.3 to 6.3
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-18
|
166 pg/mL
Interval 137.0 to 217.0
|
185 pg/mL
Interval 151.0 to 258.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-2
|
5.9 pg/mL
Interval 5.9 to 8.5
|
8.5 pg/mL
Interval 5.9 to 8.5
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
3.6 pg/mL
Interval 1.7 to 7.2
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-6r
|
24000 pg/mL
Interval 22000.0 to 31000.0
|
26000 pg/mL
Interval 17000.0 to 33000.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IL-8
|
4.8 pg/mL
Interval 3.9 to 5.9
|
5.6 pg/mL
Interval 4.8 to 7.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
IP-10
|
212 pg/mL
Interval 197.0 to 270.0
|
763 pg/mL
Interval 405.0 to 1130.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MCP-2
|
17 pg/mL
Interval 14.0 to 19.0
|
35 pg/mL
Interval 19.0 to 67.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MCP-4
|
1090 pg/mL
Interval 912.0 to 1330.0
|
1250 pg/mL
Interval 1090.0 to 1400.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MIG
|
427 pg/mL
Interval 308.0 to 597.0
|
763 pg/mL
Interval 604.0 to 1260.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 21.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MIP-1 beta
|
142 pg/mL
Interval 120.0 to 176.0
|
383 pg/mL
Interval 301.0 to 540.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
15 pg/mL
Interval 13.0 to 21.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MCP-1
|
71 pg/mL
Interval 60.0 to 93.0
|
101 pg/mL
Interval 79.0 to 137.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MIP-3 alpha
|
19 pg/mL
Interval 12.0 to 28.0
|
22 pg/mL
Interval 17.0 to 25.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
MPIF-1
|
1100 pg/mL
Interval 950.0 to 1600.0
|
2000 pg/mL
Interval 1500.0 to 2300.0
|
|
Plasma Concentrations of Cytokines/Chemokines in Step 1 of Study
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 32Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 7.0
|
5.9 pg/mL
Interval 5.9 to 7.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-8
|
5.1 pg/mL
Interval 4.0 to 6.5
|
5.5 pg/mL
Interval 4.3 to 6.5
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MIG
|
410 pg/mL
Interval 320.0 to 581.0
|
850 pg/mL
Interval 667.0 to 1070.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MPIF-1
|
1200 pg/mL
Interval 990.0 to 1700.0
|
1800 pg/mL
Interval 1400.0 to 2300.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 14.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
E-selectin
|
6000 pg/mL
Interval 4900.0 to 8000.0
|
7000 pg/mL
Interval 4400.0 to 9100.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.5
|
3.5 pg/mL
Interval 3.3 to 5.3
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-18
|
190 pg/mL
Interval 135.0 to 238.0
|
238 pg/mL
Interval 195.0 to 269.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 2.5
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IL-6r
|
24000 pg/mL
Interval 21000.0 to 31000.0
|
27000 pg/mL
Interval 21000.0 to 32000.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
IP-10
|
226 pg/mL
Interval 192.0 to 276.0
|
760 pg/mL
Interval 492.0 to 993.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MCP-1
|
77 pg/mL
Interval 65.0 to 121.0
|
75 pg/mL
Interval 55.0 to 94.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MCP-2
|
21 pg/mL
Interval 17.0 to 25.0
|
24 pg/mL
Interval 17.0 to 31.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MCP-4
|
1260 pg/mL
Interval 1010.0 to 1560.0
|
1350 pg/mL
Interval 1080.0 to 1580.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 23.0
|
18 pg/mL
Interval 18.0 to 19.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MIP-1 beta
|
142 pg/mL
Interval 124.0 to 171.0
|
268 pg/mL
Interval 222.0 to 307.0
|
|
Concentrations of Plasma Cytokines and Chemokines - Step 1
MIP-3 alpha
|
19 pg/mL
Interval 13.0 to 28.0
|
23 pg/mL
Interval 16.0 to 30.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 33Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-6r
|
25000 pg/mL
Interval 21000.0 to 28000.0
|
26000 pg/mL
Interval 21000.0 to 33000.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MIG
|
537 pg/mL
Interval 456.0 to 722.0
|
796 pg/mL
Interval 586.0 to 908.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MIP-1 beta
|
163 pg/mL
Interval 135.0 to 201.0
|
241 pg/mL
Interval 175.0 to 279.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MPIF-1
|
1300 pg/mL
Interval 1100.0 to 1600.0
|
1800 pg/mL
Interval 1400.0 to 2200.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.4
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
E-selectin
|
6300 pg/mL
Interval 5100.0 to 8000.0
|
6400 pg/mL
Interval 4400.0 to 8700.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.6
|
3.3 pg/mL
Interval 3.3 to 3.6
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-18
|
181 pg/mL
Interval 142.0 to 231.0
|
256 pg/mL
Interval 195.0 to 351.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IL-8
|
5.5 pg/mL
Interval 4.3 to 6.2
|
5.5 pg/mL
Interval 4.3 to 7.4
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
IP-10
|
249 pg/mL
Interval 220.0 to 319.0
|
366 pg/mL
Interval 288.0 to 524.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MCP-1
|
93 pg/mL
Interval 77.0 to 131.0
|
85 pg/mL
Interval 65.0 to 101.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MCP-2
|
20 pg/mL
Interval 17.0 to 26.0
|
20 pg/mL
Interval 16.0 to 28.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MCP-4
|
1280 pg/mL
Interval 1090.0 to 1600.0
|
1390 pg/mL
Interval 1190.0 to 1600.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MIP-1 alpha
|
19 pg/mL
Interval 18.0 to 22.0
|
22 pg/mL
Interval 18.0 to 24.0
|
|
Concentrations of Plasma Cytokines and Chemokines in Step 1
MIP-3 alpha
|
25 pg/mL
Interval 21.0 to 32.0
|
25 pg/mL
Interval 21.0 to 40.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 37Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
E-selectin
|
6000 pg/mL
Interval 5000.0 to 7700.0
|
6200 pg/mL
Interval 4000.0 to 8200.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-18
|
166 pg/mL
Interval 123.0 to 196.0
|
194 pg/mL
Interval 156.0 to 256.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-6r
|
25000 pg/mL
Interval 20000.0 to 27000.0
|
28000 pg/mL
Interval 16000.0 to 35000.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IL-8
|
5.5 pg/mL
Interval 4.6 to 6.0
|
5.3 pg/mL
Interval 3.9 to 6.6
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
IP-10
|
223 pg/mL
Interval 179.0 to 289.0
|
259 pg/mL
Interval 213.0 to 296.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MCP-1
|
85 pg/mL
Interval 63.0 to 99.0
|
83 pg/mL
Interval 66.0 to 109.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MCP-2
|
20 pg/mL
Interval 16.0 to 24.0
|
17 pg/mL
Interval 13.0 to 23.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MCP-4
|
1210 pg/mL
Interval 1010.0 to 1340.0
|
1220 pg/mL
Interval 1110.0 to 1480.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MIG
|
364 pg/mL
Interval 284.0 to 472.0
|
447 pg/mL
Interval 398.0 to 535.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 19.0
|
18 pg/mL
Interval 18.0 to 23.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MIP-1 beta
|
151 pg/mL
Interval 126.0 to 175.0
|
150 pg/mL
Interval 119.0 to 190.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MIP-3 alpha
|
18 pg/mL
Interval 15.0 to 24.0
|
18 pg/mL
Interval 15.0 to 28.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
MPIF-1
|
1300 pg/mL
Interval 1000.0 to 1400.0
|
1600 pg/mL
Interval 1200.0 to 1800.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Plasma Cytokines and Chemokines During Step 1
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Pre-dose 1 at Day 0Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.
Outcome measures
| Measure |
Engerix-B_1 Group
n=9 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=6 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-3
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-6r
|
30000 pg/mL
Interval 28000.0 to 36000.0
|
32000 pg/mL
Interval 29000.0 to 36000.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
E-selectin
|
5400 pg/mL
Interval 4400.0 to 5500.0
|
8100 pg/mL
Interval 4200.0 to 8900.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
GM-CSF
|
14 pg/mL
Interval 14.0 to 14.0
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
IFN-γ
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-10
|
3.3 pg/mL
Interval 3.3 to 3.3
|
3.3 pg/mL
Interval 3.3 to 3.8
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-18
|
179 pg/mL
Interval 152.0 to 182.0
|
199.5 pg/mL
Interval 175.0 to 377.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-2
|
5.9 pg/mL
Interval 5.9 to 5.9
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-5
|
2.7 pg/mL
Interval 2.7 to 2.7
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-7
|
8.2 pg/mL
Interval 8.2 to 8.2
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines and Chemokines - Step 2
IL-8
|
4.4 pg/mL
Interval 3.5 to 6.2
|
5.3 pg/mL
Interval 3.5 to 11.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
IP-10
|
234 pg/mL
Interval 166.0 to 278.0
|
300.5 pg/mL
Interval 275.0 to 370.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MCP-1
|
87 pg/mL
Interval 67.0 to 96.0
|
86.5 pg/mL
Interval 77.0 to 132.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MCP-2
|
27 pg/mL
Interval 19.0 to 30.0
|
22.5 pg/mL
Interval 17.0 to 27.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MCP-4
|
2120 pg/mL
Interval 1720.0 to 2260.0
|
1805 pg/mL
Interval 1300.0 to 2010.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MIP-1 alpha
|
18 pg/mL
Interval 18.0 to 18.0
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MIP-1 beta
|
253 pg/mL
Interval 200.0 to 300.0
|
234 pg/mL
Interval 186.0 to 255.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MIP-3 alpha
|
29 pg/mL
Interval 17.0 to 42.0
|
28.5 pg/mL
Interval 23.0 to 64.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
MPIF-1
|
1100 pg/mL
Interval 930.0 to 1200.0
|
1095 pg/mL
Interval 820.0 to 1200.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
TNF-alpha
|
13 pg/mL
Interval 13.0 to 13.0
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines - Step 2
TNF-beta
|
3 pg/mL
Interval 3.0 to 3.0
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 1 at Day 1Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=7 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Cytokines and Chemokines Concentrations - Step 2
E-selectin
|
—
|
7900 pg/mL
Interval 4300.0 to 9100.0
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-6r
|
—
|
24000 pg/mL
Interval 22000.0 to 33000.0
|
|
Cytokines and Chemokines Concentrations - Step 2
MCP-1
|
—
|
35 pg/mL
Interval 27.0 to 114.0
|
|
Cytokines and Chemokines Concentrations - Step 2
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Cytokines and Chemokines Concentrations - Step 2
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Cytokines and Chemokines Concentrations - Step 2
IFN-γ
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-10
|
—
|
3.8 pg/mL
Interval 3.3 to 4.7
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-18
|
—
|
206 pg/mL
Interval 182.0 to 260.0
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-4
|
—
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-6
|
—
|
1.7 pg/mL
Interval 1.6 to 2.6
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-7
|
—
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Cytokines and Chemokines Concentrations - Step 2
IL-8
|
—
|
3.9 pg/mL
Interval 2.6 to 7.1
|
|
Cytokines and Chemokines Concentrations - Step 2
IP-10
|
—
|
294 pg/mL
Interval 199.0 to 390.0
|
|
Cytokines and Chemokines Concentrations - Step 2
MCP-2
|
—
|
26 pg/mL
Interval 20.0 to 29.0
|
|
Cytokines and Chemokines Concentrations - Step 2
MCP-4
|
—
|
1240 pg/mL
Interval 1130.0 to 1640.0
|
|
Cytokines and Chemokines Concentrations - Step 2
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 32.0
|
|
Cytokines and Chemokines Concentrations - Step 2
MIP-1 beta
|
—
|
318 pg/mL
Interval 241.0 to 391.0
|
|
Cytokines and Chemokines Concentrations - Step 2
MIP-3 alpha
|
—
|
32 pg/mL
Interval 17.0 to 46.0
|
|
Cytokines and Chemokines Concentrations - Step 2
MPIF-1
|
—
|
1400 pg/mL
Interval 1200.0 to 1500.0
|
|
Cytokines and Chemokines Concentrations - Step 2
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
PRIMARY outcome
Timeframe: Post-dose 1 at Day 30Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines During Step 2
IFN-γ
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-6
|
—
|
1.6 pg/mL
Interval 1.6 to 1.7
|
|
Concentrations of Cytokines and Chemokines During Step 2
IP-10
|
—
|
231.5 pg/mL
Interval 160.5 to 318.5
|
|
Concentrations of Cytokines and Chemokines During Step 2
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines During Step 2
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 3.0
|
|
Concentrations of Cytokines and Chemokines During Step 2
E-selectin
|
—
|
6200 pg/mL
Interval 3600.0 to 8450.0
|
|
Concentrations of Cytokines and Chemokines During Step 2
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-10
|
—
|
3.3 pg/mL
Interval 3.3 to 3.6
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-18
|
—
|
166.5 pg/mL
Interval 132.5 to 271.5
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-4
|
—
|
9.4 pg/mL
Interval 9.4 to 11.2
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-6r
|
—
|
29000 pg/mL
Interval 24500.0 to 33500.0
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-7
|
—
|
8.2 pg/mL
Interval 8.2 to 10.1
|
|
Concentrations of Cytokines and Chemokines During Step 2
IL-8
|
—
|
4.3 pg/mL
Interval 3.1 to 8.4
|
|
Concentrations of Cytokines and Chemokines During Step 2
MCP-1
|
—
|
46 pg/mL
Interval 35.0 to 115.5
|
|
Concentrations of Cytokines and Chemokines During Step 2
MCP-2
|
—
|
19.5 pg/mL
Interval 17.0 to 20.5
|
|
Concentrations of Cytokines and Chemokines During Step 2
MCP-4
|
—
|
1340 pg/mL
Interval 1115.0 to 1450.0
|
|
Concentrations of Cytokines and Chemokines During Step 2
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Concentrations of Cytokines and Chemokines During Step 2
MIP-1 beta
|
—
|
172 pg/mL
Interval 158.5 to 196.5
|
|
Concentrations of Cytokines and Chemokines During Step 2
MIP-3 alpha
|
—
|
25 pg/mL
Interval 15.0 to 30.5
|
|
Concentrations of Cytokines and Chemokines During Step 2
MPIF-1
|
—
|
1200 pg/mL
Interval 855.0 to 1400.0
|
PRIMARY outcome
Timeframe: Post-dose2 at Day 30 plus 6 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=7 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-7
|
—
|
12 pg/mL
Interval 8.2 to 21.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 6.3
|
|
Concentrations of Cytokines and Chemokines in Step 2
E-selectin
|
—
|
5400 pg/mL
Interval 3400.0 to 8300.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
IFN-γ
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-10
|
—
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-18
|
—
|
172 pg/mL
Interval 150.0 to 247.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-4
|
—
|
9.4 pg/mL
Interval 9.4 to 10.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-6
|
—
|
3.7 pg/mL
Interval 1.6 to 4.7
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-6r
|
—
|
34000 pg/mL
Interval 27000.0 to 43000.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
IL-8
|
—
|
6.1 pg/mL
Interval 3.6 to 9.1
|
|
Concentrations of Cytokines and Chemokines in Step 2
IP-10
|
—
|
163 pg/mL
Interval 128.0 to 205.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
MCP-1
|
—
|
59 pg/mL
Interval 27.0 to 86.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
MCP-2
|
—
|
22 pg/mL
Interval 18.0 to 25.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
MCP-4
|
—
|
1330 pg/mL
Interval 979.0 to 1540.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
MIP-1 beta
|
—
|
182 pg/mL
Interval 154.0 to 266.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
MIP-3 alpha
|
—
|
21 pg/mL
Interval 13.0 to 28.0
|
|
Concentrations of Cytokines and Chemokines in Step 2
MPIF-1
|
—
|
1300 pg/mL
Interval 980.0 to 1700.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 31Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-7
|
—
|
10.1 pg/mL
Interval 8.2 to 23.5
|
|
Concentrations of Cytokines/Chemokines - Step 2
E-selectin
|
—
|
7450 pg/mL
Interval 4600.0 to 10500.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
IFN-γ
|
—
|
6.2 pg/mL
Interval 3.4 to 17.6
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-10
|
—
|
3.3 pg/mL
Interval 3.3 to 4.4
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-18
|
—
|
234 pg/mL
Interval 181.0 to 339.5
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-4
|
—
|
9.7 pg/mL
Interval 9.4 to 10.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-6
|
—
|
4 pg/mL
Interval 2.2 to 5.7
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-6r
|
—
|
30500 pg/mL
Interval 27000.0 to 41500.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
IL-8
|
—
|
7.9 pg/mL
Interval 7.3 to 10.9
|
|
Concentrations of Cytokines/Chemokines - Step 2
IP-10
|
—
|
737.5 pg/mL
Interval 510.0 to 1270.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
MCP-1
|
—
|
142.5 pg/mL
Interval 104.0 to 153.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
MCP-2
|
—
|
40.5 pg/mL
Interval 32.0 to 72.5
|
|
Concentrations of Cytokines/Chemokines - Step 2
MCP-4
|
—
|
1330 pg/mL
Interval 974.0 to 1780.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
MIP-1 beta
|
—
|
580 pg/mL
Interval 359.5 to 780.5
|
|
Concentrations of Cytokines/Chemokines - Step 2
MIP-3 alpha
|
—
|
28 pg/mL
Interval 19.0 to 39.5
|
|
Concentrations of Cytokines/Chemokines - Step 2
MPIF-1
|
—
|
1750 pg/mL
Interval 1500.0 to 1850.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines - Step 2
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 37Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the HBsAg/AS\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines in Step 2
E-selectin
|
—
|
6550 pg/mL
Interval 3250.0 to 8450.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
IFN-γ
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-10
|
—
|
3.3 pg/mL
Interval 3.3 to 3.8
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-18
|
—
|
232 pg/mL
Interval 145.5 to 322.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-4
|
—
|
9.7 pg/mL
Interval 9.4 to 14.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-6
|
—
|
1.6 pg/mL
Interval 1.6 to 1.7
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-6r
|
—
|
28000 pg/mL
Interval 26500.0 to 34500.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-7
|
—
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines/Chemokines in Step 2
IL-8
|
—
|
8.5 pg/mL
Interval 6.7 to 9.7
|
|
Concentrations of Cytokines/Chemokines in Step 2
IP-10
|
—
|
170 pg/mL
Interval 143.0 to 210.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
MCP-1
|
—
|
72.5 pg/mL
Interval 27.0 to 104.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
MCP-2
|
—
|
18.5 pg/mL
Interval 15.0 to 23.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
MCP-4
|
—
|
1275 pg/mL
Interval 881.5 to 1635.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
MIP-1 beta
|
—
|
174 pg/mL
Interval 152.5 to 187.5
|
|
Concentrations of Cytokines/Chemokines in Step 2
MIP-3 alpha
|
—
|
17 pg/mL
Interval 11.5 to 94.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
MPIF-1
|
—
|
1100 pg/mL
Interval 995.0 to 1450.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines in Step 2
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 11.2
|
PRIMARY outcome
Timeframe: Post-dose 2 at Day 180Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=9 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-7
|
—
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Concentrations of Cytokines/Chemokines During Step 2
E-selectin
|
—
|
4900 pg/mL
Interval 4300.0 to 5800.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
IFN-γ
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-10
|
—
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-18
|
—
|
159 pg/mL
Interval 144.0 to 190.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-4
|
—
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-6
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-6r
|
—
|
24000 pg/mL
Interval 24000.0 to 32000.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
IL-8
|
—
|
4.4 pg/mL
Interval 3.5 to 5.3
|
|
Concentrations of Cytokines/Chemokines During Step 2
IP-10
|
—
|
156 pg/mL
Interval 121.0 to 260.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
MCP-1
|
—
|
77 pg/mL
Interval 57.0 to 77.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
MCP-2
|
—
|
20 pg/mL
Interval 14.0 to 27.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
MCP-4
|
—
|
1640 pg/mL
Interval 1540.0 to 1810.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
MIP-1 beta
|
—
|
189 pg/mL
Interval 177.0 to 257.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
MIP-3 alpha
|
—
|
25 pg/mL
Interval 13.0 to 32.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
MPIF-1
|
—
|
920 pg/mL
Interval 830.0 to 970.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Concentrations of Cytokines/Chemokines During Step 2
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 3 at Day 180 plus 6 HoursPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma.The analysis was performed only on theEngerix-B\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=9 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IP-10
|
—
|
145 pg/mL
Interval 105.0 to 214.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
E-selectin
|
—
|
4600 pg/mL
Interval 4100.0 to 5800.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IFN-γ
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-10
|
—
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-18
|
—
|
144 pg/mL
Interval 133.0 to 152.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-4
|
—
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-6
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-6r
|
—
|
25000 pg/mL
Interval 24000.0 to 30000.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-7
|
—
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
IL-8
|
—
|
3.5 pg/mL
Interval 2.6 to 4.4
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MCP-1
|
—
|
46 pg/mL
Interval 35.0 to 67.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MCP-2
|
—
|
22 pg/mL
Interval 15.0 to 26.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MCP-4
|
—
|
1640 pg/mL
Interval 1350.0 to 1720.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MIP-1 beta
|
—
|
193 pg/mL
Interval 175.0 to 211.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MIP-3 alpha
|
—
|
21 pg/mL
Interval 15.0 to 25.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
MPIF-1
|
—
|
890 pg/mL
Interval 840.0 to 1100.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines - Study Step 2
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 3 at Day 181Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to 30 days post last vaccination (step 2 only), which included all evaluable subjects, who complied with the protocol, and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point.
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MPIF-1
|
—
|
875 pg/mL
Interval 745.0 to 1100.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
E-selectin
|
—
|
4900 pg/mL
Interval 4300.0 to 5900.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IFN-γ
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-10
|
—
|
3.3 pg/mL
Interval 3.3 to 3.8
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-18
|
—
|
152 pg/mL
Interval 140.5 to 192.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-4
|
—
|
9.4 pg/mL
Interval 9.4 to 11.2
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-6
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-6r
|
—
|
24500 pg/mL
Interval 22500.0 to 31500.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-7
|
—
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IL-8
|
—
|
3.5 pg/mL
Interval 2.6 to 3.5
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
IP-10
|
—
|
152 pg/mL
Interval 119.5 to 211.5
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MCP-1
|
—
|
67 pg/mL
Interval 35.0 to 86.5
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MCP-2
|
—
|
19.5 pg/mL
Interval 13.0 to 25.5
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MCP-4
|
—
|
1720 pg/mL
Interval 1390.0 to 1790.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MIP-1 beta
|
—
|
173.5 pg/mL
Interval 166.5 to 213.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
MIP-3 alpha
|
—
|
17 pg/mL
Interval 15.0 to 21.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines in Step 2 of Study
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 3.0
|
PRIMARY outcome
Timeframe: Post-dose 3 at Day 187Population: The analysis was performed on the According-To-Protocol (ATP) cohort for innate immunogenicity up to Day 60 (step 1 only), which included all evaluable subjects, who complied with the protocol and for whom data concerning innate immunogenicity were available for at least one innate assay at one post-vaccination time point (up to Day 60).
Cytokines and chemokines analysed were E-selectin, granulocyte macrophage colony-stimulating factor (GM-CSF), interferon-γ (IFN-γ), interleukin-10 (IL-10), IL-18, IL-2, IL-3, IL-4, IL-5, IL-6, IL-6r, IL-7, IL-8, IFN-γ-inducible protein (IP-10), monocyte chemoattractant protein-1 (MCP-1), MCP-2, MCP-4, monokine induced by IFN-γ (MIG), macrophage inflammatory protein-1 alpha (MIP-1 alpha), MIP-1 beta, MIP3-alpha, MPIF-1, tumor necrosis factor-alpha (TNF-alpha) and TNF-beta. Concentrations are presented as median, expressed in picogram/milliliter (pg/mL), as measured by Multiplex in plasma. The analysis was performed only on the Engerix-B\_2 Group.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=5 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-5
|
—
|
2.7 pg/mL
Interval 2.7 to 2.7
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MIP-1 alpha
|
—
|
18 pg/mL
Interval 18.0 to 18.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MIP-1 beta
|
—
|
175 pg/mL
Interval 175.0 to 193.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
E-selectin
|
—
|
4600 pg/mL
Interval 4200.0 to 5500.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
GM-CSF
|
—
|
14 pg/mL
Interval 14.0 to 14.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IFN-γ
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-10
|
—
|
3.3 pg/mL
Interval 3.3 to 3.3
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-18
|
—
|
163 pg/mL
Interval 137.0 to 167.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-2
|
—
|
5.9 pg/mL
Interval 5.9 to 5.9
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-3
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-4
|
—
|
9.4 pg/mL
Interval 9.4 to 9.4
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-6
|
—
|
1.6 pg/mL
Interval 1.6 to 1.6
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-6r
|
—
|
30000 pg/mL
Interval 26000.0 to 35000.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-7
|
—
|
8.2 pg/mL
Interval 8.2 to 8.2
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IL-8
|
—
|
3.5 pg/mL
Interval 3.5 to 4.4
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
IP-10
|
—
|
201 pg/mL
Interval 107.0 to 201.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MCP-1
|
—
|
35 pg/mL
Interval 35.0 to 35.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MCP-2
|
—
|
22 pg/mL
Interval 17.0 to 25.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MCP-4
|
—
|
1810 pg/mL
Interval 1720.0 to 2120.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MIP-3 alpha
|
—
|
17 pg/mL
Interval 17.0 to 25.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
MPIF-1
|
—
|
820 pg/mL
Interval 750.0 to 970.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
TNF-alpha
|
—
|
13 pg/mL
Interval 13.0 to 13.0
|
|
Plasma Concentrations of Cytokines and Chemokines During Step 2 of Study
TNF-beta
|
—
|
3 pg/mL
Interval 3.0 to 3.0
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and Day 60 (D60) post-vaccinationPopulation: The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).
Anti-HBs antibody concentrations in serum were measured by Chemi Luminiscence Immuno Assay (CLIA). Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1
Anti-HBs, PRE (D0)
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 1
Anti-HBs, PII (D60)
|
35.8 mIU/mL
Interval 11.6 to 111.1
|
3322.4 mIU/mL
Interval 2332.2 to 4733.0
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 pain, PP
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any redness, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any redness, Across Doses
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any pain, PP
|
3 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 redness, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any swelling, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 swelling, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any pain, D1
|
7 Participants
|
18 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 pain, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any redness, D1
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 redness, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any swelling, D1
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 swelling, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any pain, D2
|
6 Participants
|
15 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 pain, D2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any redness, D2
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 redness, D2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any swelling, D2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 swelling, D2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any pain, Across Doses
|
8 Participants
|
21 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 pain, Across Doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 redness, Across Doses
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Any swelling, Across Doses
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 1
Grade 3 swelling, Across Doses
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-placebo (PP) and post-vaccination period following each vaccine dose (D1 and D2) and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented, who have filled in their symptom sheets.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and /or abdominal pain\], headache, malaise, myalgia, shivering and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related headache, PP
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any malaise, PP
|
4 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any headache, PP
|
13 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related shivering, D2
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any temperature (≥37.5 °C), D2
|
1 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 temperature (> 39.5 °C), D2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 gastrointestinal symptoms, Across Doses
|
4 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 myalgia, Across Doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 temperature (> 39.5 °C), Across Doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related shivering, D1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any fatigue, PP
|
12 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 fatigue, PP
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related fatigue, PP
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any gastrointestinal symptoms, PP
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 gastrointestinal symptoms, PP
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related gastrointestinal symptoms, PP
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 headache, PP
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 malaise, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related malaise, PP
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any myalgia, PP
|
5 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 myalgia, PP
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related myalgia, PP
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any shivering, PP
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 shivering, PP
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related shivering, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any temperature, PP
|
2 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 temperature, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related temperature, PP
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any Fatigue, D1
|
6 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 fatigue, D1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related fatigue, D1
|
6 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any gastrointestinal symptoms, D1
|
6 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 gastrointestinal symptoms, D1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related gastrointestinal symptoms, D1
|
3 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any headache, D1
|
5 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 headache, D1
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related headache, D1
|
4 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any malaise, D1
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 malaise, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related malaise, D1
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any myalgia, D1
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 myalgia, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related temperature, Across Doses
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related myalgia, D1
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any shivering, D1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 shivering, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any temperature (≥37.5 °C), D1
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 temperature (> 39.5 °C), D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related temperature, D1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any Fatigue, D2
|
8 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 fatigue, D2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related fatigue, D2
|
7 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any gastrointestinal symptoms, D2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 gastrointestinal symptoms, D2
|
3 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related gastrointestinal symptoms, D2
|
5 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any headache, D2
|
5 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 headache, D2
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related headache, D2
|
5 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any malaise, D2
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 malaise, D2
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related malaise, D2
|
6 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any myalgia, D2
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 myalgia, D2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related myalgia, D2
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any shivering, D2
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 shivering, D2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related temperature, D2
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any Fatigue, Across Doses
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 fatigue, Across Doses
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related fatigue, Across Doses
|
9 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any gastrointestinal symptoms, Across Doses
|
8 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related gastrointestinal symptoms, Across Doses
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any headache, Across Doses
|
6 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 headache, Across Doses
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related headache, Across Doses
|
6 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any malaise, Across Doses
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 malaise, Across Doses
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related malaise, Across Doses
|
7 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any myalgia, Across Doses
|
2 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related myalgia, Across Doses
|
2 Participants
|
13 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any shivering, Across Doses
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Grade 3 shivering, Across Doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Related shivering, Across Doses
|
2 Participants
|
10 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 1
Any temperature (≥37.5 °C), Across Doses
|
2 Participants
|
6 Participants
|
SECONDARY outcome
Timeframe: Up to 4 days post-placebo/vaccine administration.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited symptoms were fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], pain, redness \[spreading beyond 20 millimeters (mm) of injection site\], induration \[spreading beyond 20 millimeters (mm) of injection site\], swelling \[spreading beyond 20 millimeters (mm) of injection site\] and muscle stiffness.
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Pain, placebo
|
4 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Pain, D1
|
9 Participants
|
19 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Redness, D1
|
1 Participants
|
8 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Induration, D2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Muscle stiffness, D1
|
5 Participants
|
14 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Fever (≥37.5), placebo
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Fever (≥37.5), D1
|
2 Participants
|
2 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Fever (≥37.5), D2
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Pain, D2
|
8 Participants
|
19 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Redness, placebo
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Redness, D2
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Induration, placebo
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Induration, D1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Swelling, placebo
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Swelling, D1
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Swelling, D2
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Muscle stiffness, placebo
|
2 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 1
Muscle stiffness, D2
|
4 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: Within the 28-day (Days 0-27) post-placebo (PP) and post-product administration period.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1
Any AEs, post-product administration
|
15 Participants
|
14 Participants
|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 1
Any AEs, post-placebo
|
16 Participants
|
12 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Step 1
Day 60 SAEs
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Serious Adverse Events (SAEs) - Step 1
Day 210 SAEs
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1
pIMDs - Day 60
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 1
pIMDs - Day 210
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: From Day 0 up to Day 60 for the HBsAg/AS_1 Group and from Day 0 up to Day 210 for the Engerix-B_1 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination. Analysis of intensity and relationship to vaccination of MAEs was not performed.
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1
MAEs - Day 60
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 1
MAEs - Day 210
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L). ALT levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1, Day 0
|
27 U/L
Interval 23.0 to 31.0
|
27.5 U/L
Interval 22.5 to 32.5
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1 (Day 0 H6)
|
26 U/L
Interval 22.0 to 34.0
|
26.5 U/L
Interval 22.0 to 33.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1 (Day 0 H12)
|
26 U/L
Interval 24.0 to 33.0
|
27 U/L
Interval 23.5 to 31.5
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1 (Day 0 H18)
|
24 U/L
Interval 16.0 to 48.0
|
28 U/L
Interval 25.0 to 35.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1, Day 1
|
27 U/L
Interval 20.0 to 35.0
|
25.5 U/L
Interval 20.0 to 33.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 1, Day 7
|
28 U/L
Interval 19.0 to 34.0
|
26.5 U/L
Interval 22.0 to 32.5
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2, Day 30
|
30 U/L
Interval 24.0 to 33.0
|
27 U/L
Interval 22.0 to 36.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2 (Day 30 H6)
|
28 U/L
Interval 25.0 to 32.0
|
27 U/L
Interval 23.0 to 34.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2 (Day 30 H12)
|
28 U/L
Interval 23.0 to 33.5
|
27 U/L
Interval 24.0 to 34.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2 (Day 30 H18)
|
26 U/L
Interval 24.0 to 46.0
|
32 U/L
Interval 25.0 to 37.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2, Day 31
|
27 U/L
Interval 23.0 to 34.0
|
27 U/L
Interval 22.0 to 33.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2, Day 37
|
26 U/L
Interval 23.5 to 33.0
|
27 U/L
Interval 22.0 to 30.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 1
ALT, Dose 2, Day 60
|
28 U/L
Interval 22.5 to 36.0
|
28 U/L
Interval 23.0 to 32.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L). AST levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2 (Day 30 H12)
|
21 U/L
Interval 20.0 to 24.5
|
20 U/L
Interval 18.0 to 25.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2 (Day 30 H18)
|
19.5 U/L
Interval 16.0 to 30.0
|
20 U/L
Interval 19.0 to 22.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2, Day 31
|
21 U/L
Interval 18.0 to 25.5
|
19 U/L
Interval 17.0 to 23.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2, Day 37
|
23 U/L
Interval 18.0 to 29.5
|
22 U/L
Interval 19.0 to 25.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1, Day 0
|
23 U/L
Interval 18.0 to 25.0
|
21 U/L
Interval 18.0 to 26.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1 (Day 0 H6)
|
21 U/L
Interval 17.0 to 25.0
|
20.5 U/L
Interval 18.5 to 24.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1 (Day 0 H12)
|
20 U/L
Interval 17.0 to 25.0
|
20 U/L
Interval 18.5 to 22.5
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1 (Day 0 H18)
|
18 U/L
Interval 17.0 to 28.0
|
19 U/L
Interval 15.0 to 24.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1, Day 1
|
20 U/L
Interval 18.0 to 23.0
|
19 U/L
Interval 16.0 to 22.5
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 1, Day 7
|
21 U/L
Interval 18.0 to 29.0
|
21 U/L
Interval 18.5 to 25.5
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2, Day 30
|
23 U/L
Interval 19.0 to 25.0
|
21 U/L
Interval 19.0 to 26.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2 (Day 30 H6)
|
22 U/L
Interval 20.0 to 25.5
|
21 U/L
Interval 19.0 to 24.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 1
AST, Dose 2, Day 60
|
21.5 U/L
Interval 18.0 to 28.5
|
21 U/L
Interval 18.0 to 26.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L). Basophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1, Day 0
|
0.02 billion cells/L
Interval 0.02 to 0.03
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1 (Day 0 H18)
|
0.02 billion cells/L
Interval 0.01 to 0.03
|
0.03 billion cells/L
Interval 0.01 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1 (Day 0 H6)
|
0.03 billion cells/L
Interval 0.02 to 0.03
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1 (Day 0 H12)
|
0.02 billion cells/L
Interval 0.02 to 0.03
|
0.03 billion cells/L
Interval 0.02 to 0.05
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1, Day 1
|
0.02 billion cells/L
Interval 0.02 to 0.03
|
0.03 billion cells/L
Interval 0.01 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 1, Day 7
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2, Day 30
|
0.02 billion cells/L
Interval 0.02 to 0.04
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2 (Day 30 H6)
|
0.02 billion cells/L
Interval 0.02 to 0.03
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2 (Day 30 H12)
|
0.02 billion cells/L
Interval 0.02 to 0.04
|
0.02 billion cells/L
Interval 0.01 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2 (Day 30 H18)
|
0.02 billion cells/L
Interval 0.01 to 0.03
|
0.03 billion cells/L
Interval 0.01 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2, Day 31
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.02 billion cells/L
Interval 0.01 to 0.03
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2, Day 37
|
0.03 billion cells/L
Interval 0.02 to 0.03
|
0.03 billion cells/L
Interval 0.02 to 0.06
|
|
Levels of Basophils in Blood Samples - Step 1
Basophils, Dose 2, Day 60
|
0.03 billion cells/L
Interval 0.02 to 0.03
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL). Bilirubin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2, Day 31
|
0.5 mg/dL
Interval 0.45 to 0.7
|
0.7 mg/dL
Interval 0.5 to 1.0
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2, Day 37
|
0.5 mg/dL
Interval 0.4 to 0.65
|
0.5 mg/dL
Interval 0.3 to 0.8
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1, Day 0
|
0.5 mg/dL
Interval 0.3 to 0.7
|
0.5 mg/dL
Interval 0.4 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1 (Day 0 H6)
|
0.4 mg/dL
Interval 0.3 to 0.5
|
0.4 mg/dL
Interval 0.25 to 0.5
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1 (Day 0 H12)
|
0.3 mg/dL
Interval 0.3 to 0.5
|
0.4 mg/dL
Interval 0.3 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1 (Day 0 H18)
|
0.5 mg/dL
Interval 0.3 to 0.6
|
0.6 mg/dL
Interval 0.4 to 0.8
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1, Day 1
|
0.5 mg/dL
Interval 0.3 to 0.8
|
0.7 mg/dL
Interval 0.6 to 0.9
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 1, Day 7
|
0.5 mg/dL
Interval 0.3 to 0.6
|
0.5 mg/dL
Interval 0.4 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2, Day 30
|
0.5 mg/dL
Interval 0.4 to 0.7
|
0.6 mg/dL
Interval 0.4 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2 (Day 30 H6)
|
0.4 mg/dL
Interval 0.3 to 0.5
|
0.4 mg/dL
Interval 0.3 to 0.5
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2 (Day 30 H12)
|
0.4 mg/dL
Interval 0.3 to 0.5
|
0.5 mg/dL
Interval 0.4 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2 (Day 30 H18)
|
0.45 mg/dL
Interval 0.3 to 0.5
|
0.6 mg/dL
Interval 0.4 to 0.7
|
|
Levels of Total Bilirubin in Blood Samples - Step 1
Total bilirubin, Dose 2, Day 60
|
0.5 mg/dL
Interval 0.4 to 0.6
|
0.5 mg/dL
Interval 0.4 to 0.6
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included creatinine levels. Creatinine concentrations were expressed in milligrams per deciliter (mg/dL). Creatinine levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1, Day 7
|
0.76 mg/dL
Interval 0.69 to 0.87
|
0.81 mg/dL
Interval 0.71 to 0.93
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2 (Day 30 H6)
|
0.73 mg/dL
Interval 0.67 to 0.83
|
0.75 mg/dL
Interval 0.68 to 0.85
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2 (Day 30 H12)
|
0.72 mg/dL
Interval 0.69 to 0.82
|
0.76 mg/dL
Interval 0.68 to 0.85
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1 (Day 0 H12)
|
0.73 mg/dL
Interval 0.68 to 0.83
|
0.78 mg/dL
Interval 0.66 to 0.83
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1 (Day 0 H18)
|
0.71 mg/dL
Interval 0.63 to 0.84
|
0.7 mg/dL
Interval 0.61 to 0.77
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1, Day 1
|
0.77 mg/dL
Interval 0.71 to 0.85
|
0.74 mg/dL
Interval 0.68 to 0.91
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2, Day 30
|
0.79 mg/dL
Interval 0.72 to 0.83
|
0.82 mg/dL
Interval 0.74 to 0.96
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2 (Day 30 H18)
|
0.73 mg/dL
Interval 0.65 to 0.82
|
0.74 mg/dL
Interval 0.68 to 0.81
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2, Day 31
|
0.76 mg/dL
Interval 0.7 to 0.87
|
0.79 mg/dL
Interval 0.69 to 0.93
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2, Day 37
|
0.73 mg/dL
Interval 0.7 to 0.9
|
0.81 mg/dL
Interval 0.73 to 0.93
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 2, Day 60
|
0.78 mg/dL
Interval 0.72 to 0.91
|
0.84 mg/dL
Interval 0.69 to 0.97
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1, Day 0
|
0.79 mg/dL
Interval 0.72 to 0.85
|
0.8 mg/dL
Interval 0.75 to 0.93
|
|
Levels of Serum Creatinine in Blood Samples - Step 1
Creatinine, Dose 1 (Day 0 H6)
|
0.72 mg/dL
Interval 0.69 to 0.82
|
0.75 mg/dL
Interval 0.66 to 0.85
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included CPK levels. CPK concentrations were expressed in milligrams per deciliter (mg/dL). CPK levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1 (Day 0 H18)
|
61 mg/dL
Interval 44.0 to 103.0
|
59 mg/dL
Interval 49.0 to 90.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1, Day 0
|
80 mg/dL
Interval 62.0 to 148.0
|
75 mg/dL
Interval 56.5 to 108.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1 (Day 0 H6
|
75 mg/dL
Interval 60.0 to 120.0
|
69.5 mg/dL
Interval 53.0 to 106.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1 (Day 0 H12)
|
77 mg/dL
Interval 57.0 to 110.0
|
64.5 mg/dL
Interval 51.0 to 94.5
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1, Day 1
|
69 mg/dL
Interval 46.0 to 96.0
|
54 mg/dL
Interval 42.5 to 79.5
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 1, Day 7
|
80 mg/dL
Interval 57.0 to 117.0
|
66 mg/dL
Interval 55.5 to 95.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2, Day 30
|
87 mg/dL
Interval 55.0 to 145.0
|
83 mg/dL
Interval 48.0 to 122.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2 (Day 30 H6)
|
86 mg/dL
Interval 53.5 to 140.5
|
81 mg/dL
Interval 45.0 to 108.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2 (Day 30 H12)
|
80.5 mg/dL
Interval 54.0 to 134.0
|
72 mg/dL
Interval 50.0 to 98.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2 (Day 30 H18)
|
70 mg/dL
Interval 37.0 to 120.0
|
68.5 mg/dL
Interval 53.0 to 103.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2, Day 31
|
75 mg/dL
Interval 50.0 to 119.0
|
67 mg/dL
Interval 44.0 to 87.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2, Day 37
|
93.5 mg/dL
Interval 54.0 to 115.5
|
83 mg/dL
Interval 59.0 to 119.0
|
|
Levels of Creatinine Phosphokinase (CPK) in Blood Samples - Step 1
CPK, Dose 2, Day 60
|
82.5 mg/dL
Interval 62.0 to 122.0
|
82 mg/dL
Interval 55.0 to 118.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L). CRP levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2 (Day 30 H18)
|
0.75 mg/L
Interval 0.5 to 2.8
|
3.15 mg/L
Interval 2.1 to 5.3
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2, Day 31
|
1.2 mg/L
Interval 0.5 to 2.65
|
5.8 mg/L
Interval 2.6 to 14.5
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1, Day 0
|
1.7 mg/L
Interval 0.5 to 2.5
|
1.15 mg/L
Interval 0.5 to 3.0
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1 (Day 0 H6)
|
1.6 mg/L
Interval 0.5 to 2.4
|
0.8 mg/L
Interval 0.5 to 2.9
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1 (Day 0 H12)
|
1.4 mg/L
Interval 0.5 to 2.1
|
1.5 mg/L
Interval 0.5 to 3.35
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1 (Day 0 H18)
|
1.25 mg/L
Interval 0.5 to 1.8
|
2.9 mg/L
Interval 1.5 to 4.4
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1, Day 1
|
1.2 mg/L
Interval 0.5 to 1.8
|
5.8 mg/L
Interval 3.1 to 11.1
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 1, Day 7
|
1.3 mg/L
Interval 0.5 to 2.6
|
1.9 mg/L
Interval 0.5 to 4.25
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2, Day 30
|
1.4 mg/L
Interval 0.5 to 3.1
|
1.3 mg/L
Interval 0.5 to 4.3
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2 (Day 30 H6)
|
1.5 mg/L
Interval 0.5 to 3.05
|
1.2 mg/L
Interval 0.5 to 2.3
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2 (Day 30 H12)
|
1.55 mg/L
Interval 0.5 to 3.1
|
1.8 mg/L
Interval 0.5 to 2.8
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2, Day 37
|
1.3 mg/L
Interval 0.5 to 2.95
|
2.1 mg/L
Interval 1.1 to 5.8
|
|
Levels of C-reactive Protein (CRP) in Blood Samples - Step 1
CRP, Dose 2, Day 60
|
1.05 mg/L
Interval 0.5 to 3.85
|
1.4 mg/L
Interval 0.5 to 3.9
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L). Eosinophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2 (Day 30 H6)
|
0.13 billion cells/L
Interval 0.09 to 0.22
|
0.18 billion cells/L
Interval 0.1 to 0.29
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2, Day 37
|
0.15 billion cells/L
Interval 0.09 to 0.23
|
0.19 billion cells/L
Interval 0.11 to 0.24
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1, Day 0
|
0.13 billion cells/L
Interval 0.1 to 0.21
|
0.2 billion cells/L
Interval 0.11 to 0.25
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1 (Day 0 H6)
|
0.13 billion cells/L
Interval 0.09 to 0.21
|
0.19 billion cells/L
Interval 0.13 to 0.27
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1 (Day 0 H12)
|
0.17 billion cells/L
Interval 0.12 to 0.21
|
0.21 billion cells/L
Interval 0.15 to 0.27
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1 (Day 0 H18)
|
0.2 billion cells/L
Interval 0.16 to 0.31
|
0.16 billion cells/L
Interval 0.12 to 0.3
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1, Day 1
|
0.1 billion cells/L
Interval 0.07 to 0.2
|
0.15 billion cells/L
Interval 0.08 to 0.25
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 1, Day 7
|
0.11 billion cells/L
Interval 0.09 to 0.17
|
0.14 billion cells/L
Interval 0.08 to 0.2
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2, Day 30
|
0.14 billion cells/L
Interval 0.09 to 0.26
|
0.18 billion cells/L
Interval 0.11 to 0.25
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2 (Day 30 H12)
|
0.14 billion cells/L
Interval 0.09 to 0.24
|
0.19 billion cells/L
Interval 0.12 to 0.31
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2 (Day 30 H18)
|
0.19 billion cells/L
Interval 0.12 to 0.32
|
0.14 billion cells/L
Interval 0.05 to 0.21
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2, Day 31
|
0.13 billion cells/L
Interval 0.09 to 0.22
|
0.14 billion cells/L
Interval 0.05 to 0.2
|
|
Levels of Eosinophils in Blood Samples - Step 1
Eosinophils, Dose 2, Day 60
|
0.14 billion cells/L
Interval 0.11 to 0.24
|
0.19 billion cells/L
Interval 0.1 to 0.28
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included haemoglobin levels, expressed in grams per deciliter (g/dL). Haemoglobin levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2 (Day 30 H6)
|
13.55 g/dL
Interval 12.45 to 14.15
|
13.4 g/dL
Interval 12.5 to 14.0
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1, Day 0
|
13.8 g/dL
Interval 12.5 to 14.8
|
13.35 g/dL
Interval 12.7 to 14.5
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1 (Day 0 H6)
|
13.6 g/dL
Interval 12.5 to 14.6
|
13.45 g/dL
Interval 12.3 to 14.05
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1 (Day 0 H12)
|
13.2 g/dL
Interval 12.6 to 14.5
|
13.25 g/dL
Interval 12.3 to 14.3
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1 (Day 0 H18)
|
13.15 g/dL
Interval 12.5 to 14.5
|
12.6 g/dL
Interval 12.0 to 13.9
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1, Day 1
|
13.8 g/dL
Interval 12.9 to 14.7
|
13.5 g/dL
Interval 12.6 to 14.45
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 1, Day 7
|
13.8 g/dL
Interval 12.8 to 14.6
|
13.35 g/dL
Interval 12.55 to 14.35
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2, Day 30
|
13.4 g/dL
Interval 12.6 to 14.3
|
13.7 g/dL
Interval 12.7 to 14.3
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2 (Day 30 H12)
|
13.1 g/dL
Interval 12.4 to 14.15
|
13.2 g/dL
Interval 12.6 to 14.1
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2 (Day 30 H18)
|
13.05 g/dL
Interval 12.3 to 14.1
|
13.15 g/dL
Interval 11.7 to 13.9
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2, Day 31
|
13.75 g/dL
Interval 12.65 to 14.6
|
13.5 g/dL
Interval 12.5 to 14.4
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2, Day 37
|
13.65 g/dL
Interval 12.35 to 14.5
|
13.6 g/dL
Interval 12.6 to 14.5
|
|
Levels of Haemoglobin in Blood Samples - Step 1
Haemoglobin, Dose 2, Day 60
|
13.8 g/dL
Interval 12.2 to 14.5
|
13.5 g/dL
Interval 12.4 to 14.5
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included LDH levels, expressed in units per liter (U/L). LDH levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2 (Day 30 H6)
|
396.5 U/L
Interval 350.5 to 428.0
|
437 U/L
Interval 397.0 to 470.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2 (Day 30 H12)
|
382.5 U/L
Interval 338.5 to 424.0
|
425 U/L
Interval 403.0 to 470.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1, Day 0
|
382 U/L
Interval 346.0 to 438.0
|
401.5 U/L
Interval 377.0 to 473.5
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1 (Day 0 H6)
|
389 U/L
Interval 353.0 to 423.0
|
414 U/L
Interval 388.5 to 449.5
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1 (Day 0 H12)
|
378 U/L
Interval 339.0 to 426.0
|
412 U/L
Interval 392.0 to 457.5
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1 (Day 0 H18)
|
369.5 U/L
Interval 302.0 to 410.0
|
422 U/L
Interval 341.0 to 461.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1, Day 1
|
367 U/L
Interval 342.0 to 411.0
|
389 U/L
Interval 352.0 to 466.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 1, Day 7
|
392 U/L
Interval 371.0 to 436.0
|
417.5 U/L
Interval 382.5 to 479.5
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2, Day 30
|
395 U/L
Interval 348.0 to 426.0
|
391 U/L
Interval 360.0 to 456.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2 (Day 30 H18)
|
334.5 U/L
Interval 297.0 to 390.0
|
403 U/L
Interval 365.0 to 450.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2, Day 31
|
372 U/L
Interval 354.0 to 403.0
|
408 U/L
Interval 373.0 to 453.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2, Day 37
|
403 U/L
Interval 368.5 to 446.0
|
442 U/L
Interval 412.0 to 464.0
|
|
Levels of Lactate Dehydrogenase (LDH) in Blood Samples - Step 1
LDH, Dose 2, Day 60
|
404 U/L
Interval 374.0 to 431.5
|
422 U/L
Interval 397.0 to 478.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L). Lymphocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1 (Day 0 H18)
|
3.08 billion cells/L
Interval 2.45 to 3.53
|
1.73 billion cells/L
Interval 1.41 to 2.48
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1, Day 0
|
1.99 billion cells/L
Interval 1.61 to 2.26
|
1.84 billion cells/L
Interval 1.45 to 1.98
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1 (Day 0 H6)
|
2.07 billion cells/L
Interval 1.52 to 2.46
|
1.89 billion cells/L
Interval 1.48 to 2.35
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1 (Day 0 H12)
|
2.39 billion cells/L
Interval 2.0 to 2.97
|
1.97 billion cells/L
Interval 1.72 to 2.33
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1, Day 1
|
1.94 billion cells/L
Interval 1.66 to 2.26
|
1.58 billion cells/L
Interval 1.25 to 1.83
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 1, Day 7
|
1.97 billion cells/L
Interval 1.56 to 2.17
|
1.69 billion cells/L
Interval 1.37 to 1.91
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2, Day 30
|
1.97 billion cells/L
Interval 1.64 to 2.5
|
1.67 billion cells/L
Interval 1.36 to 2.03
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2 (Day 30 H6)
|
2.11 billion cells/L
Interval 1.78 to 2.59
|
1.81 billion cells/L
Interval 1.56 to 2.16
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2 (Day 30 H12)
|
2.35 billion cells/L
Interval 2.1 to 2.82
|
1.9 billion cells/L
Interval 1.36 to 2.39
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2 (Day 30 H18)
|
2.99 billion cells/L
Interval 2.45 to 3.53
|
1.46 billion cells/L
Interval 1.06 to 1.83
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2, Day 31
|
2.01 billion cells/L
Interval 1.75 to 2.5
|
1.19 billion cells/L
Interval 0.89 to 1.43
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2, Day 37
|
2.01 billion cells/L
Interval 1.64 to 2.36
|
1.74 billion cells/L
Interval 1.41 to 2.21
|
|
Levels of Lymphocytes in Blood Samples - Step 1
Lymphocytes, Dose 2, Day 60
|
2.09 billion cells/L
Interval 1.73 to 2.31
|
1.76 billion cells/L
Interval 1.4 to 2.29
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L). Monocyte levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2 (Day 30 H18)
|
0.49 billion cells/L
Interval 0.43 to 0.59
|
0.8 billion cells/L
Interval 0.62 to 0.94
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2, Day 37
|
0.51 billion cells/L
Interval 0.44 to 0.59
|
0.51 billion cells/L
Interval 0.39 to 0.64
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2 (Day 30 H12)
|
0.51 billion cells/L
Interval 0.39 to 0.61
|
0.66 billion cells/L
Interval 0.57 to 0.87
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2, Day 31
|
0.51 billion cells/L
Interval 0.44 to 0.67
|
0.67 billion cells/L
Interval 0.53 to 0.81
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2, Day 60
|
0.52 billion cells/L
Interval 0.44 to 0.64
|
0.51 billion cells/L
Interval 0.39 to 0.68
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1, Day 0
|
0.55 billion cells/L
Interval 0.4 to 0.62
|
0.55 billion cells/L
Interval 0.45 to 0.66
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1 (Day 0 H6)
|
0.52 billion cells/L
Interval 0.4 to 0.55
|
0.67 billion cells/L
Interval 0.59 to 0.76
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1 (Day 0 H12)
|
0.53 billion cells/L
Interval 0.41 to 0.6
|
0.79 billion cells/L
Interval 0.62 to 0.9
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1 (Day 0 H18)
|
0.59 billion cells/L
Interval 0.5 to 0.61
|
0.79 billion cells/L
Interval 0.66 to 0.92
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1, Day 1
|
0.45 billion cells/L
Interval 0.4 to 0.54
|
0.72 billion cells/L
Interval 0.6 to 0.84
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 1, Day 7
|
0.44 billion cells/L
Interval 0.37 to 0.58
|
0.54 billion cells/L
Interval 0.43 to 0.63
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2, Day 30
|
0.5 billion cells/L
Interval 0.43 to 0.63
|
0.55 billion cells/L
Interval 0.47 to 0.65
|
|
Levels of Monocytes in Blood Samples - Step 1
Monocytes, Dose 2 (Day 30 H6)
|
0.48 billion cells/L
Interval 0.4 to 0.56
|
0.67 billion cells/L
Interval 0.54 to 0.78
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L). Neutrophil levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1, Day 0
|
3.36 billion cells/L
Interval 2.77 to 4.21
|
3.7 billion cells/L
Interval 3.0 to 5.49
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1 (Day 0 H6)
|
4.12 billion cells/L
Interval 2.96 to 4.41
|
6.48 billion cells/L
Interval 5.02 to 7.84
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1 (Day 0 H12)
|
3.39 billion cells/L
Interval 3.0 to 4.53
|
7.61 billion cells/L
Interval 6.87 to 9.01
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1 (Day 0 H18)
|
3.61 billion cells/L
Interval 3.31 to 4.12
|
6.07 billion cells/L
Interval 5.56 to 8.31
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1, Day 1
|
3.76 billion cells/L
Interval 3.12 to 4.23
|
6.13 billion cells/L
Interval 4.26 to 6.76
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 1, Day 7
|
3.46 billion cells/L
Interval 2.73 to 4.19
|
4.17 billion cells/L
Interval 3.05 to 5.17
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2, Day 30
|
2.91 billion cells/L
Interval 2.43 to 3.91
|
3.66 billion cells/L
Interval 3.08 to 4.49
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2 (Day 30 H6)
|
3.39 billion cells/L
Interval 2.93 to 4.07
|
5.9 billion cells/L
Interval 5.28 to 7.75
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2 (Day 30 H12)
|
3.36 billion cells/L
Interval 2.59 to 4.12
|
7.07 billion cells/L
Interval 6.47 to 8.58
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2 (Day 30 H18)
|
3.02 billion cells/L
Interval 2.39 to 3.74
|
7.42 billion cells/L
Interval 6.84 to 9.35
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2, Day 31
|
3.2 billion cells/L
Interval 2.77 to 4.9
|
6.32 billion cells/L
Interval 4.78 to 7.41
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2, Day 37
|
3.13 billion cells/L
Interval 2.68 to 4.47
|
3.64 billion cells/L
Interval 2.73 to 5.48
|
|
Levels of Neutrophils in Blood Samples - Step 1
Neutrophils, Dose 2, Day 60
|
2.95 billion cells/L
Interval 2.5 to 3.71
|
3.96 billion cells/L
Interval 3.16 to 4.96
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L). Platelet count levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2, Day 30
|
228 billion cells/L
Interval 204.0 to 260.0
|
224 billion cells/L
Interval 185.0 to 267.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1, Day 0
|
225 billion cells/L
Interval 207.0 to 266.0
|
228 billion cells/L
Interval 191.5 to 261.5
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1 (Day 0 H6)
|
231 billion cells/L
Interval 212.0 to 263.0
|
229 billion cells/L
Interval 204.0 to 259.5
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1 (Day 0 H12)
|
230 billion cells/L
Interval 217.0 to 263.0
|
235 billion cells/L
Interval 193.0 to 259.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1 (Day 0 H18)
|
233 billion cells/L
Interval 215.0 to 274.0
|
222 billion cells/L
Interval 186.0 to 260.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1, Day 1
|
227 billion cells/L
Interval 206.0 to 269.0
|
220.5 billion cells/L
Interval 187.5 to 258.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 1, Day 7
|
247 billion cells/L
Interval 217.0 to 268.0
|
263.5 billion cells/L
Interval 215.5 to 291.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2 (Day 30 H6)
|
232 billion cells/L
Interval 212.0 to 261.5
|
238 billion cells/L
Interval 195.0 to 270.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2 (Day 30 H12)
|
234 billion cells/L
Interval 213.5 to 258.0
|
226 billion cells/L
Interval 194.0 to 260.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2 (Day 30 H18)
|
229 billion cells/L
Interval 199.0 to 275.0
|
230.5 billion cells/L
Interval 179.0 to 276.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2, Day 31
|
217.5 billion cells/L
Interval 204.5 to 256.5
|
218 billion cells/L
Interval 170.0 to 238.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2, Day 37
|
243 billion cells/L
Interval 208.5 to 282.0
|
253 billion cells/L
Interval 205.0 to 301.0
|
|
Platelet Count in Blood Samples - Step 1
Platelets, Dose 2, Day 60
|
241.5 billion cells/L
Interval 208.0 to 276.5
|
240 billion cells/L
Interval 195.0 to 283.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included red blood cells levels, expressed in trillion cells per liter (trillion cells/L). RBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2, Day 31
|
4.58 trillion cells/L
Interval 4.38 to 4.9
|
4.42 trillion cells/L
Interval 4.12 to 4.85
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2, Day 37
|
4.52 trillion cells/L
Interval 4.2 to 4.88
|
4.5 trillion cells/L
Interval 4.13 to 4.84
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1, Day 0
|
4.56 trillion cells/L
Interval 4.27 to 4.96
|
4.51 trillion cells/L
Interval 4.33 to 4.83
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1 (Day 0 H6)
|
4.58 trillion cells/L
Interval 4.24 to 4.78
|
4.45 trillion cells/L
Interval 4.18 to 4.82
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1 (Day 0 H12)
|
4.51 trillion cells/L
Interval 4.27 to 4.78
|
4.42 trillion cells/L
Interval 4.12 to 4.68
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1 (Day 0 H18)
|
4.36 trillion cells/L
Interval 4.19 to 4.72
|
4.19 trillion cells/L
Interval 4.02 to 4.79
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1, Day 1
|
4.62 trillion cells/L
Interval 4.36 to 4.78
|
4.48 trillion cells/L
Interval 4.25 to 4.85
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 1, Day 7
|
4.54 trillion cells/L
Interval 4.38 to 4.92
|
4.54 trillion cells/L
Interval 4.24 to 4.75
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2, Day 30
|
4.53 trillion cells/L
Interval 4.25 to 4.79
|
4.48 trillion cells/L
Interval 4.27 to 4.7
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2 (Day 30 H6)
|
4.49 trillion cells/L
Interval 4.26 to 4.8
|
4.43 trillion cells/L
Interval 4.14 to 4.6
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2 (Day 30 H12)
|
4.46 trillion cells/L
Interval 4.25 to 4.71
|
4.33 trillion cells/L
Interval 4.21 to 4.62
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2 (Day 30 H18)
|
4.34 trillion cells/L
Interval 4.09 to 4.62
|
4.22 trillion cells/L
Interval 3.86 to 4.66
|
|
Levels of Red Blood Cell (RBC) in Blood Samples - Step 1
RBC, Dose 2, Day 60
|
4.61 trillion cells/L
Interval 4.41 to 4.85
|
4.5 trillion cells/L
Interval 4.14 to 4.94
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included urea levels, expressed in miligrams per deciliter (mg/dL). Urea levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1, Day 0
|
30 mg/dL
Interval 26.0 to 35.0
|
27.5 mg/dL
Interval 23.0 to 35.5
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1 (Day 0 H6)
|
30 mg/dL
Interval 26.0 to 34.0
|
27 mg/dL
Interval 24.0 to 31.5
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1 (Day 0 H12)
|
29 mg/dL
Interval 27.0 to 32.0
|
27 mg/dL
Interval 24.0 to 31.5
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1 (Day 0 H18)
|
27 mg/dL
Interval 24.0 to 30.0
|
23 mg/dL
Interval 21.0 to 32.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1, Day 1
|
25 mg/dL
Interval 23.0 to 30.0
|
23.5 mg/dL
Interval 18.5 to 29.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 1, Day 7
|
27 mg/dL
Interval 23.0 to 31.0
|
27.5 mg/dL
Interval 24.5 to 35.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2, Day 30
|
26 mg/dL
Interval 22.0 to 33.0
|
28 mg/dL
Interval 25.0 to 37.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2 (Day 30 H6)
|
26 mg/dL
Interval 23.0 to 32.5
|
29 mg/dL
Interval 24.0 to 34.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2 (Day 30 H12)
|
27 mg/dL
Interval 23.5 to 32.0
|
28 mg/dL
Interval 24.0 to 34.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2 (Day 30 H18)
|
24.5 mg/dL
Interval 22.0 to 28.0
|
25.5 mg/dL
Interval 21.0 to 31.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2, Day 31
|
26 mg/dL
Interval 21.0 to 28.5
|
23 mg/dL
Interval 19.0 to 30.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2, Day 37
|
25.5 mg/dL
Interval 23.0 to 31.0
|
26 mg/dL
Interval 22.0 to 36.0
|
|
Levels of Urea in Blood Samples - Step 1
Urea Nitrogen, Dose 2, Day 60
|
27 mg/dL
Interval 23.5 to 30.0
|
29 mg/dL
Interval 22.0 to 33.0
|
SECONDARY outcome
Timeframe: At Day 0, Day 0 H6, Day 0 H12, Day 0 H18, Day 1, Day 7, Day 30, Day 30 H6, Day 30 H12, Day 30 H18, Day 31, Day 37 and Day 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included WBC levels. WBC levels were expressed in billion cells per liter (billion cells/L). WBC levels were assessed at different time points (plus 6, 12 and 18 hours - H6, H12, H18) on Day 0 and Day 30.
Outcome measures
| Measure |
Engerix-B_1 Group
n=29 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=28 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1, Day 0
|
6.33 billion cells/L
Interval 5.46 to 7.03
|
6.25 billion cells/L
Interval 5.53 to 8.49
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1 (Day 0 H6)
|
6.49 billion cells/L
Interval 5.78 to 7.37
|
9.73 billion cells/L
Interval 7.7 to 11.3
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1 (Day 0 H12)
|
6.84 billion cells/L
Interval 6.0 to 7.4
|
10.45 billion cells/L
Interval 9.75 to 12.4
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1 (Day 0 H18)
|
7.43 billion cells/L
Interval 7.15 to 8.02
|
8.72 billion cells/L
Interval 7.63 to 12.2
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1, Day 1
|
6.25 billion cells/L
Interval 5.85 to 6.83
|
8.7 billion cells/L
Interval 6.37 to 9.7
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 1, Day 7
|
6.14 billion cells/L
Interval 5.27 to 7.32
|
6.67 billion cells/L
Interval 5.49 to 8.17
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2, Day 30
|
5.77 billion cells/L
Interval 4.96 to 7.21
|
6.04 billion cells/L
Interval 5.48 to 8.07
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2 (Day 30 H6)
|
6.07 billion cells/L
Interval 5.76 to 6.96
|
9.28 billion cells/L
Interval 7.91 to 10.4
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2 (Day 30 H12)
|
6.28 billion cells/L
Interval 5.8 to 7.37
|
9.88 billion cells/L
Interval 9.29 to 11.4
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2 (Day 30 H18)
|
6.8 billion cells/L
Interval 6.49 to 7.21
|
9.57 billion cells/L
Interval 8.24 to 12.2
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2, Day 31
|
6.34 billion cells/L
Interval 5.67 to 7.16
|
8.21 billion cells/L
Interval 6.78 to 9.36
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2, Day 37
|
6.25 billion cells/L
Interval 5.46 to 7.31
|
5.7 billion cells/L
Interval 5.13 to 8.46
|
|
Levels of White Blood Cells (WBC) - Step 1
WBC, Dose 2, Day 60
|
6.07 billion cells/L
Interval 5.04 to 6.7
|
6.48 billion cells/L
Interval 5.45 to 8.24
|
SECONDARY outcome
Timeframe: At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, diastolic blood pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30)
|
76.5 mmHg
Interval 67.0 to 83.0
|
81 mmHg
Interval 74.0 to 86.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H1.5)
|
72 mmHg
Interval 65.0 to 79.0
|
75 mmHg
Interval 69.0 to 83.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H3)
|
71.5 mmHg
Interval 65.0 to 80.0
|
75.5 mmHg
Interval 68.0 to 83.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H6)
|
71.5 mmHg
Interval 67.0 to 82.0
|
73.5 mmHg
Interval 67.0 to 83.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H9)
|
75 mmHg
Interval 67.0 to 84.0
|
76 mmHg
Interval 71.0 to 86.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H12)
|
72.5 mmHg
Interval 66.0 to 80.0
|
78 mmHg
Interval 69.0 to 84.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-30 H18)
|
68 mmHg
Interval 64.0 to 84.0
|
75 mmHg
Interval 67.0 to 80.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-29)
|
73.5 mmHg
Interval 64.0 to 81.0
|
77 mmHg
Interval 70.0 to 83.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-28)
|
74.5 mmHg
Interval 69.0 to 78.0
|
75 mmHg
Interval 70.0 to 83.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-27)
|
75 mmHg
Interval 71.0 to 81.0
|
78 mmHg
Interval 72.0 to 82.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, placebo (D-23)
|
75.5 mmHg
Interval 66.0 to 80.0
|
76 mmHg
Interval 71.0 to 81.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0)
|
76 mmHg
Interval 68.0 to 85.0
|
76 mmHg
Interval 70.5 to 83.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0 H1.5)
|
73 mmHg
Interval 67.0 to 78.0
|
74 mmHg
Interval 70.0 to 81.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0 H6)
|
72 mmHg
Interval 65.0 to 78.0
|
73.5 mmHg
Interval 67.5 to 80.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0 H12)
|
72 mmHg
Interval 66.0 to 79.0
|
72 mmHg
Interval 69.0 to 79.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D0 H18)
|
66.5 mmHg
Interval 60.0 to 78.0
|
73 mmHg
Interval 61.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D1)
|
76 mmHg
Interval 66.0 to 80.0
|
72 mmHg
Interval 69.0 to 79.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D2)
|
73 mmHg
Interval 67.0 to 79.0
|
74 mmHg
Interval 70.0 to 81.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 1 (D7)
|
73 mmHg
Interval 70.0 to 82.0
|
75 mmHg
Interval 71.0 to 79.5
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30)
|
77.5 mmHg
Interval 68.5 to 83.0
|
76 mmHg
Interval 69.0 to 80.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H1.5)
|
70 mmHg
Interval 66.0 to 76.5
|
72 mmHg
Interval 67.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H3)
|
72 mmHg
Interval 63.0 to 78.0
|
72 mmHg
Interval 68.0 to 79.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H6)
|
70.5 mmHg
Interval 65.5 to 75.5
|
72 mmHg
Interval 69.0 to 75.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H9)
|
75 mmHg
Interval 65.5 to 81.5
|
75 mmHg
Interval 71.0 to 79.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H12)
|
72.5 mmHg
Interval 66.5 to 79.5
|
73 mmHg
Interval 68.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D30 H18)
|
71.5 mmHg
Interval 66.0 to 79.0
|
70 mmHg
Interval 64.0 to 74.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D31)
|
71 mmHg
Interval 65.5 to 80.0
|
71 mmHg
Interval 67.0 to 77.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D32)
|
74 mmHg
Interval 67.0 to 79.0
|
77 mmHg
Interval 71.0 to 81.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D33)
|
73 mmHg
Interval 70.5 to 79.5
|
77 mmHg
Interval 71.0 to 81.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D37)
|
74 mmHg
Interval 68.5 to 79.5
|
76 mmHg
Interval 68.0 to 86.0
|
|
Levels of Diastolic Blood Pressure - Step 1
Diastolic, Dose 2 (D60)
|
73 mmHg
Interval 67.0 to 81.5
|
78 mmHg
Interval 72.0 to 84.0
|
SECONDARY outcome
Timeframe: At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Heart rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed in beats per minute. On Days -30, 0 and 30, heart rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H18)
|
70 beats/minute
Interval 66.0 to 77.0
|
66 beats/minute
Interval 55.0 to 75.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30)
|
70 beats/minute
Interval 64.0 to 79.0
|
75.5 beats/minute
Interval 62.0 to 86.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H1.5)
|
73 beats/minute
Interval 62.0 to 77.0
|
75 beats/minute
Interval 62.0 to 82.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H3)
|
63.5 beats/minute
Interval 58.0 to 71.0
|
69.5 beats/minute
Interval 56.0 to 76.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H6)
|
69 beats/minute
Interval 60.0 to 80.0
|
69 beats/minute
Interval 61.0 to 78.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H9)
|
65 beats/minute
Interval 55.0 to 70.0
|
66.5 beats/minute
Interval 56.0 to 82.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-30 H12)
|
72.5 beats/minute
Interval 60.0 to 81.0
|
71.5 beats/minute
Interval 64.0 to 80.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-29)
|
65.5 beats/minute
Interval 62.0 to 70.0
|
74.5 beats/minute
Interval 63.0 to 82.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-28)
|
73.5 beats/minute
Interval 65.0 to 81.0
|
70 beats/minute
Interval 66.0 to 82.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-27)
|
70 beats/minute
Interval 65.0 to 81.0
|
72 beats/minute
Interval 66.0 to 80.0
|
|
Levels of Heart Rate - Step 1
Heart rate, placebo (D-23)
|
66 beats/minute
Interval 58.0 to 75.0
|
72 beats/minute
Interval 66.0 to 80.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0)
|
72 beats/minute
Interval 62.0 to 79.0
|
69.5 beats/minute
Interval 62.0 to 80.5
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0 H1.5)
|
68 beats/minute
Interval 62.0 to 77.0
|
67.5 beats/minute
Interval 62.0 to 76.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0 H6)
|
68 beats/minute
Interval 65.0 to 79.0
|
66 beats/minute
Interval 60.5 to 80.5
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0 H12)
|
69 beats/minute
Interval 61.0 to 79.0
|
76 beats/minute
Interval 66.5 to 83.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D0 H18)
|
67 beats/minute
Interval 60.0 to 77.0
|
76 beats/minute
Interval 60.0 to 83.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D1)
|
67 beats/minute
Interval 64.0 to 75.0
|
72 beats/minute
Interval 65.0 to 82.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D2)
|
69 beats/minute
Interval 65.0 to 79.0
|
71.5 beats/minute
Interval 60.0 to 80.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 1 (D7)
|
71 beats/minute
Interval 62.0 to 82.0
|
74 beats/minute
Interval 63.0 to 80.5
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30)
|
66.5 beats/minute
Interval 58.0 to 76.5
|
65 beats/minute
Interval 59.0 to 77.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H1.5)
|
68.5 beats/minute
Interval 57.5 to 79.0
|
69 beats/minute
Interval 60.0 to 78.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H3)
|
65 beats/minute
Interval 60.5 to 76.0
|
66 beats/minute
Interval 55.0 to 74.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H6)
|
71.5 beats/minute
Interval 62.5 to 81.0
|
73 beats/minute
Interval 64.0 to 80.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H9)
|
65.5 beats/minute
Interval 59.0 to 79.0
|
72 beats/minute
Interval 57.0 to 81.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H12)
|
69.5 beats/minute
Interval 63.0 to 81.0
|
79 beats/minute
Interval 66.0 to 85.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D30 H18)
|
74.5 beats/minute
Interval 66.0 to 80.0
|
84.5 beats/minute
Interval 79.0 to 90.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D31)
|
66.5 beats/minute
Interval 58.0 to 77.5
|
81 beats/minute
Interval 65.0 to 89.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D32)
|
70.5 beats/minute
Interval 62.0 to 77.5
|
70 beats/minute
Interval 63.0 to 83.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D33)
|
70.5 beats/minute
Interval 64.5 to 79.0
|
69 beats/minute
Interval 63.0 to 81.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D37)
|
72.5 beats/minute
Interval 61.5 to 79.5
|
67 beats/minute
Interval 59.0 to 79.0
|
|
Levels of Heart Rate - Step 1
Heart rate, Dose 2 (D60)
|
71 beats/minute
Interval 63.5 to 79.5
|
72 beats/minute
Interval 67.0 to 80.0
|
SECONDARY outcome
Timeframe: At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Respiratory Rate was part of the list of vital signs followed at specific protocol-defined timepoints during this study. It was expressed as breaths per minute (breaths/min). On Days -30, 0 and 30, respiratory rate was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30)
|
13 breaths/min
Interval 12.0 to 16.0
|
14 breaths/min
Interval 12.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H1.5)
|
14.5 breaths/min
Interval 13.0 to 16.0
|
13 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H3)
|
14 breaths/min
Interval 12.0 to 15.0
|
13 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H6)
|
14 breaths/min
Interval 13.0 to 16.0
|
12.5 breaths/min
Interval 12.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H9)
|
15 breaths/min
Interval 13.0 to 16.0
|
13 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H12)
|
14.5 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-30 H18)
|
12 breaths/min
Interval 11.0 to 14.0
|
13 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-29)
|
14 breaths/min
Interval 13.0 to 15.0
|
13.5 breaths/min
Interval 12.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-28)
|
14 breaths/min
Interval 13.0 to 16.0
|
14 breaths/min
Interval 12.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-27)
|
14 breaths/min
Interval 13.0 to 14.0
|
14 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, placebo (D-23)
|
14 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 12.5 to 15.5
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0 H1.5)
|
14 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0 H6)
|
14 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0 H12)
|
14 breaths/min
Interval 13.0 to 14.0
|
13.5 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D0 H18)
|
14 breaths/min
Interval 13.0 to 15.0
|
13 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D1)
|
14 breaths/min
Interval 13.0 to 14.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D2)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 13.0 to 14.5
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 1 (D7)
|
13 breaths/min
Interval 13.0 to 14.0
|
13.5 breaths/min
Interval 13.0 to 14.5
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30)
|
14 breaths/min
Interval 12.0 to 16.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H1.5)
|
14 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 13.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H3)
|
14 breaths/min
Interval 12.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H6)
|
14 breaths/min
Interval 12.0 to 15.0
|
13 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H9)
|
13.5 breaths/min
Interval 12.5 to 14.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H12)
|
14 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D30 H18)
|
14 breaths/min
Interval 14.0 to 15.0
|
14 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D31)
|
14 breaths/min
Interval 12.0 to 15.0
|
13 breaths/min
Interval 12.0 to 15.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D32)
|
14 breaths/min
Interval 13.0 to 15.0
|
14 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D33)
|
14 breaths/min
Interval 13.0 to 15.0
|
13 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D37)
|
14 breaths/min
Interval 12.5 to 15.0
|
14 breaths/min
Interval 12.0 to 16.0
|
|
Levels of Respiratory Rate - Step 1
Respiratory Rate, Dose 2 (D60)
|
14 breaths/min
Interval 13.0 to 16.0
|
14 breaths/min
Interval 12.0 to 15.0
|
SECONDARY outcome
Timeframe: At Day -30, -30 (H1.5, H3, H6, H9, H12, H18) -29, - 28, - 27, -23, 0, 0 (H1.5, H6, H12 H18), 1, 2, 7, 30, 30 (H1.5, H3, H6, H9, H12, H18), 31, 32, 33, 37 and 60Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days -30, 0 and 30, systolic pressure was assessed at multiple time points (plus 1.5, 3, 6, 9, 12 and 18 hours - H1.5, H3, H6, H9, H12 and H18).
Outcome measures
| Measure |
Engerix-B_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=30 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0 H6)
|
112 mmHg
Interval 103.0 to 117.0
|
117 mmHg
Interval 111.0 to 121.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0 H12)
|
114 mmHg
Interval 107.0 to 120.0
|
115 mmHg
Interval 110.0 to 126.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0 H18)
|
105 mmHg
Interval 99.0 to 122.0
|
112 mmHg
Interval 104.0 to 121.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30)
|
116 mmHg
Interval 106.0 to 125.0
|
123.5 mmHg
Interval 112.0 to 130.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H1.5)
|
114 mmHg
Interval 103.0 to 124.0
|
117 mmHg
Interval 111.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H3)
|
114 mmHg
Interval 105.0 to 118.0
|
117.5 mmHg
Interval 112.0 to 126.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H6)
|
112 mmHg
Interval 105.0 to 124.0
|
118 mmHg
Interval 113.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H9)
|
114.5 mmHg
Interval 106.0 to 123.0
|
120.5 mmHg
Interval 112.0 to 131.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H12)
|
112 mmHg
Interval 105.0 to 125.0
|
121.5 mmHg
Interval 112.0 to 129.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-30 H18)
|
106 mmHg
Interval 96.0 to 118.0
|
111 mmHg
Interval 106.0 to 122.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-29)
|
112 mmHg
Interval 104.0 to 122.0
|
116.5 mmHg
Interval 111.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-28)
|
114 mmHg
Interval 103.0 to 121.0
|
121 mmHg
Interval 110.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-27)
|
115.5 mmHg
Interval 109.0 to 121.0
|
119 mmHg
Interval 112.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, placebo (D-23)
|
115 mmHg
Interval 104.0 to 122.0
|
118 mmHg
Interval 110.0 to 123.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0)
|
114 mmHg
Interval 108.0 to 124.0
|
118 mmHg
Interval 112.0 to 122.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D0 H1.5)
|
109 mmHg
Interval 102.0 to 119.0
|
116 mmHg
Interval 110.5 to 121.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D1)
|
114 mmHg
Interval 104.0 to 123.0
|
114 mmHg
Interval 108.5 to 119.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D2)
|
111 mmHg
Interval 103.0 to 118.0
|
115 mmHg
Interval 110.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 1 (D7)
|
113 mmHg
Interval 107.0 to 123.0
|
116 mmHg
Interval 111.0 to 120.5
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30)
|
112.5 mmHg
Interval 106.5 to 122.5
|
115 mmHg
Interval 112.0 to 121.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H1.5)
|
109.5 mmHg
Interval 102.0 to 117.5
|
115 mmHg
Interval 108.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H3)
|
113 mmHg
Interval 103.0 to 120.5
|
116 mmHg
Interval 111.0 to 124.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H6)
|
112 mmHg
Interval 103.5 to 118.0
|
117 mmHg
Interval 107.0 to 122.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H9)
|
116 mmHg
Interval 108.5 to 124.0
|
117 mmHg
Interval 108.0 to 121.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H12)
|
116.5 mmHg
Interval 105.0 to 122.0
|
116 mmHg
Interval 109.0 to 125.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D30 H18)
|
107 mmHg
Interval 100.0 to 122.0
|
109.5 mmHg
Interval 102.0 to 115.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D31)
|
109.5 mmHg
Interval 104.0 to 119.0
|
114 mmHg
Interval 108.0 to 123.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D32)
|
110.5 mmHg
Interval 103.0 to 115.5
|
116 mmHg
Interval 113.0 to 120.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D33)
|
111.5 mmHg
Interval 106.0 to 119.5
|
116 mmHg
Interval 112.0 to 122.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D37)
|
112 mmHg
Interval 106.0 to 124.5
|
120 mmHg
Interval 108.0 to 126.0
|
|
Levels of Systolic Pressure - Step 1
Systolic, Dose 2 (D60)
|
115 mmHg
Interval 106.5 to 122.5
|
120 mmHg
Interval 109.0 to 125.0
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)Population: Analyses were performed on the According-To-Protocol (ATP) cohort for adaptive immunogenicity up to 30 days (step 2 only) post last vaccination, which included all evaluable subjects, who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point.
Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).
Outcome measures
| Measure |
Engerix-B_1 Group
n=8 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno
Anti-HBs, PRE
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno
Anti-HBs, D44
|
—
|
8447.1 mIU/mL
Interval 4040.7 to 17658.9
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Immuno
Anti-HBs, D194
|
1996.3 mIU/mL
Interval 143.8 to 27707.6
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE) and post-vaccination (Day 44 for HBsAg/AS_2 Group and Day 194 for Engerix-B_2 Group)Population: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 2 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180 for the HBsAg/AS\_2 Group and at Day 330 for the Engerix-B\_2 Group.
Anti-HBs antibody concentrations in serum were measured by CLIA Assay. Concentrations were presented as geometric mean concentrations, in milli-International Units per milliliter (mIU/mL).
Outcome measures
| Measure |
Engerix-B_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence
Anti-HBs, PRE
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
3.1 mIU/mL
Interval 3.1 to 3.1
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence
Anti-HBs, D44
|
—
|
8447.1 mIU/mL
Interval 4040.7 to 17658.9
|
|
Anti-Hepatitis B Surface (Anti-HBs) Antibody Concentrations in Serum - Step 2 Persistence
Anti-HBs, D194
|
2454.9 mIU/mL
Interval 311.4 to 19354.5
|
—
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Pain, Dose 1
|
3 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Redness, Dose 1
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Swelling, Dose 1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Pain, Dose 2
|
1 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Pain, Dose 2
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Redness, Dose 2
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Redness, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Swelling, Dose 2
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Pain, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Pain, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Redness, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Redness, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Swelling, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Swelling, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Pain, Across doses
|
4 Participants
|
10 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Pain, Across doses
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Redness, Across doses
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Redness, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Any Swelling, Across doses
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Step 2
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited local symptoms were pain, redness and swelling. Any = occurrence of the symptom regardless of intensity grade. Grade 3 pain = pain that prevented normal activity. Grade 3 redness/swelling = redness/swelling spreading beyond 100 millimeters (mm) of injection site.
Outcome measures
| Measure |
Engerix-B_1 Group
n=39 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Pain, Dose 1
|
10 Participants
|
28 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Pain, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Redness, Dose 1
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Redness, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Swelling, Dose 1
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Swelling, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Pain, Dose 2
|
7 Participants
|
25 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Pain, Dose 2
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Redness, Dose 2
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Redness, Dose 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Swelling, Dose 2
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Swelling, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Pain, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Pain, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Redness, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Redness, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Swelling, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Swelling, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Pain, Across doses
|
12 Participants
|
31 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Pain, Across doses
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Redness, Across doses
|
1 Participants
|
12 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Redness, Across doses
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Any Swelling, Across doses
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Any and Grade 3 Solicited Local Symptoms - Pooling Step
Grade 3 Swelling, Across doses
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise, myalgia, shivering and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. At Day 0 of dose 2, two temperatures were collected: one at Hour 0 (H0) and a second one at Hour 18 (H18). The highest temperature between H0 et H18 was taken.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Fatigue, Dose 1
|
3 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Fatigue, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Fatigue, Dose 1
|
2 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Gastrointestinal Symptoms, Dose 1
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Gastrointestinal Symptoms, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Gastrointestinal Symptoms, Dose 1
|
3 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Headache, Dose 1
|
4 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Headache, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Headache, Dose 1
|
3 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Malaise, Dose 1
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Malaise, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Malaise, Dose 1
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Myalgia, Dose 1
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Myalgia, Dose 1
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Shivering, Dose 1
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Shivering, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Shivering, Dose 1
|
1 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Temperature, Dose 1
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Temperature, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Temperature, Dose 1
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Fatigue, Dose 2
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Fatigue, Dose 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Fatigue, Dose 2
|
1 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Gastrointestinal Symptoms, Dose 2
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Gastrointestinal Symptoms, Dose 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Gastrointestinal Symptoms, Dose 2
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Headache, Dose 2
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Headache, Dose 2
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Headache, Dose 2
|
0 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Malaise, Dose 2
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Malaise, Dose 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Malaise, Dose 2
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Myalgia, Dose 2
|
0 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Myalgia, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Myalgia, Dose 2
|
0 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Shivering, Dose 2
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Shivering, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Shivering, Dose 2
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Temperature, Dose 2
|
2 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Temperature, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Temperature, Dose 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Fatigue, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Fatigue, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Fatigue, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Gastrointestinal Symptoms, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Gastrointestinal Symptoms, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Gastrointestinal Symptoms, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Headache, Dose 3
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Headache, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Headache, Dose 3
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Malaise, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Malaise, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Malaise, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Myalgia, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Myalgia, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Myalgia, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Shivering, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Shivering, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Shivering, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Temperature, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Temperature, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Temperature, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Fatigue, Across doses
|
3 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Fatigue, Across doses
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Fatigue, Across doses
|
2 Participants
|
8 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Gastrointestinal Symptoms, Across doses
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Gastrointestinal Symptoms, Across doses
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Gastrointestinal Symptoms, Across doses
|
4 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Headache, Across doses
|
5 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Headache, Across doses
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Headache, Across doses
|
4 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Malaise, Across doses
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Malaise, Across doses
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Malaise, Across doses
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Myalgia, Across doses
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Myalgia, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Myalgia, Across doses
|
1 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Shivering, Across doses
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Shivering, Across doses
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Shivering, Across doses
|
1 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Any Temperature, Across doses
|
3 Participants
|
6 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Grade 3 Temperature, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Step 2
Related Temperature, Across doses
|
0 Participants
|
3 Participants
|
SECONDARY outcome
Timeframe: During the 7-day (Days 0-6) post-vaccination period following each vaccine dose and across dosesPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited general symptoms were fatigue, gastrointestinal symptoms \[nausea, vomiting, diarrhoea and/or abdominal pain\], headache, malaise, myalgia, shivering and temperature \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\]. Any = occurrence of the symptom regardless of intensity grade. Grade 3 symptom = symptom that prevented normal activity. Grade 3 fever = fever \> 39.5 °C. Related = symptom assessed by the investigator as related to the vaccination. There was no pooling for temperature symptom between Step 1 and Step 2 due to difference in recording approach for the 18 hour data (nurse or self-assessment).
Outcome measures
| Measure |
Engerix-B_1 Group
n=39 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Headache, Dose 2
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Gastrointestinal Symptoms, Dose 2
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Headache, Dose 2
|
5 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Headache, Dose 2
|
5 Participants
|
20 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Malaise, Dose 2
|
6 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Malaise, Dose 2
|
1 Participants
|
3 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Malaise, Dose 2
|
6 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Myalgia, Dose 2
|
3 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Myalgia, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Myalgia, Dose 2
|
1 Participants
|
19 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Shivering, Dose 2
|
2 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Shivering, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Shivering, Dose 2
|
2 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Fatigue, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Fatigue, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Fatigue, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Gastrointestinal Symptoms, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Gastrointestinal Symptoms, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Gastrointestinal Symptoms, Dose 3
|
1 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Headache, Dose 3
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Headache, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Headache, Dose 3
|
2 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Malaise, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Malaise, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Malaise, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Myalgia, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Myalgia, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Myalgia, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Shivering, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Shivering, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Shivering, Dose 3
|
0 Participants
|
—
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Fatigue, Across doses
|
12 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Fatigue, Across doses
|
0 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Fatigue, Across doses
|
11 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Gastrointestinal Symptoms, Across doses
|
12 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Gastrointestinal Symptoms, Across doses
|
4 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Gastrointestinal Symptoms, Across doses
|
11 Participants
|
14 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Headache, Across doses
|
11 Participants
|
26 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Headache, Across doses
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Headache, Across doses
|
10 Participants
|
24 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Malaise, Across doses
|
7 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Malaise, Across doses
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Malaise, Across doses
|
7 Participants
|
15 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Myalgia, Across doses
|
4 Participants
|
23 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Myalgia, Across doses
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Myalgia, Across doses
|
3 Participants
|
22 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Shivering, Across doses
|
3 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Shivering, Across doses
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Shivering, Across doses
|
3 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Fatigue, Dose 1
|
9 Participants
|
11 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Fatigue, Dose 1
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Fatigue, Dose 1
|
8 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Gastrointestinal Symptoms, Dose 1
|
9 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Gastrointestinal Symptoms, Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Gastrointestinal Symptoms, Dose 1
|
6 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Headache, Dose 1
|
9 Participants
|
21 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Headache, Dose 1
|
1 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Headache, Dose 1
|
7 Participants
|
18 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Malaise, Dose 1
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Malaise, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Malaise, Dose 1
|
2 Participants
|
9 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Myalgia, Dose 1
|
2 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Myalgia, Dose 1
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Myalgia, Dose 1
|
2 Participants
|
16 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Shivering, Dose 1
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Shivering, Dose 1
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Shivering, Dose 1
|
1 Participants
|
4 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Fatigue, Dose 2
|
9 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Fatigue, Dose 2
|
0 Participants
|
2 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Related Fatigue, Dose 2
|
8 Participants
|
17 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Any Gastrointestinal Symptoms, Dose 2
|
5 Participants
|
7 Participants
|
|
Number of Subjects With Any, Grade 3 and Related Solicited General Symptoms - Pooling Step
Grade 3 Gastrointestinal Symptoms, Dose 2
|
3 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Within the 28-day (Days 0-27) and post-vaccination periodPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Step 2
|
4 Participants
|
5 Participants
|
SECONDARY outcome
Timeframe: Within the 28-day (Days 0-27) post-vaccination period.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset out-side the specified period of follow-up for solicited symptoms. Any was defined as the occurrence of any unsolicited AE regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Engerix-B_1 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Unsolicited Adverse Events (AEs) - Pooling Step
|
19 Participants
|
20 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Step 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Serious adverse events (SAEs) assessed include medical occurrences that result in death, are life threatening, require hospitalization or prolongation of hospitalization or result in disability/incapacity.
Outcome measures
| Measure |
Engerix-B_1 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Serious Adverse Events (SAEs) - Pooling Step
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented
PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Step 2
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
PIMD(s) are a subset of AEs that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Outcome measures
| Measure |
Engerix-B_1 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any Potential Immune-mediated Disorders (pIMDs) - Pooling Step
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_2 Group and up to Day 330 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Step 2
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
MAEs were defined as events for which the subject received medical attention defined as hospitalization, an emergency room visit, or a visit to or from medical personnel (medical doctor) for any reason. Any MAE(s) = Occurrence of any MAE(s) regardless of intensity grade or relation to vaccination.
Outcome measures
| Measure |
Engerix-B_1 Group
n=40 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=38 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Any New Medical Conditions Requiring Medical Attention (MAEs) - Pooling Step
|
1 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included ALT levels. ALT concentrations were expressed in units per liter (U/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, PRE
|
31 U/L
Interval 28.0 to 38.0
|
27.5 U/L
Interval 23.0 to 33.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D30
|
—
|
25.5 U/L
Interval 25.0 to 31.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D32
|
—
|
27 U/L
Interval 20.0 to 36.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D37
|
—
|
23 U/L
Interval 18.0 to 31.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D60
|
—
|
30 U/L
Interval 23.0 to 33.0
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D180
|
34.5 U/L
Interval 27.0 to 45.0
|
—
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D182
|
31 U/L
Interval 25.0 to 42.0
|
—
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D187
|
34 U/L
Interval 29.0 to 40.0
|
—
|
|
Levels of Alanine Aminotransferase (ALT) in Blood Samples - Step 2
ALT, D210
|
29.5 U/L
Interval 22.0 to 48.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included AST levels. AST concentrations were expressed in units per liter (U/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, PRE
|
28 U/L
Interval 23.0 to 38.0
|
22.5 U/L
Interval 21.0 to 24.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D30
|
—
|
22.5 U/L
Interval 20.0 to 26.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D32
|
—
|
24 U/L
Interval 22.0 to 26.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D37
|
—
|
20.5 U/L
Interval 18.0 to 24.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D60
|
—
|
21.5 U/L
Interval 18.0 to 31.0
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D180
|
25 U/L
Interval 18.0 to 43.0
|
—
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D182
|
29 U/L
Interval 23.0 to 39.0
|
—
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D187
|
25 U/L
Interval 20.0 to 36.0
|
—
|
|
Levels of Aspartate Aminotransferase (AST) in Blood Samples - Step 2
AST, D210
|
22.5 U/L
Interval 20.0 to 28.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included basophil levels. Basophil levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, PRE
|
0.03 billion cells/L
Interval 0.02 to 0.04
|
0.04 billion cells/L
Interval 0.02 to 0.05
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D30
|
—
|
0.02 billion cells/L
Interval 0.01 to 0.07
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D32
|
—
|
0.04 billion cells/L
Interval 0.02 to 0.05
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D37
|
—
|
0.03 billion cells/L
Interval 0.01 to 0.06
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D60
|
—
|
0.05 billion cells/L
Interval 0.02 to 0.06
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D180
|
0.02 billion cells/L
Interval 0.01 to 0.04
|
—
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D182
|
0.02 billion cells/L
Interval 0.01 to 0.04
|
—
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D187
|
0.03 billion cells/L
Interval 0.02 to 0.05
|
—
|
|
Levels of Basophils in Blood Samples - Step 2
Basophils, D210
|
0.03 billion cells/L
Interval 0.01 to 0.04
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included CRP levels. CRP concentrations were expressed in milligrams per liter (mg/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, PRE
|
5.8 mg/L
Interval 5.0 to 9.5
|
5.55 mg/L
Interval 5.0 to 6.8
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D2
|
5 mg/L
Interval 5.0 to 8.8
|
24.2 mg/L
Interval 16.6 to 32.7
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D30
|
—
|
6.8 mg/L
Interval 5.1 to 8.2
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D31
|
—
|
20.45 mg/L
Interval 10.4 to 21.9
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D32
|
—
|
33.75 mg/L
Interval 12.7 to 44.6
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D37
|
—
|
6.7 mg/L
Interval 5.5 to 10.0
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D60
|
—
|
5 mg/L
Interval 5.0 to 6.2
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D180
|
5.25 mg/L
Interval 5.0 to 6.8
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D181
|
5 mg/L
Interval 5.0 to 6.0
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D182
|
5 mg/L
Interval 5.0 to 7.3
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D187
|
5 mg/L
Interval 5.0 to 6.7
|
—
|
|
Levels of Serum C Reactive Protein (CRP) in Blood Samples - Step 2
CRP, D210
|
5 mg/L
Interval 5.0 to 7.8
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included eosinophil levels. Eosinophil levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, PRE
|
0.18 billion cells/L
Interval 0.1 to 0.29
|
0.16 billion cells/L
Interval 0.09 to 0.23
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D30
|
—
|
0.17 billion cells/L
Interval 0.12 to 0.23
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D32
|
—
|
0.25 billion cells/L
Interval 0.17 to 0.33
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D37
|
—
|
0.19 billion cells/L
Interval 0.11 to 0.26
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D60
|
—
|
0.2 billion cells/L
Interval 0.09 to 0.26
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D180
|
0.14 billion cells/L
Interval 0.1 to 0.2
|
—
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D182
|
0.17 billion cells/L
Interval 0.11 to 0.19
|
—
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D187
|
0.18 billion cells/L
Interval 0.16 to 0.27
|
—
|
|
Levels of Eosinophils in Blood Samples - Step 2
Eosinophils, D210
|
0.16 billion cells/L
Interval 0.09 to 0.26
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included white blood cells levels. WBC levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, PRE
|
5.67 billion cells/L
Interval 5.13 to 7.46
|
6.93 billion cells/L
Interval 5.51 to 9.67
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D30
|
—
|
6.41 billion cells/L
Interval 5.7 to 6.6
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D32
|
—
|
6.29 billion cells/L
Interval 5.24 to 8.09
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D37
|
—
|
6.37 billion cells/L
Interval 5.42 to 7.06
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D60
|
—
|
7.03 billion cells/L
Interval 5.65 to 8.5
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D180
|
6.02 billion cells/L
Interval 5.25 to 8.3
|
—
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D182
|
6.15 billion cells/L
Interval 5.6 to 8.1
|
—
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D187
|
7.35 billion cells/L
Interval 5.46 to 7.61
|
—
|
|
Levels of White Blood Cell (WBC) in Blood Samples - Step 2
WBC, D210
|
5.91 billion cells/L
Interval 4.48 to 8.53
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included lymphocyte levels. Lymphocyte levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D0
|
1.96 billion cells/L
Interval 1.69 to 2.37
|
2.13 billion cells/L
Interval 1.83 to 2.55
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D30
|
—
|
2.14 billion cells/L
Interval 1.8 to 2.47
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D32
|
—
|
1.7 billion cells/L
Interval 1.47 to 1.82
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D37
|
—
|
2.12 billion cells/L
Interval 1.98 to 2.32
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D60
|
—
|
2.12 billion cells/L
Interval 1.72 to 2.34
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D180
|
1.93 billion cells/L
Interval 1.84 to 2.45
|
—
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D182
|
2.04 billion cells/L
Interval 1.75 to 2.44
|
—
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D187
|
2.07 billion cells/L
Interval 1.76 to 2.27
|
—
|
|
Levels of Lymphocytes in Blood Samples - Step 2
Lymphocytes, D210
|
1.91 billion cells/L
Interval 1.46 to 2.94
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included monocyte levels. Monocyte levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D0
|
0.5 billion cells/L
Interval 0.28 to 0.69
|
0.64 billion cells/L
Interval 0.47 to 0.74
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D30
|
—
|
0.54 billion cells/L
Interval 0.38 to 0.62
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D32
|
—
|
0.87 billion cells/L
Interval 0.8 to 1.07
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D37
|
—
|
0.47 billion cells/L
Interval 0.43 to 0.58
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D60
|
—
|
0.58 billion cells/L
Interval 0.49 to 0.68
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D180
|
0.46 billion cells/L
Interval 0.39 to 0.57
|
—
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D182
|
0.43 billion cells/L
Interval 0.42 to 0.66
|
—
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D187
|
0.44 billion cells/L
Interval 0.37 to 0.55
|
—
|
|
Levels of Monocytes in Blood Samples - Step 2
Monocytes, D210
|
0.52 billion cells/L
Interval 0.34 to 0.62
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included neutrophil levels. Neutrophil levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D0
|
3.11 billion cells/L
Interval 2.3 to 4.56
|
4.02 billion cells/L
Interval 3.12 to 6.22
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D30
|
—
|
3.41 billion cells/L
Interval 2.87 to 3.93
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D32
|
—
|
3.42 billion cells/L
Interval 2.78 to 5.01
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D37
|
—
|
3.22 billion cells/L
Interval 2.76 to 3.9
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D60
|
—
|
4.18 billion cells/L
Interval 2.96 to 5.34
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D180
|
3.29 billion cells/L
Interval 2.99 to 4.67
|
—
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D182
|
3.16 billion cells/L
Interval 2.89 to 4.88
|
—
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D187
|
3.9 billion cells/L
Interval 3.18 to 4.29
|
—
|
|
Levels of Neutrophils in Blood Samples - Step 2
Neutrophils, D210
|
3.28 billion cells/L
Interval 2.29 to 4.88
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Haematological laboratory parameters assessed included platelet count levels. Platelet count levels were expressed in billion cells per liter (billion cells/L).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Platelet Count in Blood Samples - Step 2
Platelets, D32
|
—
|
257 billion cells/L
Interval 204.0 to 303.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D0
|
272 billion cells/L
Interval 215.0 to 322.0
|
269 billion cells/L
Interval 255.0 to 312.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D30
|
—
|
272.5 billion cells/L
Interval 215.0 to 330.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D37
|
—
|
315.5 billion cells/L
Interval 286.0 to 330.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D60
|
—
|
282 billion cells/L
Interval 257.0 to 323.0
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D180
|
247 billion cells/L
Interval 237.0 to 276.0
|
—
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D182
|
263 billion cells/L
Interval 248.0 to 274.0
|
—
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D187
|
272 billion cells/L
Interval 260.0 to 280.0
|
—
|
|
Platelet Count in Blood Samples - Step 2
Platelets, D210
|
264.5 billion cells/L
Interval 214.0 to 314.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30, Day 32, Day 37, Day 60 for the HBsAg/AS_2 Group and Day 0 (PRE) Day 180, Day 182, Day 187 and Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Biochemical laboratory parameters assessed included total bilirubin levels. Bilirubin concentrations were expressed in milligrams per deciliter (mG/dL).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D187
|
0.5 mg/dL
Interval 0.5 to 0.7
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, PRE
|
0.5 mg/dL
Interval 0.3 to 0.7
|
0.4 mg/dL
Interval 0.4 to 0.8
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D2
|
0.5 mg/dL
Interval 0.3 to 1.5
|
0.45 mg/dL
Interval 0.4 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D30
|
—
|
0.45 mg/dL
Interval 0.3 to 0.8
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D31
|
—
|
0.55 mg/dL
Interval 0.4 to 1.0
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D32
|
—
|
0.4 mg/dL
Interval 0.2 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D37
|
—
|
0.45 mg/dL
Interval 0.3 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D60
|
—
|
0.4 mg/dL
Interval 0.3 to 0.6
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D180
|
0.45 mg/dL
Interval 0.4 to 0.6
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D181
|
0.6 mg/dL
Interval 0.4 to 0.7
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D182
|
0.6 mg/dL
Interval 0.5 to 0.7
|
—
|
|
Levels of Total Bilirubin in Blood Samples - Step 2
Total Bilirubin, D210
|
0.6 mg/dL
Interval 0.5 to 0.7
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Diastolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, diastolic blood pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D0
|
70 mmHg
Interval 67.0 to 72.0
|
74 mmHg
Interval 69.0 to 75.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D30 H0
|
—
|
74.5 mmHg
Interval 73.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D30 H6
|
—
|
71 mmHg
Interval 69.0 to 75.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D31
|
—
|
71.5 mmHg
Interval 68.0 to 78.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D32
|
—
|
71.5 mmHg
Interval 66.0 to 82.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D37
|
—
|
70 mmHg
Interval 69.0 to 76.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D60
|
—
|
72 mmHg
Interval 68.0 to 77.0
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D180 H0
|
69 mmHg
Interval 63.0 to 71.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D180 H6
|
68.5 mmHg
Interval 65.0 to 71.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D181
|
72 mmHg
Interval 66.0 to 75.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D182
|
70 mmHg
Interval 69.0 to 72.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D187
|
72 mmHg
Interval 64.0 to 77.0
|
—
|
|
Levels of Diastolic Blood Pressure - Step 2
Diastolic, D210
|
71.5 mmHg
Interval 65.0 to 74.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Heart rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed in beats per minute. On Days 30 and 180, heart rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Heart Rate - Step 2
Heart rate, PRE
|
70 beats/minute
Interval 62.0 to 80.0
|
72 beats/minute
Interval 63.0 to 80.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D30 H0
|
—
|
70 beats/minute
Interval 65.0 to 81.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D30 H6
|
—
|
68 beats/minute
Interval 64.0 to 77.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D31
|
—
|
84 beats/minute
Interval 70.0 to 90.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D32
|
—
|
73 beats/minute
Interval 67.0 to 83.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D37
|
—
|
65 beats/minute
Interval 56.0 to 73.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D60
|
—
|
65 beats/minute
Interval 62.0 to 72.0
|
|
Levels of Heart Rate - Step 2
Heart rate, D180 H0
|
71.5 beats/minute
Interval 63.0 to 86.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D180 H6
|
70 beats/minute
Interval 58.0 to 80.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D181
|
81 beats/minute
Interval 73.0 to 91.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D182
|
72 beats/minute
Interval 71.0 to 83.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D187
|
78 beats/minute
Interval 67.0 to 84.0
|
—
|
|
Levels of Heart Rate - Step 2
Heart rate, D210
|
76.5 beats/minute
Interval 68.0 to 79.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Respiratory Rate was part of the list of vital signs followed at specific protocol-defined time points during this study. It was expressed as breaths per minute (breaths/min). On Days 30 and 180, respiratory rate was assessed at multiple time points (plus 0 and 6 hours - H0, H6).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, PRE
|
12 breaths/min
Interval 12.0 to 14.0
|
12 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D30 H0
|
—
|
12.5 breaths/min
Interval 11.0 to 13.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D30 H6
|
—
|
12 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D31
|
—
|
13 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D32
|
—
|
12 breaths/min
Interval 12.0 to 13.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D37
|
—
|
13.5 breaths/min
Interval 12.0 to 14.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D60
|
—
|
12 breaths/min
Interval 12.0 to 13.0
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D180 H0
|
12.5 breaths/min
Interval 12.0 to 15.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D180 H6
|
12.5 breaths/min
Interval 12.0 to 14.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D181
|
12 breaths/min
Interval 12.0 to 14.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D182
|
13 breaths/min
Interval 12.0 to 14.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D187
|
13 breaths/min
Interval 12.0 to 15.0
|
—
|
|
Levels of Respiratory Rate - Step 2
Respiratory rate, D210
|
13.5 breaths/min
Interval 12.0 to 15.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 (PRE), Day 30 (H0, H6) at Day 31, at Day 32, at Day 37, at Day 60 for the HBsAg/AS_2 Group and at Day 0 (PRE), Day 180 (H0, H6), Day 181, at Day 182, at Day 187 and at Day 210 for the Engerix-B_2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Systolic pressure was part of the list of vital signs followed at specific protocol-defined time points during this study, measured in millimeter of mercury (mmHg). On Days 30 and 180, systolic pressure was assessed at multiple time points (plus 0 and 6 hours - H0, H6).
Outcome measures
| Measure |
Engerix-B_1 Group
n=11 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Levels of Systolic Pressure - Step 2
Systolic, D180 H0
|
111.5 mmHg
Interval 105.0 to 119.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, PRE
|
112 mmHg
Interval 103.0 to 115.0
|
114 mmHg
Interval 110.0 to 116.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D30 H0
|
—
|
114 mmHg
Interval 109.0 to 118.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D30 H6
|
—
|
116 mmHg
Interval 104.0 to 121.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D31
|
—
|
112 mmHg
Interval 108.0 to 113.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D32
|
—
|
111.5 mmHg
Interval 102.0 to 116.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D37
|
—
|
108.5 mmHg
Interval 105.0 to 117.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D60
|
—
|
113 mmHg
Interval 104.0 to 122.0
|
|
Levels of Systolic Pressure - Step 2
Systolic, D180 H6
|
111.5 mmHg
Interval 108.0 to 114.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D181
|
115 mmHg
Interval 112.0 to 129.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D182
|
117 mmHg
Interval 108.0 to 120.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D187
|
112 mmHg
Interval 110.0 to 115.0
|
—
|
|
Levels of Systolic Pressure - Step 2
Systolic, D210
|
112 mmHg
Interval 108.0 to 116.0
|
—
|
SECONDARY outcome
Timeframe: At Day 0 prior to vaccination (PRE) and Day 44 post-vaccinationPopulation: The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).
Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
-Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
PRE
|
1 T cells/million cells
Interval 1.0 to 18.0
|
8 T cells/million cells
Interval 1.0 to 52.0
|
|
-Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 44
|
268 T cells/million cells
Interval 76.0 to 509.0
|
4494 T cells/million cells
Interval 2441.0 to 7494.0
|
SECONDARY outcome
Timeframe: At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180.
Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
Engerix-B_1 Group
n=24 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
PRE
|
1 T cells/ million cells
Interval 1.0 to 21.0
|
8 T cells/ million cells
Interval 1.0 to 52.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 44
|
260 T cells/ million cells
Interval 33.0 to 527.0
|
4494 T cells/ million cells
Interval 2441.0 to 7494.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)4+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 180
|
34 T cells/ million cells
Interval 1.0 to 155.0
|
1119 T cells/ million cells
Interval 748.0 to 2181.0
|
SECONDARY outcome
Timeframe: At Day 0 prior to vaccination (PRE) and Day 44 post-vaccinationPopulation: The analysis was performed on the ATP cohort for adaptive immunogenicity up to Day 60 (step 1 only) which included all evaluable subjects who complied with the protocol and for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at one post-vaccination time point (up to Day 60).
Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluste of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
Engerix-B_1 Group
n=25 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=26 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
PRE
|
1 T cells/ million cells
Interval 1.0 to 1.0
|
1 T cells/ million cells
Interval 1.0 to 24.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 44
|
1 T cells/ million cells
Interval 1.0 to 33.0
|
38 T cells/ million cells
Interval 1.0 to 108.0
|
SECONDARY outcome
Timeframe: At Day 0 prior to vaccination (PRE), Day 44 and Day 180 post-vaccinationPopulation: The analysis was performed on the According-To-Protocol (ATP) cohort for persistence (step 1 only) included all evaluable subjects, who complied with the protocol, for whom data concerning adaptive immunogenicity were available for at least one adaptive assay at Day 180.
Markers expressed were Interleukin-2 (IL-2), Interferon gamma (IFN-γ), Tumor Necrosis Factor (TNF)-α and Cluster of differentiation 40-Ligand (CD40L), as measured by classical (qualified assay) Intracellular Cytokine Staining (ICS),using frozen Peripheral blood mononuclear cells (PBMCs).
Outcome measures
| Measure |
Engerix-B_1 Group
n=24 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=27 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
PRE
|
1 T ceclls/ million cells
Interval 1.0 to 1.0
|
1 T ceclls/ million cells
Interval 1.0 to 24.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 44
|
1 T ceclls/ million cells
Interval 1.0 to 42.0
|
38 T ceclls/ million cells
Interval 1.0 to 108.0
|
|
Frequency of Hepatitis B Virus (HBs)-Specific Cluster of Differentiation (CD)8+ T-cells Expressing at Least 2 Immune Markers - Step 1
Day 180
|
1 T ceclls/ million cells
Interval 1.0 to 31.0
|
1 T ceclls/ million cells
Interval 1.0 to 17.0
|
SECONDARY outcome
Timeframe: Up to 3 days post-placebo/vaccine administration.Population: The analysis was performed on the Total Vaccinated cohort, which included all subjects with the vaccine administration documented.
Assessed solicited symptoms were fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], pain, redness \[spreading beyond 20 millimeters (mm) of injection site\], induration \[spreading beyond 20 millimeters (mm) of injection site\], swelling \[spreading beyond 20 millimeters (mm) of injection site\] and muscle stiffness.
Outcome measures
| Measure |
Engerix-B_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=10 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Pain, Dose 2
|
0 Participants
|
8 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Pain, Dose 3
|
1 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Redness, Dose 2
|
0 Participants
|
5 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Redness, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Swelling, Dose 2
|
0 Participants
|
3 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Swelling, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Induration, Dose 2
|
0 Participants
|
1 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Induration, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Fever, Dose 2
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Fever, Dose 3
|
0 Participants
|
0 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Muscle stiffness, Dose 2
|
0 Participants
|
7 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Step 2
Muscle stiffness, Dose 3
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to 3 days post-Dose 2 vaccine administration in HBsAg/AS_1+2 GroupPopulation: The analysis was performed on the Total Vaccinated cohort, of the HBsAg/AS\_1+2 Group only, which included all subjects with the vaccine administration documented.
Assessed solicited symptoms were fever \[defined as oral temperature equal to or above (≥) 37.5 degrees Celsius (°C)\], pain, redness \[spreading beyond 20 millimeters (mm) of injection site\], induration \[spreading beyond 20 millimeters (mm) of injection site\], swelling \[spreading beyond 20 millimeters (mm) of injection site\] and muscle stiffness.
Outcome measures
| Measure |
Engerix-B_1 Group
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
HBsAg/AS_1 Group
n=37 Participants
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Pain
|
—
|
26 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Redness
|
—
|
12 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Swelling
|
—
|
7 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Induration
|
—
|
2 Participants
|
|
Number of Subjects With Solicited Symptoms, as Assessed by the Investigator/Study Nurse - Pooling Step
Muscle stiffness
|
—
|
22 Participants
|
Adverse Events
HBsAg/AS_1+2 Group
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Engerix-B_1+2 Group
Serious events: 1 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
HBsAg/AS_1+2 Group
n=38 participants at risk
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
n=40 participants at risk
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
2.5%
1/40 • Number of events 1 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
Other adverse events
| Measure |
HBsAg/AS_1+2 Group
n=38 participants at risk
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30, followed by 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30; and during Step 2 of the study, 2 doses of HBsAg/AS vaccine, at Day 0 and Day 30. All vaccines were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
Engerix-B_1+2 Group
n=40 participants at risk
Subjects received, during Step 1 of the study, 1 dose of Placebo vaccine at Day -30 followed by 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180; and during Step 2 of the study, 3 doses of Engerix™-B vaccine at Day 0, Day 30 and Day 180. All vaccine were administered intramuscularly into the deltoid muscle of the non-dominant upper arm.
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
3/38 • Number of events 3 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
0.00%
0/40 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
7.5%
3/40 • Number of events 3 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
General disorders
Fatigue
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
5.0%
2/40 • Number of events 2 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Nervous system disorders
Headache
|
5.3%
2/38 • Number of events 3 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
12.5%
5/40 • Number of events 5 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
General disorders
Influenza like illness
|
5.3%
2/38 • Number of events 2 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
0.00%
0/40 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Nervous system disorders
Migraine
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
5.0%
2/40 • Number of events 5 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Infections and infestations
Nasopharyngitis
|
13.2%
5/38 • Number of events 5 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
2.5%
1/40 • Number of events 1 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Infections and infestations
Oral herpes
|
5.3%
2/38 • Number of events 2 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
2.5%
1/40 • Number of events 1 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
15.8%
6/38 • Number of events 7 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
2.5%
1/40 • Number of events 1 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/38 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
5.0%
2/40 • Number of events 2 • Solicited and unsolicited symptoms: during the 28 Day (Days 0-27) post-vaccination period; SAEs: up to Day 180 for the HBsAg/AS_1+2 Group and up to Day 330 for the Engerix-B_1+2 Group.
The safety analysis did not include subjects who received only the Placebo dose.
|
Additional Information
GSK Response Center
GlaxoSmithKline
Phone: 866-435-7343
Results disclosure agreements
- Principal investigator is a sponsor employee GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
- Publication restrictions are in place
Restriction type: OTHER