Trial Outcomes & Findings for Immunogenicity of Hepatitis B Vaccination Among Drug Users (NCT NCT02959775)
NCT ID: NCT02959775
Last Updated: 2022-02-18
Results Overview
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
COMPLETED
PHASE4
480 participants
Month 7
2022-02-18
Participant Flow
Participant milestones
| Measure |
IM20 Group
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
Participants received no intervention.
|
|---|---|---|---|
|
Overall Study
STARTED
|
160
|
160
|
160
|
|
Overall Study
COMPLETED
|
133
|
133
|
124
|
|
Overall Study
NOT COMPLETED
|
27
|
27
|
36
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immunogenicity of Hepatitis B Vaccination Among Drug Users
Baseline characteristics by cohort
| Measure |
IM20 Group
n=160 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=160 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=160 Participants
Participants received no intervention.
|
Total
n=480 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
37.0 years
STANDARD_DEVIATION 8.7 • n=39 Participants
|
36.4 years
STANDARD_DEVIATION 8.6 • n=41 Participants
|
36.7 years
STANDARD_DEVIATION 8.3 • n=35 Participants
|
36.7 years
STANDARD_DEVIATION 8.5 • n=31 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=39 Participants
|
0 Participants
n=41 Participants
|
0 Participants
n=35 Participants
|
0 Participants
n=31 Participants
|
|
Sex: Female, Male
Male
|
160 Participants
n=39 Participants
|
160 Participants
n=41 Participants
|
160 Participants
n=35 Participants
|
480 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
Han ethnicity
|
158 Participants
n=39 Participants
|
158 Participants
n=41 Participants
|
158 Participants
n=35 Participants
|
474 Participants
n=31 Participants
|
|
Race/Ethnicity, Customized
minority ethnicity
|
2 Participants
n=39 Participants
|
2 Participants
n=41 Participants
|
2 Participants
n=35 Participants
|
6 Participants
n=31 Participants
|
|
Region of Enrollment
China · Urban
|
67 Participants
n=39 Participants
|
62 Participants
n=41 Participants
|
69 Participants
n=35 Participants
|
198 Participants
n=31 Participants
|
|
Region of Enrollment
China · Rural
|
93 Participants
n=39 Participants
|
98 Participants
n=41 Participants
|
91 Participants
n=35 Participants
|
282 Participants
n=31 Participants
|
PRIMARY outcome
Timeframe: Month 7Population: Exclusion of participants who did not received/competed vaccine or left the centers.150, 149 and 151 patients in the IM20, IM60 and blank control groups completed the followed-up at months 7 .
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Outcome measures
| Measure |
IM20 Group
n=150 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=149 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=151 Participants
Participants received no intervention
|
|---|---|---|---|
|
Number and Rate of Participants With Anti-HBs Seroconversion at Month 7
|
142 Participants
|
138 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Month 7The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Outcome measures
| Measure |
IM20 Group
n=150 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=149 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=151 Participants
Participants received no intervention
|
|---|---|---|---|
|
Anti-HBs Concentration at Month 7
|
909.6 mIU/mL
Interval 671.8 to 1147.5
|
2022.5 mIU/mL
Interval 1379.8 to 2665.1
|
0.3 mIU/mL
Interval 0.2 to 0.5
|
SECONDARY outcome
Timeframe: Month 12Population: 133, 133 and 124 patients in the IM20, IM60 and blank control groups completed the followed-up at months 12 .
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）.
Outcome measures
| Measure |
IM20 Group
n=133 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=133 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=124 Participants
Participants received no intervention
|
|---|---|---|---|
|
Anti-HBs Concentration at Month 12
|
470.5 mIU/mL
Interval 268.3 to 672.8
|
676.7 mIU/mL
Interval 458.8 to 894.6
|
0.3 mIU/mL
Interval 0.2 to 0.6
|
SECONDARY outcome
Timeframe: Month 12Population: 133, 133 and 124 patients in the IM20, IM60 and blank control groups completed the followed-up at months 12.
The measurements of anti-HBs antibodies were determined quantitatively by CMIA（Chemiluminescent Microparticle Immunoassay）. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Outcome measures
| Measure |
IM20 Group
n=133 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=133 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=124 Participants
Participants received no intervention
|
|---|---|---|---|
|
Number and Rate of Participants With Anti-HBs Seroconversion at Month 12
|
119 Participants
|
122 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Within 7 days after the vaccination, at Month 0, 1, and 6Population: 158 participants in the IM20 group and 156 in the IM60 group received the first injection. The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
Occurrence of adverse reactions within 7 days after vaccination with the hepatitis B
Outcome measures
| Measure |
IM20 Group
n=158 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=156 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
Participants received no intervention
|
|---|---|---|---|
|
Occurrence of Adverse Events After Vaccination
|
14 Participants
|
13 Participants
|
—
|
SECONDARY outcome
Timeframe: Within 28 days after the vaccination, at Month 0, 1, and 6Population: The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
Occurrence of adverse reactions within 28 days after vaccination with the hepatitis B
Outcome measures
| Measure |
IM20 Group
n=158 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=156 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
Participants received no intervention
|
|---|---|---|---|
|
Occurrence of Adverse Events After Vaccination
|
2 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Month 0-12Population: The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
Outcome measures
| Measure |
IM20 Group
n=133 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=133 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
Participants received no intervention
|
|---|---|---|---|
|
Serious Adverse Events (SAE) Occurred During Month 12
|
0 Participants
|
0 Participants
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 7The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Outcome measures
| Measure |
IM20 Group
n=150 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=149 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=151 Participants
Participants received no intervention
|
|---|---|---|---|
|
Number and Rate of Participants With Anti-HBs High-level Response at Month 7
|
111 Participants
|
116 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 12The measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Outcome measures
| Measure |
IM20 Group
n=133 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=133 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=124 Participants
Participants received no intervention
|
|---|---|---|---|
|
Number and Rate of Participants With Anti-HBs High-level Response at Month 12
|
73 Participants
|
91 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 before the third injectionPopulation: 155 and 150 patients in the IM20 and IM60 groups completed the followed-up at months 6 before the third injection.
Anti-HBs concentration at month 6 before the third injection by CMIA
Outcome measures
| Measure |
IM20 Group
n=155 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=150 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=151 Participants
Participants received no intervention
|
|---|---|---|---|
|
Anti-HBs Concentration at Month 6 Before the Third Injection
|
126.3 mIU/mL
Interval 49.5 to 203.2
|
524.5 mIU/mL
Interval 109.3 to 939.7
|
0.3 mIU/mL
Interval 0.2 to 0.5
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 before the third injectionThe measurements of anti-HBs antibodies were determined quantitatively by CMIA. The accepted protective serum anti-HBs level was ≥10 mIU/ml.
Outcome measures
| Measure |
IM20 Group
n=155 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=150 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=151 Participants
Participants received no intervention
|
|---|---|---|---|
|
Number and Rate of Participants With Anti-HBs Seroconversion at Month 6 Before the Third Injection
|
98 Participants
|
109 Participants
|
0 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Month 6 before the third injectionThe measurements of anti-HBs antibodies were determined quantitatively by CMIA. and anti-HBs concentrations ≥100 mIU/ml were high-level response.
Outcome measures
| Measure |
IM20 Group
n=155 Participants
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=150 Participants
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
Blank Control Group
n=151 Participants
Participants received no intervention
|
|---|---|---|---|
|
Number and Rate of Participants With Anti-HBs High-level Response at Month 6 Before the Third Injection
|
27 Participants
|
44 Participants
|
0 Participants
|
Adverse Events
IM20 Group
IM60 Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
IM20 Group
n=158 participants at risk
Participants received 3 intramuscular injections of 20 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
IM60 Group
n=156 participants at risk
Participants received 3 intramuscular injections of 60 μg recombinant hepatitis B vaccine at months 0, 1 and 6.
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
erytherma
|
5.1%
8/158
The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
|
5.8%
9/156
The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
|
|
Musculoskeletal and connective tissue disorders
pain
|
6.3%
10/158
The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
|
5.8%
9/156
The blank control group was not vaccinated with hepatitis B vaccine, so adverse reactions of hepatitis B vaccine were not collected and analyzed.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place