Trial Outcomes & Findings for A Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants (NCT NCT05217641)
NCT ID: NCT05217641
Last Updated: 2025-10-14
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE1
Target enrollment
108 participants
Primary outcome timeframe
Measured through 7 days after each vaccine dose
Results posted on
2025-10-14
Participant Flow
Participant milestones
| Measure |
Part B, Group 6: Treatment
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
18
|
18
|
19
|
17
|
18
|
18
|
|
Overall Study
COMPLETED
|
18
|
16
|
17
|
17
|
14
|
14
|
|
Overall Study
NOT COMPLETED
|
0
|
2
|
2
|
0
|
4
|
4
|
Reasons for withdrawal
| Measure |
Part B, Group 6: Treatment
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part A, Group 1: Treatment
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
250 mcg of BG505 MD39.3 gp151 mRNA
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
1
|
0
|
1
|
1
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
3
|
1
|
|
Overall Study
Other: participant did not specify reason
|
0
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Extended Follow up
|
0
|
1
|
1
|
0
|
0
|
1
|
Baseline Characteristics
A Clinical Trial to Evaluate the Safety and Immunogenicity of BG505 MD39.3, BG505 MD39.3 gp151, and BG505 MD39.3 gp151 CD4KO HIV Trimer mRNA Vaccines in Healthy, HIV-uninfected Adult Participants
Baseline characteristics by cohort
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Total
n=108 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
25.5 years
n=99 Participants
|
35 years
n=107 Participants
|
31 years
n=206 Participants
|
27 years
n=7 Participants
|
26 years
n=31 Participants
|
30 years
n=30 Participants
|
28.5 years
n=3 Participants
|
|
Age, Customized
18 - 20 years
|
3 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
12 Participants
n=3 Participants
|
|
Age, Customized
21 - 30 years
|
10 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
51 Participants
n=3 Participants
|
|
Age, Customized
31 - 40 years
|
4 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
5 Participants
n=30 Participants
|
32 Participants
n=3 Participants
|
|
Age, Customized
41 - 50 years
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
10 Participants
n=3 Participants
|
|
Age, Customized
Over 50 years
|
0 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Sex: Female, Male
Female
|
12 Participants
n=99 Participants
|
10 Participants
n=107 Participants
|
7 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=31 Participants
|
7 Participants
n=30 Participants
|
52 Participants
n=3 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
9 Participants
n=7 Participants
|
11 Participants
n=31 Participants
|
11 Participants
n=30 Participants
|
56 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=31 Participants
|
3 Participants
n=30 Participants
|
18 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
10 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
90 Participants
n=3 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
2 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=30 Participants
|
3 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=30 Participants
|
15 Participants
n=3 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
13 Participants
n=206 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
15 Participants
n=30 Participants
|
84 Participants
n=3 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
4 Participants
n=3 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=30 Participants
|
0 Participants
n=3 Participants
|
|
Region of Enrollment
US
|
18 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
18 Participants
n=7 Participants
|
18 Participants
n=31 Participants
|
18 Participants
n=30 Participants
|
108 Participants
n=3 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine doseGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
None
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Mild
|
10 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Moderate
|
8 Participants
|
10 Participants
|
4 Participants
|
8 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Solicited Adverse Events Signs and Symptoms: Pain and/or Tenderness
Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine doseGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
17 Participants
|
13 Participants
|
16 Participants
|
16 Participants
|
15 Participants
|
12 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Moderate
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
16 Participants
|
15 Participants
|
12 Participants
|
14 Participants
|
17 Participants
|
14 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Moderate
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
15 Participants
|
13 Participants
|
12 Participants
|
13 Participants
|
14 Participants
|
12 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Moderate
|
2 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Unsolicited Adverse Events Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine doseGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
2 Participants
|
7 Participants
|
2 Participants
|
3 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
11 Participants
|
6 Participants
|
7 Participants
|
6 Participants
|
8 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
5 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
8 Participants
|
12 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
5 Participants
|
11 Participants
|
5 Participants
|
7 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
8 Participants
|
3 Participants
|
7 Participants
|
3 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
5 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
8 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
4 Participants
|
6 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
11 Participants
|
8 Participants
|
10 Participants
|
11 Participants
|
10 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
14 Participants
|
16 Participants
|
9 Participants
|
11 Participants
|
9 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
4 Participants
|
1 Participants
|
5 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
7 Participants
|
13 Participants
|
6 Participants
|
11 Participants
|
2 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
8 Participants
|
2 Participants
|
8 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
3 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
10 Participants
|
10 Participants
|
5 Participants
|
11 Participants
|
8 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
6 Participants
|
7 Participants
|
7 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
2 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
10 Participants
|
9 Participants
|
7 Participants
|
8 Participants
|
3 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
7 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
11 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
5 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
14 Participants
|
13 Participants
|
17 Participants
|
17 Participants
|
12 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
4 Participants
|
5 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 8, 64, 176 and 225Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - ALT in U/L
ALT (U/L) -Screening
|
15 U/L
Interval 13.0 to 21.0
|
17 U/L
Interval 12.0 to 23.0
|
17 U/L
Interval 15.0 to 28.0
|
15 U/L
Interval 12.0 to 25.0
|
19 U/L
Interval 13.0 to 23.0
|
23 U/L
Interval 17.0 to 31.0
|
|
Chemistry and Hematology Laboratory Measures - ALT in U/L
ALT (U/L) -V3 - 1 week post-vaccination 1
|
14 U/L
Interval 11.0 to 19.0
|
16 U/L
Interval 14.0 to 25.0
|
17 U/L
Interval 13.0 to 32.0
|
14.5 U/L
Interval 14.0 to 30.0
|
14.5 U/L
Interval 12.0 to 20.0
|
20 U/L
Interval 17.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - ALT in U/L
ALT (U/L) -V7 - 1 week post-vaccination 2
|
13 U/L
Interval 12.0 to 16.0
|
17 U/L
Interval 13.0 to 22.5
|
17 U/L
Interval 12.0 to 31.0
|
14 U/L
Interval 12.0 to 19.0
|
15 U/L
Interval 11.0 to 19.0
|
22 U/L
Interval 17.5 to 35.5
|
|
Chemistry and Hematology Laboratory Measures - ALT in U/L
ALT (U/L) -V11 - 1 week post-Vaccination 3
|
12 U/L
Interval 11.0 to 18.0
|
13 U/L
Interval 10.0 to 19.0
|
13 U/L
Interval 12.0 to 29.0
|
12 U/L
Interval 10.0 to 17.0
|
13 U/L
Interval 12.0 to 17.0
|
19 U/L
Interval 15.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - ALT in U/L
ALT (U/L) -V14 - 8 weeks post-vaccination 3
|
—
|
—
|
—
|
28 U/L
Interval 28.0 to 28.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 8, 64, 176 and 225Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL) -Screening
|
0.82 mg/dL
Interval 0.66 to 0.89
|
0.91 mg/dL
Interval 0.79 to 1.05
|
0.87 mg/dL
Interval 0.8 to 0.91
|
0.79 mg/dL
Interval 0.68 to 0.91
|
0.91 mg/dL
Interval 0.76 to 0.98
|
0.86 mg/dL
Interval 0.73 to 0.94
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL) -V3 - 1 week post-vaccination 1
|
0.77 mg/dL
Interval 0.67 to 0.86
|
0.9 mg/dL
Interval 0.79 to 1.1
|
0.91 mg/dL
Interval 0.79 to 0.98
|
0.76 mg/dL
Interval 0.71 to 0.96
|
0.91 mg/dL
Interval 0.79 to 1.0
|
0.82 mg/dL
Interval 0.74 to 1.03
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL) -V7 - 1 week post-vaccination 2
|
0.8 mg/dL
Interval 0.71 to 0.86
|
1 mg/dL
Interval 0.86 to 1.09
|
0.84 mg/dL
Interval 0.8 to 0.93
|
0.76 mg/dL
Interval 0.68 to 0.88
|
0.9 mg/dL
Interval 0.82 to 0.96
|
0.87 mg/dL
Interval 0.76 to 0.95
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3
|
0.83 mg/dL
Interval 0.71 to 0.91
|
0.95 mg/dL
Interval 0.8 to 1.09
|
0.86 mg/dL
Interval 0.75 to 1.0
|
0.8 mg/dL
Interval 0.62 to 0.88
|
0.86 mg/dL
Interval 0.77 to 0.92
|
0.81 mg/dL
Interval 0.74 to 1.03
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3
|
—
|
—
|
—
|
0.83 mg/dL
Interval 0.83 to 0.83
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 8, 64, 176 and 225Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL) -Screening
|
14.55 g/dL
Interval 12.9 to 15.1
|
13.7 g/dL
Interval 12.9 to 15.6
|
14.2 g/dL
Interval 12.9 to 14.9
|
14.1 g/dL
Interval 13.4 to 15.0
|
14.75 g/dL
Interval 14.1 to 15.7
|
14.15 g/dL
Interval 13.2 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1
|
13.8 g/dL
Interval 12.9 to 14.4
|
13.8 g/dL
Interval 12.9 to 15.4
|
13.7 g/dL
Interval 12.7 to 14.5
|
13.85 g/dL
Interval 13.0 to 15.2
|
14.1 g/dL
Interval 13.8 to 15.1
|
13.8 g/dL
Interval 13.1 to 14.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2
|
13.5 g/dL
Interval 11.8 to 14.6
|
13.65 g/dL
Interval 12.6 to 14.85
|
13.4 g/dL
Interval 12.2 to 14.4
|
13.1 g/dL
Interval 12.6 to 13.8
|
13.8 g/dL
Interval 13.1 to 14.5
|
14 g/dL
Interval 12.45 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3
|
13.7 g/dL
Interval 11.9 to 14.4
|
13.5 g/dL
Interval 12.0 to 14.5
|
13.7 g/dL
Interval 12.3 to 14.2
|
12.9 g/dL
Interval 12.4 to 13.3
|
13.7 g/dL
Interval 12.9 to 14.5
|
13.2 g/dL
Interval 12.4 to 14.5
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3
|
13.7 g/dL
Interval 12.2 to 14.3
|
13.4 g/dL
Interval 11.7 to 14.3
|
13.9 g/dL
Interval 12.3 to 14.6
|
12.9 g/dL
Interval 11.7 to 13.5
|
13.7 g/dL
Interval 12.2 to 14.8
|
13.25 g/dL
Interval 12.65 to 14.5
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 8, 64, 176 and 225Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Basophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.05
|
0.05 1000 cells/Cubic mm
Interval 0.04 to 0.07
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.05
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.05
|
0.05 1000 cells/Cubic mm
Interval 0.02 to 0.07
|
0.03 1000 cells/Cubic mm
Interval 0.02 to 0.05
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Eosinophils (1000 cells/Cubic mm) -Screening
|
0.08 1000 cells/Cubic mm
Interval 0.05 to 0.1
|
0.11 1000 cells/Cubic mm
Interval 0.09 to 0.17
|
0.12 1000 cells/Cubic mm
Interval 0.06 to 0.16
|
0.11 1000 cells/Cubic mm
Interval 0.07 to 0.2
|
0.14 1000 cells/Cubic mm
Interval 0.1 to 0.22
|
0.12 1000 cells/Cubic mm
Interval 0.09 to 0.17
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Eosinophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1
|
0.16 1000 cells/Cubic mm
Interval 0.1 to 0.25
|
0.12 1000 cells/Cubic mm
Interval 0.1 to 0.17
|
0.18 1000 cells/Cubic mm
Interval 0.1 to 0.3
|
0.16 1000 cells/Cubic mm
Interval 0.12 to 0.28
|
0.21 1000 cells/Cubic mm
Interval 0.14 to 0.3
|
0.19 1000 cells/Cubic mm
Interval 0.1 to 0.3
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Eosinophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2
|
0.14 1000 cells/Cubic mm
Interval 0.07 to 0.21
|
0.13 1000 cells/Cubic mm
Interval 0.1 to 0.22
|
0.15 1000 cells/Cubic mm
Interval 0.11 to 0.25
|
0.17 1000 cells/Cubic mm
Interval 0.13 to 0.3
|
0.2 1000 cells/Cubic mm
Interval 0.15 to 0.26
|
0.19 1000 cells/Cubic mm
Interval 0.11 to 0.25
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/Cubic mm) -Screening
|
2.12 1000 cells/Cubic mm
Interval 1.78 to 2.36
|
1.93 1000 cells/Cubic mm
Interval 1.8 to 2.68
|
1.86 1000 cells/Cubic mm
Interval 1.55 to 2.1
|
2.05 1000 cells/Cubic mm
Interval 1.46 to 2.6
|
1.79 1000 cells/Cubic mm
Interval 1.56 to 2.18
|
1.78 1000 cells/Cubic mm
Interval 1.31 to 2.25
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1
|
2.02 1000 cells/Cubic mm
Interval 1.74 to 2.3
|
1.92 1000 cells/Cubic mm
Interval 1.6 to 2.57
|
1.85 1000 cells/Cubic mm
Interval 1.66 to 2.37
|
2.08 1000 cells/Cubic mm
Interval 1.65 to 2.48
|
1.9 1000 cells/Cubic mm
Interval 1.47 to 2.2
|
1.89 1000 cells/Cubic mm
Interval 1.64 to 2.09
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2
|
2.17 1000 cells/Cubic mm
Interval 1.68 to 2.5
|
2.08 1000 cells/Cubic mm
Interval 1.83 to 2.27
|
1.85 1000 cells/Cubic mm
Interval 1.62 to 2.19
|
2.1 1000 cells/Cubic mm
Interval 1.57 to 2.32
|
1.9 1000 cells/Cubic mm
Interval 1.66 to 2.45
|
1.87 1000 cells/Cubic mm
Interval 1.54 to 2.22
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3
|
2.02 1000 cells/Cubic mm
Interval 1.69 to 2.51
|
2.1 1000 cells/Cubic mm
Interval 1.69 to 2.53
|
1.85 1000 cells/Cubic mm
Interval 1.6 to 2.24
|
2.01 1000 cells/Cubic mm
Interval 1.92 to 2.2
|
2.02 1000 cells/Cubic mm
Interval 1.69 to 2.31
|
2.04 1000 cells/Cubic mm
Interval 1.81 to 2.21
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Lymphocytes (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3
|
1.79 1000 cells/Cubic mm
Interval 1.49 to 2.03
|
1.86 1000 cells/Cubic mm
Interval 1.56 to 2.14
|
1.78 1000 cells/Cubic mm
Interval 1.59 to 2.21
|
1.94 1000 cells/Cubic mm
Interval 1.69 to 2.18
|
2.13 1000 cells/Cubic mm
Interval 1.66 to 2.23
|
1.95 1000 cells/Cubic mm
Interval 1.73 to 2.16
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/Cubic mm) -Screening
|
4.26 1000 cells/Cubic mm
Interval 2.97 to 4.81
|
3.39 1000 cells/Cubic mm
Interval 2.66 to 4.28
|
3.9 1000 cells/Cubic mm
Interval 3.54 to 5.73
|
4.13 1000 cells/Cubic mm
Interval 3.42 to 5.4
|
3.31 1000 cells/Cubic mm
Interval 2.56 to 4.35
|
3.22 1000 cells/Cubic mm
Interval 2.31 to 5.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1
|
3.9 1000 cells/Cubic mm
Interval 2.81 to 4.65
|
3.84 1000 cells/Cubic mm
Interval 2.77 to 5.14
|
3.53 1000 cells/Cubic mm
Interval 2.91 to 4.93
|
3.33 1000 cells/Cubic mm
Interval 2.45 to 4.9
|
3.44 1000 cells/Cubic mm
Interval 2.88 to 4.21
|
3.59 1000 cells/Cubic mm
Interval 2.66 to 4.3
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2
|
3.54 1000 cells/Cubic mm
Interval 3.02 to 4.4
|
3.07 1000 cells/Cubic mm
Interval 2.8 to 4.05
|
3.07 1000 cells/Cubic mm
Interval 2.52 to 3.9
|
3.37 1000 cells/Cubic mm
Interval 2.66 to 4.24
|
2.73 1000 cells/Cubic mm
Interval 2.21 to 3.56
|
2.86 1000 cells/Cubic mm
Interval 2.25 to 4.38
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3
|
3.09 1000 cells/Cubic mm
Interval 2.43 to 4.76
|
3.18 1000 cells/Cubic mm
Interval 2.34 to 4.65
|
3.67 1000 cells/Cubic mm
Interval 2.4 to 4.89
|
3.2 1000 cells/Cubic mm
Interval 2.4 to 3.79
|
2.8 1000 cells/Cubic mm
Interval 1.99 to 3.38
|
3.18 1000 cells/Cubic mm
Interval 2.89 to 3.64
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Neutrophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3
|
3.5 1000 cells/Cubic mm
Interval 3.29 to 4.91
|
3.76 1000 cells/Cubic mm
Interval 3.37 to 5.65
|
3.6 1000 cells/Cubic mm
Interval 2.93 to 5.31
|
3.01 1000 cells/Cubic mm
Interval 2.62 to 3.79
|
2.73 1000 cells/Cubic mm
Interval 2.11 to 4.77
|
3.42 1000 cells/Cubic mm
Interval 3.22 to 4.71
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Basophils (1000 cells/Cubic mm) -Screening
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.06
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.07
|
0.05 1000 cells/Cubic mm
Interval 0.03 to 0.05
|
0.05 1000 cells/Cubic mm
Interval 0.04 to 0.07
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.07
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.06
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Basophils (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1
|
0.04 1000 cells/Cubic mm
Interval 0.04 to 0.06
|
0.05 1000 cells/Cubic mm
Interval 0.03 to 0.07
|
0.05 1000 cells/Cubic mm
Interval 0.04 to 0.07
|
0.05 1000 cells/Cubic mm
Interval 0.03 to 0.06
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.05
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.05
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Basophils (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.06
|
0.05 1000 cells/Cubic mm
Interval 0.04 to 0.06
|
0.05 1000 cells/Cubic mm
Interval 0.03 to 0.06
|
0.04 1000 cells/Cubic mm
Interval 0.02 to 0.05
|
0.05 1000 cells/Cubic mm
Interval 0.03 to 0.07
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.05
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Basophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3
|
0.05 1000 cells/Cubic mm
Interval 0.04 to 0.06
|
0.06 1000 cells/Cubic mm
Interval 0.04 to 0.06
|
0.05 1000 cells/Cubic mm
Interval 0.04 to 0.07
|
0.05 1000 cells/Cubic mm
Interval 0.03 to 0.06
|
0.05 1000 cells/Cubic mm
Interval 0.03 to 0.07
|
0.04 1000 cells/Cubic mm
Interval 0.03 to 0.06
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Eosinophils (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3
|
0.11 1000 cells/Cubic mm
Interval 0.09 to 0.18
|
0.15 1000 cells/Cubic mm
Interval 0.11 to 0.18
|
0.13 1000 cells/Cubic mm
Interval 0.1 to 0.2
|
0.11 1000 cells/Cubic mm
Interval 0.1 to 0.26
|
0.2 1000 cells/Cubic mm
Interval 0.17 to 0.38
|
0.14 1000 cells/Cubic mm
Interval 0.1 to 0.21
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil, Basophils, Eosinophils Count in 1000 Cells/Cubic mm
Eosinophils (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3
|
0.1 1000 cells/Cubic mm
Interval 0.07 to 0.13
|
0.11 1000 cells/Cubic mm
Interval 0.07 to 0.17
|
0.13 1000 cells/Cubic mm
Interval 0.11 to 0.19
|
0.13 1000 cells/Cubic mm
Interval 0.07 to 0.22
|
0.18 1000 cells/Cubic mm
Interval 0.12 to 0.26
|
0.11 1000 cells/Cubic mm
Interval 0.08 to 0.15
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 8, 64, 176 and 225Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/Cubic mm) -Screening
|
7.05 1000 cells/Cubic mm
Interval 5.46 to 7.78
|
6.23 1000 cells/Cubic mm
Interval 5.41 to 6.47
|
6.76 1000 cells/Cubic mm
Interval 6.08 to 8.17
|
7.1 1000 cells/Cubic mm
Interval 6.0 to 8.5
|
5.82 1000 cells/Cubic mm
Interval 4.91 to 7.5
|
6.25 1000 cells/Cubic mm
Interval 4.3 to 8.36
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1
|
6.45 1000 cells/Cubic mm
Interval 5.63 to 7.86
|
6.7 1000 cells/Cubic mm
Interval 5.1 to 7.7
|
6.7 1000 cells/Cubic mm
Interval 5.6 to 8.36
|
6.17 1000 cells/Cubic mm
Interval 5.4 to 7.36
|
6.09 1000 cells/Cubic mm
Interval 5.0 to 7.1
|
6.14 1000 cells/Cubic mm
Interval 5.1 to 7.22
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2
|
6.17 1000 cells/Cubic mm
Interval 5.5 to 8.33
|
5.79 1000 cells/Cubic mm
Interval 5.15 to 7.2
|
5.65 1000 cells/Cubic mm
Interval 5.19 to 6.22
|
6.64 1000 cells/Cubic mm
Interval 5.1 to 7.0
|
5.7 1000 cells/Cubic mm
Interval 4.44 to 6.8
|
5.43 1000 cells/Cubic mm
Interval 4.54 to 7.3
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3
|
5.59 1000 cells/Cubic mm
Interval 4.95 to 7.42
|
6.21 1000 cells/Cubic mm
Interval 5.25 to 7.12
|
6.64 1000 cells/Cubic mm
Interval 5.1 to 7.69
|
6 1000 cells/Cubic mm
Interval 5.1 to 6.7
|
5.49 1000 cells/Cubic mm
Interval 4.3 to 6.3
|
5.9 1000 cells/Cubic mm
Interval 5.7 to 7.6
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
WBC (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3
|
5.99 1000 cells/Cubic mm
Interval 5.6 to 7.3
|
6.49 1000 cells/Cubic mm
Interval 5.08 to 7.8
|
6.1 1000 cells/Cubic mm
Interval 5.12 to 7.84
|
5.91 1000 cells/Cubic mm
Interval 4.96 to 6.6
|
5.71 1000 cells/Cubic mm
Interval 4.75 to 8.53
|
6.26 1000 cells/Cubic mm
Interval 5.65 to 7.42
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/Cubic mm) -Screening
|
257 1000 cells/Cubic mm
Interval 223.0 to 282.0
|
267 1000 cells/Cubic mm
Interval 249.0 to 330.0
|
284 1000 cells/Cubic mm
Interval 237.0 to 325.0
|
276 1000 cells/Cubic mm
Interval 261.0 to 299.0
|
257.5 1000 cells/Cubic mm
Interval 208.0 to 308.0
|
259 1000 cells/Cubic mm
Interval 222.0 to 305.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/Cubic mm) -V3 - 1 week post-vaccination 1
|
251 1000 cells/Cubic mm
Interval 216.0 to 306.0
|
277 1000 cells/Cubic mm
Interval 254.0 to 342.0
|
287 1000 cells/Cubic mm
Interval 236.0 to 331.0
|
283.5 1000 cells/Cubic mm
Interval 244.0 to 316.0
|
256.5 1000 cells/Cubic mm
Interval 217.0 to 321.0
|
281 1000 cells/Cubic mm
Interval 240.0 to 292.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/Cubic mm) -V7 - 1 week post-vaccination 2
|
271 1000 cells/Cubic mm
Interval 244.0 to 305.0
|
285.5 1000 cells/Cubic mm
Interval 238.5 to 349.0
|
267 1000 cells/Cubic mm
Interval 232.0 to 306.0
|
279 1000 cells/Cubic mm
Interval 264.0 to 288.0
|
262 1000 cells/Cubic mm
Interval 237.0 to 352.0
|
278 1000 cells/Cubic mm
Interval 240.0 to 309.5
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/Cubic mm) -V11 - 1 week post-Vaccination 3
|
267.3 1000 cells/Cubic mm
Interval 228.5 to 294.0
|
269 1000 cells/Cubic mm
Interval 250.0 to 341.0
|
275 1000 cells/Cubic mm
Interval 256.0 to 326.0
|
295 1000 cells/Cubic mm
Interval 267.0 to 319.0
|
271 1000 cells/Cubic mm
Interval 239.0 to 367.0
|
274 1000 cells/Cubic mm
Interval 249.0 to 312.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000 Cells/Cubic mm
Platelets (1000 cells/Cubic mm) -V14 - 8 weeks post-vaccination 3
|
290 1000 cells/Cubic mm
Interval 232.0 to 327.0
|
277 1000 cells/Cubic mm
Interval 242.0 to 325.3
|
279 1000 cells/Cubic mm
Interval 255.0 to 314.0
|
271.5 1000 cells/Cubic mm
Interval 247.0 to 315.0
|
291 1000 cells/Cubic mm
Interval 214.0 to 351.0
|
281 1000 cells/Cubic mm
Interval 249.0 to 316.0
|
PRIMARY outcome
Timeframe: Measured during Screening, Days 8, 64, 176 and 225Population: 'Overall Number of Participants Analyzed' represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC), basophils, eosinophils was summarized by arm
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Basophils (1000/cubic mm) -V7 - 1 week post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Basophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Basophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Eosinophils (1000/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Eosinophils (1000/cubic mm) -V3 - 1 week post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Eosinophils (1000/cubic mm) -V7 - 1 week post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Eosinophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Eosinophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
ALT (U/L) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
ALT (U/L) -V3 - 1 week post-vaccination 1
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
ALT (U/L) -V7 - 1 week post-vaccination 2
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
ALT (U/L) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
ALT (U/L) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Hemoglobin (g/dL) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Hemoglobin (g/dL) -V3 - 1 week post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Hemoglobin (g/dL) -V7 - 1 week post-vaccination 2
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Hemoglobin (g/dL) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Hemoglobin (g/dL) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Creatinine (mg/dL) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Creatinine (mg/dL) -V3 - 1 week post-vaccination 1
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Creatinine (mg/dL) -V7 - 1 week post-vaccination 2
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Creatinine (mg/dL) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Creatinine (mg/dL) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
WBC (1000/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
WBC (1000/cubic mm) -V3 - 1 week post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
WBC (1000/cubic mm) -V7 - 1 week post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
WBC (1000/cubic mm) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
WBC (1000/cubic mm) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Platelets (1000/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Platelets (1000/cubic mm) -V3 - 1 week post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Platelets (1000/cubic mm) -V7 - 1 week post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Platelets (1000/cubic mm) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Platelets (1000/cubic mm) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Lymphocytes (1000/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Lymphocytes (1000/cubic mm) -V3 - 1 week post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Lymphocytes (1000/cubic mm) -V7 - 1 week post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Lymphocytes (1000/cubic mm) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Lymphocytes (1000/cubic mm) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Neutrophils (1000/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Neutrophils (1000/cubic mm) -V3 - 1 week post-vaccination 1
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Neutrophils (1000/cubic mm) -V7 - 1 week post-vaccination 2
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Neutrophils (1000/cubic mm) -V11 - 1 week post-Vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Neutrophils (1000/cubic mm) -V14 - 8 weeks post-vaccination 3
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Basophils (1000/cubic mm) -Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Lab Grade > 1 for ALT, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC), Basophils, Eosinophils
Basophils (1000/cubic mm) -V3 - 1 week post-vaccination 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days following each injectionPopulation: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
No AE reported
|
2 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Mild
|
6 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
3 Participants
|
8 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Moderate
|
10 Participants
|
9 Participants
|
9 Participants
|
9 Participants
|
5 Participants
|
5 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Severe
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Death
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 30 days following each injectionPopulation: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply).
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Related
|
8 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Not Related
|
8 Participants
|
12 Participants
|
11 Participants
|
12 Participants
|
5 Participants
|
10 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
No AE reported
|
2 Participants
|
5 Participants
|
4 Participants
|
3 Participants
|
10 Participants
|
4 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Medically Attended Adverse Events (MAAEs)
|
9 Participants
|
9 Participants
|
8 Participants
|
6 Participants
|
5 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12.Population: Safety population
There were no adverse events of special interest reported by any participant.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12Population: Safety population
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017 (exceptions apply)
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Adverse event
|
2 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity symptom
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Other reason
|
0 Participants
|
2 Participants
|
0 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
No Discontinuation
|
16 Participants
|
16 Participants
|
17 Participants
|
9 Participants
|
14 Participants
|
16 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 12.Population: Safety population
There were no early study terminations associated with an AE or reactogenicity reported by any participant.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: 2 weeks after the 3rd vaccination timepoint (M6.5)Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 50, M6.5
|
5 log10(titer)
Interval 5.0 to 5.0
|
15.5 log10(titer)
Interval 5.0 to 43.6
|
35.4 log10(titer)
Interval 9.1 to 115.7
|
5 log10(titer)
Interval 5.0 to 5.0
|
73.4 log10(titer)
Interval 22.3 to 218.9
|
68.6 log10(titer)
Interval 53.2 to 348.4
|
|
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 80, M6.5
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 13.7
|
9.6 log10(titer)
Interval 5.0 to 30.9
|
5 log10(titer)
Interval 5.0 to 5.0
|
22.5 log10(titer)
Interval 7.0 to 69.4
|
24.8 log10(titer)
Interval 15.9 to 143.3
|
PRIMARY outcome
Timeframe: 2 weeks after the 3rd vaccination timepoint (M6.5)Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 50, M6.5
|
0 Participants
|
11 Participants
|
12 Participants
|
1 Participants
|
12 Participants
|
16 Participants
|
|
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 80, M6.5
|
0 Participants
|
7 Participants
|
8 Participants
|
0 Participants
|
10 Participants
|
14 Participants
|
SECONDARY outcome
Timeframe: 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 50, M2.5
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 23.8
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 13.1
|
5 log10(titer)
Interval 5.0 to 5.0
|
|
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 50, M12
|
—
|
27.6 log10(titer)
Interval 20.7 to 47.9
|
49 log10(titer)
Interval 43.3 to 69.7
|
—
|
76.4 log10(titer)
Interval 36.5 to 167.2
|
67.5 log10(titer)
Interval 37.6 to 334.7
|
|
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 80, M2.5
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 5.0
|
5 log10(titer)
Interval 5.0 to 5.0
|
|
Magnitude of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 80, M12
|
—
|
5 log10(titer)
Interval 5.0 to 12.0
|
12.7 log10(titer)
Interval 6.6 to 18.3
|
—
|
22.1 log10(titer)
Interval 11.2 to 22.9
|
16.8 log10(titer)
Interval 13.8 to 57.3
|
SECONDARY outcome
Timeframe: 2 weeks after the 2nd vaccination (M2.5), 6 months after the 3rd vaccination (M12)Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available NAb data after filtering for assay specific quality control criteria.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay performed in TZM-bl cells measured neutralization titers against a panel of autologous and Env-pseudotyped viruses that exhibit tier 2 neutralization phenotype: BG505/T332N.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 50, M2.5
|
0 Participants
|
2 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 50, M12
|
0 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
8 Participants
|
9 Participants
|
|
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 80, M12
|
0 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
|
Response Rate of Serum Antibody Neutralization of a Vaccine-matched Tier 2 HIV-1 Strain
BG505/T332N, 1: 80, M2.5
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination, 2 weeks after the 3rd vaccination, and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI\* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI\*), 2) MFI\* \> 3x(Visit 2 MFI\* ), and 3) MFI \> 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI\* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank\>5000 MFI), high baseline (Baseline\>6500 MFI\*) are excluded. MFI\* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Link14_peptide_biotin, 1: 50, M12
|
222.25 Relative fluorescence units
Interval 95.0 to 977.75
|
113.75 Relative fluorescence units
Interval 68.75 to 406.25
|
136.25 Relative fluorescence units
Interval 86.5 to 414.0
|
1258.5 Relative fluorescence units
Interval 498.0 to 1556.0
|
182 Relative fluorescence units
Interval 101.25 to 423.62
|
189.75 Relative fluorescence units
Interval 103.88 to 358.12
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5
|
1 Relative fluorescence units
Interval 1.0 to 65.38
|
1 Relative fluorescence units
Interval 1.0 to 38.5
|
1 Relative fluorescence units
Interval 1.0 to 159.75
|
13.25 Relative fluorescence units
Interval 1.0 to 147.25
|
35.5 Relative fluorescence units
Interval 1.0 to 356.25
|
50.62 Relative fluorescence units
Interval 6.06 to 431.56
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5
|
60.75 Relative fluorescence units
Interval 1.0 to 887.5
|
259.75 Relative fluorescence units
Interval 10.5 to 484.0
|
121 Relative fluorescence units
Interval 1.0 to 534.19
|
48.88 Relative fluorescence units
Interval 26.44 to 343.62
|
1527.75 Relative fluorescence units
Interval 504.75 to 2062.38
|
917.75 Relative fluorescence units
Interval 226.5 to 1802.75
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
TT31P.2792_D11gp120.avi/293F, 1: 50, M12
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
2 Relative fluorescence units
Interval 1.0 to 29.75
|
8 Relative fluorescence units
Interval 1.0 to 32.25
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
37.5 Relative fluorescence units
Interval 1.38 to 75.38
|
8.63 Relative fluorescence units
Interval 1.0 to 58.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
gp41, 1: 50, M2.5
|
619.12 Relative fluorescence units
Interval 400.12 to 1077.06
|
435.75 Relative fluorescence units
Interval 165.75 to 1014.5
|
400.62 Relative fluorescence units
Interval 132.0 to 791.0
|
1374.25 Relative fluorescence units
Interval 656.5 to 1881.25
|
749.25 Relative fluorescence units
Interval 449.75 to 1086.5
|
786.88 Relative fluorescence units
Interval 532.0 to 1475.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
gp41, 1: 50, M6.5
|
989 Relative fluorescence units
Interval 748.38 to 2367.56
|
1578.75 Relative fluorescence units
Interval 904.0 to 1666.75
|
1455 Relative fluorescence units
Interval 658.94 to 2155.0
|
2305.25 Relative fluorescence units
Interval 1630.5 to 4427.44
|
1421.12 Relative fluorescence units
Interval 822.19 to 2716.62
|
1348.25 Relative fluorescence units
Interval 939.25 to 2433.75
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
gp41, 1: 50, M12
|
1020.25 Relative fluorescence units
Interval 862.75 to 2139.5
|
1378.5 Relative fluorescence units
Interval 895.25 to 1755.5
|
1016.5 Relative fluorescence units
Interval 734.5 to 1308.12
|
2721.75 Relative fluorescence units
Interval 1422.62 to 3349.75
|
907.5 Relative fluorescence units
Interval 635.25 to 1945.25
|
1713.75 Relative fluorescence units
Interval 861.38 to 2506.12
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
scrambled_MD39_peptide-biotin, 1: 50, M2.5
|
184 Relative fluorescence units
Interval 140.5 to 1433.25
|
229 Relative fluorescence units
Interval 59.0 to 630.0
|
277.5 Relative fluorescence units
Interval 145.5 to 417.75
|
593.5 Relative fluorescence units
Interval 329.75 to 1083.5
|
549.75 Relative fluorescence units
Interval 71.5 to 794.62
|
454.5 Relative fluorescence units
Interval 94.75 to 843.75
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
254008_D11gp120.avi/293F, 1: 50, M12
|
1 Relative fluorescence units
Interval 1.0 to 3.75
|
1 Relative fluorescence units
Interval 1.0 to 31.0
|
8.75 Relative fluorescence units
Interval 1.0 to 25.5
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
61 Relative fluorescence units
Interval 1.63 to 191.12
|
4.5 Relative fluorescence units
Interval 1.0 to 91.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
scrambled_MD39_peptide-biotin, 1: 50, M6.5
|
245.12 Relative fluorescence units
Interval 152.5 to 1823.62
|
346.25 Relative fluorescence units
Interval 194.75 to 795.25
|
423.38 Relative fluorescence units
Interval 287.69 to 1141.25
|
863.62 Relative fluorescence units
Interval 484.81 to 1769.25
|
538.5 Relative fluorescence units
Interval 103.75 to 762.0
|
477.5 Relative fluorescence units
Interval 95.25 to 1049.12
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
scrambled_MD39_peptide-biotin, 1: 50, M12
|
255.5 Relative fluorescence units
Interval 156.0 to 1484.25
|
398.75 Relative fluorescence units
Interval 250.0 to 942.75
|
522.75 Relative fluorescence units
Interval 220.0 to 1130.75
|
720 Relative fluorescence units
Interval 548.25 to 1680.5
|
709.75 Relative fluorescence units
Interval 174.5 to 981.0
|
437.5 Relative fluorescence units
Interval 198.0 to 936.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
51802_D11gp120.avi/293F, 1: 50, M2.5
|
1 Relative fluorescence units
Interval 1.0 to 19.62
|
1 Relative fluorescence units
Interval 1.0 to 10.0
|
4.25 Relative fluorescence units
Interval 1.0 to 29.25
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
1 Relative fluorescence units
Interval 1.0 to 54.0
|
8.38 Relative fluorescence units
Interval 1.0 to 70.31
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
51802_D11gp120.avi/293F, 1: 50, M6.5
|
1 Relative fluorescence units
Interval 1.0 to 10.31
|
20 Relative fluorescence units
Interval 1.0 to 168.75
|
21.62 Relative fluorescence units
Interval 1.0 to 50.69
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
118.75 Relative fluorescence units
Interval 2.63 to 375.62
|
99.5 Relative fluorescence units
Interval 1.0 to 314.75
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
51802_D11gp120.avi/293F, 1: 50, M12
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
1 Relative fluorescence units
Interval 1.0 to 31.88
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
A244 D11gp120_avi, 1: 50, M2.5
|
46.5 Relative fluorescence units
Interval 6.13 to 292.75
|
10.5 Relative fluorescence units
Interval 1.0 to 131.5
|
11.25 Relative fluorescence units
Interval 1.0 to 190.25
|
19 Relative fluorescence units
Interval 1.0 to 420.0
|
74.5 Relative fluorescence units
Interval 4.0 to 317.25
|
92.75 Relative fluorescence units
Interval 54.25 to 689.81
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
A244 D11gp120_avi, 1: 50, M6.5
|
303.62 Relative fluorescence units
Interval 129.69 to 696.06
|
180.25 Relative fluorescence units
Interval 42.25 to 964.75
|
199 Relative fluorescence units
Interval 19.81 to 403.19
|
135 Relative fluorescence units
Interval 31.44 to 196.69
|
1482.25 Relative fluorescence units
Interval 362.62 to 3138.0
|
784.5 Relative fluorescence units
Interval 237.25 to 2758.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
A244 D11gp120_avi, 1: 50, M12
|
1 Relative fluorescence units
Interval 1.0 to 6.5
|
10.75 Relative fluorescence units
Interval 1.0 to 78.0
|
17 Relative fluorescence units
Interval 1.0 to 46.75
|
1 Relative fluorescence units
Interval 1.0 to 60.0
|
59.75 Relative fluorescence units
Interval 6.38 to 144.88
|
33.12 Relative fluorescence units
Interval 11.75 to 69.56
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
B.6240_D11gp120/293F, 1: 50, M2.5
|
8 Relative fluorescence units
Interval 1.0 to 223.62
|
3.5 Relative fluorescence units
Interval 1.0 to 49.25
|
3.75 Relative fluorescence units
Interval 1.0 to 320.0
|
1 Relative fluorescence units
Interval 1.0 to 33.0
|
39.5 Relative fluorescence units
Interval 1.0 to 204.5
|
37.25 Relative fluorescence units
Interval 1.0 to 348.94
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
B.6240_D11gp120/293F, 1: 50, M6.5
|
78.62 Relative fluorescence units
Interval 1.0 to 379.69
|
133.25 Relative fluorescence units
Interval 4.0 to 624.5
|
40.38 Relative fluorescence units
Interval 1.0 to 261.94
|
68.62 Relative fluorescence units
Interval 14.94 to 308.44
|
884.5 Relative fluorescence units
Interval 328.5 to 2199.5
|
670.5 Relative fluorescence units
Interval 167.5 to 2081.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
B.6240_D11gp120/293F, 1: 50, M12
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
1 Relative fluorescence units
Interval 1.0 to 12.75
|
1 Relative fluorescence units
Interval 1.0 to 7.75
|
1 Relative fluorescence units
Interval 1.0 to 10.0
|
13.75 Relative fluorescence units
Interval 1.0 to 166.5
|
1 Relative fluorescence units
Interval 1.0 to 13.94
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3, 1: 50, M2.5
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 20364.25 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 20303.38 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3, 1: 50, M6.5
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 17368.62 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3, 1: 50, M12
|
21533.75 Relative fluorescence units
Interval 14509.81 to 22000.0
|
13674.5 Relative fluorescence units
Interval 9269.75 to 18157.5
|
18339 Relative fluorescence units
Interval 8464.81 to 20661.12
|
22000 Relative fluorescence units
Interval 15919.5 to 22000.0
|
21657 Relative fluorescence units
Interval 15333.5 to 22000.0
|
20110.88 Relative fluorescence units
Interval 11982.19 to 21963.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4, 1: 50, M2.5
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4, 1: 50, M6.5
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 21908.25 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4, 1: 50, M12
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 18783.5 to 22000.0
|
22000 Relative fluorescence units
Interval 17454.88 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 21889.25 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5
|
16254.25 Relative fluorescence units
Interval 12636.88 to 20457.88
|
11775.5 Relative fluorescence units
Interval 9941.25 to 15384.0
|
12404.5 Relative fluorescence units
Interval 11145.0 to 16712.25
|
15431.75 Relative fluorescence units
Interval 10832.0 to 20131.0
|
15472.25 Relative fluorescence units
Interval 12399.75 to 18047.75
|
15092.38 Relative fluorescence units
Interval 9712.5 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5
|
20013.5 Relative fluorescence units
Interval 15814.69 to 22000.0
|
19060.5 Relative fluorescence units
Interval 15452.0 to 22000.0
|
20087.62 Relative fluorescence units
Interval 14704.69 to 22000.0
|
17648.12 Relative fluorescence units
Interval 4395.5 to 22000.0
|
22000 Relative fluorescence units
Interval 21866.5 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12
|
5045.25 Relative fluorescence units
Interval 3281.56 to 7325.0
|
6951.25 Relative fluorescence units
Interval 3752.75 to 8770.25
|
8530.12 Relative fluorescence units
Interval 3159.5 to 10593.5
|
5269.75 Relative fluorescence units
Interval 4347.94 to 6839.12
|
11112.25 Relative fluorescence units
Interval 6684.62 to 13390.88
|
10714.5 Relative fluorescence units
Interval 5377.44 to 12897.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5
|
12200.25 Relative fluorescence units
Interval 7355.38 to 15692.88
|
10560.75 Relative fluorescence units
Interval 4591.5 to 18965.0
|
16989.5 Relative fluorescence units
Interval 11869.0 to 20986.75
|
13412.5 Relative fluorescence units
Interval 9731.25 to 17226.5
|
22000 Relative fluorescence units
Interval 17147.5 to 22000.0
|
22000 Relative fluorescence units
Interval 19720.19 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5
|
21770.38 Relative fluorescence units
Interval 18509.38 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
19996 Relative fluorescence units
Interval 5802.75 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12
|
4398 Relative fluorescence units
Interval 2621.75 to 5618.25
|
6428.75 Relative fluorescence units
Interval 4436.0 to 14442.5
|
6688.5 Relative fluorescence units
Interval 3001.0 to 15936.75
|
2861.75 Relative fluorescence units
Interval 2318.0 to 4886.25
|
19599.75 Relative fluorescence units
Interval 7208.5 to 22000.0
|
22000 Relative fluorescence units
Interval 14025.25 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5
|
16300.75 Relative fluorescence units
Interval 11904.88 to 20198.38
|
11121.25 Relative fluorescence units
Interval 8643.75 to 15120.75
|
11629 Relative fluorescence units
Interval 10107.25 to 15439.75
|
15360.5 Relative fluorescence units
Interval 10514.5 to 20268.25
|
13386.5 Relative fluorescence units
Interval 11705.25 to 16777.5
|
14496.62 Relative fluorescence units
Interval 8994.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5
|
19182.5 Relative fluorescence units
Interval 16040.38 to 22000.0
|
18484.75 Relative fluorescence units
Interval 15080.0 to 22000.0
|
19112.5 Relative fluorescence units
Interval 12667.75 to 22000.0
|
17901.5 Relative fluorescence units
Interval 3917.62 to 22000.0
|
22000 Relative fluorescence units
Interval 21086.38 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_baseKO_1CCv4, 1: 50, M12
|
4491.62 Relative fluorescence units
Interval 2907.5 to 6424.19
|
5787.5 Relative fluorescence units
Interval 3354.5 to 7598.75
|
7891.62 Relative fluorescence units
Interval 2800.38 to 10132.44
|
4480.25 Relative fluorescence units
Interval 3464.75 to 5481.0
|
10265 Relative fluorescence units
Interval 6073.62 to 12169.75
|
9672 Relative fluorescence units
Interval 4632.19 to 11842.81
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
254008_D11gp120.avi/293F, 1: 50, M2.5
|
9.75 Relative fluorescence units
Interval 1.0 to 93.5
|
9.5 Relative fluorescence units
Interval 1.0 to 57.0
|
1 Relative fluorescence units
Interval 1.0 to 30.25
|
65.5 Relative fluorescence units
Interval 1.0 to 491.25
|
173 Relative fluorescence units
Interval 1.0 to 437.25
|
31.38 Relative fluorescence units
Interval 5.88 to 494.94
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_V3_peptide_biotin, 1: 50, M12
|
2088 Relative fluorescence units
Interval 903.12 to 7163.38
|
3303.25 Relative fluorescence units
Interval 1742.75 to 8927.25
|
2025.75 Relative fluorescence units
Interval 569.5 to 6822.5
|
2612.25 Relative fluorescence units
Interval 1977.75 to 4270.25
|
9554 Relative fluorescence units
Interval 4095.62 to 12290.5
|
6621.75 Relative fluorescence units
Interval 1675.5 to 13496.75
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BJOX002_D11gp120.avi/293F, 1: 50, M6.5
|
109.38 Relative fluorescence units
Interval 63.0 to 206.25
|
154.5 Relative fluorescence units
Interval 35.25 to 185.5
|
100.75 Relative fluorescence units
Interval 34.94 to 208.25
|
108 Relative fluorescence units
Interval 74.12 to 225.19
|
353 Relative fluorescence units
Interval 203.38 to 1214.75
|
278 Relative fluorescence units
Interval 102.25 to 1425.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Link14_peptide_biotin, 1: 50, M6.5
|
792.25 Relative fluorescence units
Interval 573.75 to 2124.38
|
309.5 Relative fluorescence units
Interval 108.25 to 1008.75
|
212.62 Relative fluorescence units
Interval 89.81 to 453.62
|
1896.12 Relative fluorescence units
Interval 1012.12 to 2339.56
|
488.75 Relative fluorescence units
Interval 154.38 to 818.5
|
281.88 Relative fluorescence units
Interval 94.06 to 499.88
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_pHLsecAvi, 1: 50, M2.5
|
9830.75 Relative fluorescence units
Interval 5910.12 to 12879.25
|
7920 Relative fluorescence units
Interval 4155.0 to 15617.0
|
14802.75 Relative fluorescence units
Interval 9432.5 to 17777.5
|
10246.5 Relative fluorescence units
Interval 7288.75 to 13637.0
|
21332.25 Relative fluorescence units
Interval 14163.5 to 22000.0
|
22000 Relative fluorescence units
Interval 17623.81 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_pHLsecAvi, 1: 50, M6.5
|
18019.75 Relative fluorescence units
Interval 14887.75 to 20101.12
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 21491.5 to 22000.0
|
15991.12 Relative fluorescence units
Interval 4274.25 to 20183.69
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 Relative fluorescence units
Interval 22000.0 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_pHLsecAvi, 1: 50, M12
|
3490.5 Relative fluorescence units
Interval 2451.75 to 5279.5
|
5952 Relative fluorescence units
Interval 4190.0 to 13786.25
|
6454.75 Relative fluorescence units
Interval 2743.75 to 15552.0
|
2791 Relative fluorescence units
Interval 2117.75 to 4520.75
|
19032 Relative fluorescence units
Interval 6850.38 to 22000.0
|
22000 Relative fluorescence units
Interval 13301.31 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_C1-113-125_biotin, 1: 50, M2.5
|
275 Relative fluorescence units
Interval 108.75 to 481.12
|
162.5 Relative fluorescence units
Interval 39.5 to 259.5
|
146.75 Relative fluorescence units
Interval 62.0 to 385.75
|
628 Relative fluorescence units
Interval 167.75 to 1148.25
|
291 Relative fluorescence units
Interval 65.25 to 929.25
|
185.5 Relative fluorescence units
Interval 76.75 to 468.75
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_C1-113-125_biotin, 1: 50, M6.5
|
300.88 Relative fluorescence units
Interval 102.94 to 676.62
|
285 Relative fluorescence units
Interval 107.5 to 517.5
|
217.62 Relative fluorescence units
Interval 96.44 to 952.88
|
896.88 Relative fluorescence units
Interval 567.19 to 1525.5
|
507.75 Relative fluorescence units
Interval 83.88 to 728.12
|
278.88 Relative fluorescence units
Interval 94.19 to 504.81
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_C1-113-125_biotin, 1: 50, M12
|
232.75 Relative fluorescence units
Interval 90.0 to 543.75
|
175 Relative fluorescence units
Interval 71.25 to 388.75
|
275 Relative fluorescence units
Interval 110.0 to 868.0
|
927.25 Relative fluorescence units
Interval 536.0 to 1675.5
|
286 Relative fluorescence units
Interval 83.5 to 733.0
|
222.5 Relative fluorescence units
Interval 122.0 to 447.38
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5
|
558.75 Relative fluorescence units
Interval 186.62 to 2608.12
|
240.5 Relative fluorescence units
Interval 147.0 to 1160.5
|
207.25 Relative fluorescence units
Interval 99.25 to 675.25
|
1836.25 Relative fluorescence units
Interval 554.25 to 2746.25
|
557.25 Relative fluorescence units
Interval 252.56 to 846.81
|
624.25 Relative fluorescence units
Interval 383.25 to 2053.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5
|
488.12 Relative fluorescence units
Interval 186.06 to 1544.88
|
466 Relative fluorescence units
Interval 224.0 to 2057.5
|
519.62 Relative fluorescence units
Interval 93.75 to 1598.19
|
1430.38 Relative fluorescence units
Interval 710.75 to 2019.0
|
545 Relative fluorescence units
Interval 315.56 to 864.94
|
458.62 Relative fluorescence units
Interval 333.56 to 2494.38
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-562-577_biotin, 1: 50, M12
|
385 Relative fluorescence units
Interval 254.5 to 1257.75
|
498.5 Relative fluorescence units
Interval 192.75 to 1508.0
|
546.75 Relative fluorescence units
Interval 119.25 to 1060.75
|
1213.5 Relative fluorescence units
Interval 496.75 to 1655.75
|
395 Relative fluorescence units
Interval 215.38 to 881.12
|
698.25 Relative fluorescence units
Interval 253.0 to 1878.38
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5
|
448.5 Relative fluorescence units
Interval 158.0 to 961.75
|
288.38 Relative fluorescence units
Interval 156.88 to 759.81
|
351.75 Relative fluorescence units
Interval 68.25 to 610.0
|
893.5 Relative fluorescence units
Interval 548.75 to 1389.0
|
583.25 Relative fluorescence units
Interval 207.0 to 981.5
|
455.25 Relative fluorescence units
Interval 220.5 to 1735.75
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5
|
781.62 Relative fluorescence units
Interval 206.75 to 1561.75
|
490 Relative fluorescence units
Interval 349.69 to 1903.31
|
506.38 Relative fluorescence units
Interval 191.12 to 2041.81
|
1372 Relative fluorescence units
Interval 774.75 to 1881.81
|
361.5 Relative fluorescence units
Interval 135.12 to 1203.75
|
499.12 Relative fluorescence units
Interval 171.88 to 4565.44
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-572-587_biotin, 1: 50, M12
|
191 Relative fluorescence units
Interval 144.0 to 1239.25
|
268.5 Relative fluorescence units
Interval 88.5 to 448.56
|
277.25 Relative fluorescence units
Interval 113.5 to 882.5
|
1048.25 Relative fluorescence units
Interval 531.5 to 1191.75
|
309.25 Relative fluorescence units
Interval 101.25 to 709.75
|
330.5 Relative fluorescence units
Interval 193.0 to 1745.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5
|
215 Relative fluorescence units
Interval 151.25 to 621.62
|
160 Relative fluorescence units
Interval 57.5 to 237.25
|
175.75 Relative fluorescence units
Interval 36.06 to 304.06
|
561 Relative fluorescence units
Interval 320.0 to 1064.75
|
202.5 Relative fluorescence units
Interval 46.25 to 501.0
|
201.5 Relative fluorescence units
Interval 80.5 to 522.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5
|
254.12 Relative fluorescence units
Interval 144.0 to 1160.06
|
259.75 Relative fluorescence units
Interval 88.25 to 488.75
|
134.75 Relative fluorescence units
Interval 56.75 to 383.75
|
537.5 Relative fluorescence units
Interval 462.44 to 1289.69
|
96.75 Relative fluorescence units
Interval 73.62 to 444.0
|
247.25 Relative fluorescence units
Interval 107.88 to 647.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12
|
237.75 Relative fluorescence units
Interval 171.25 to 1908.0
|
236.25 Relative fluorescence units
Interval 95.0 to 543.75
|
273.12 Relative fluorescence units
Interval 95.25 to 452.0
|
847.25 Relative fluorescence units
Interval 594.75 to 1293.5
|
249.75 Relative fluorescence units
Interval 89.62 to 607.62
|
400.25 Relative fluorescence units
Interval 180.38 to 557.38
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_V3_peptide_biotin, 1: 50, M2.5
|
13211.12 Relative fluorescence units
Interval 5316.88 to 21260.44
|
6695.75 Relative fluorescence units
Interval 837.0 to 10557.0
|
2331.25 Relative fluorescence units
Interval 830.5 to 10837.25
|
11340.75 Relative fluorescence units
Interval 5213.25 to 22000.0
|
15905.75 Relative fluorescence units
Interval 6229.75 to 21372.25
|
8418 Relative fluorescence units
Interval 2608.5 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_V3_peptide_biotin, 1: 50, M6.5
|
17530 Relative fluorescence units
Interval 8149.88 to 22000.0
|
22000 Relative fluorescence units
Interval 2471.0 to 22000.0
|
10530 Relative fluorescence units
Interval 4339.31 to 22000.0
|
13340.5 Relative fluorescence units
Interval 2089.19 to 22000.0
|
22000 Relative fluorescence units
Interval 14387.62 to 22000.0
|
22000 Relative fluorescence units
Interval 12141.19 to 22000.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MPER_peptide_biotin, 1: 50, M2.5
|
86 Relative fluorescence units
Interval 33.5 to 138.5
|
42.75 Relative fluorescence units
Interval 11.0 to 110.0
|
76.25 Relative fluorescence units
Interval 23.25 to 153.5
|
212.5 Relative fluorescence units
Interval 85.5 to 312.0
|
88.25 Relative fluorescence units
Interval 31.75 to 136.25
|
66.88 Relative fluorescence units
Interval 22.69 to 135.56
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MPER_peptide_biotin, 1: 50, M6.5
|
140.25 Relative fluorescence units
Interval 86.31 to 270.69
|
178.75 Relative fluorescence units
Interval 100.25 to 323.75
|
117.62 Relative fluorescence units
Interval 68.5 to 249.5
|
339.25 Relative fluorescence units
Interval 239.75 to 561.88
|
343.75 Relative fluorescence units
Interval 152.38 to 503.88
|
247.5 Relative fluorescence units
Interval 186.75 to 428.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MPER_peptide_biotin, 1: 50, M12
|
47.75 Relative fluorescence units
Interval 14.5 to 72.0
|
20.5 Relative fluorescence units
Interval 1.0 to 131.25
|
50.5 Relative fluorescence units
Interval 20.0 to 114.75
|
233.25 Relative fluorescence units
Interval 44.0 to 436.25
|
87.25 Relative fluorescence units
Interval 21.88 to 266.62
|
61 Relative fluorescence units
Interval 34.12 to 134.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BJOX002_D11gp120.avi/293F, 1: 50, M2.5
|
1 Relative fluorescence units
Interval 1.0 to 37.62
|
2 Relative fluorescence units
Interval 1.0 to 15.5
|
1 Relative fluorescence units
Interval 1.0 to 16.0
|
4.25 Relative fluorescence units
Interval 1.0 to 51.5
|
46.75 Relative fluorescence units
Interval 1.0 to 125.25
|
39.75 Relative fluorescence units
Interval 10.69 to 151.38
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BJOX002_D11gp120.avi/293F, 1: 50, M12
|
1 Relative fluorescence units
Interval 1.0 to 6.75
|
4.5 Relative fluorescence units
Interval 1.0 to 12.75
|
12.75 Relative fluorescence units
Interval 1.0 to 34.25
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
6 Relative fluorescence units
Interval 1.0 to 36.12
|
3.63 Relative fluorescence units
Interval 1.0 to 24.5
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BORI_D11gp120.avi/293F, 1: 50, M2.5
|
14.25 Relative fluorescence units
Interval 1.0 to 36.62
|
1 Relative fluorescence units
Interval 1.0 to 4.75
|
1 Relative fluorescence units
Interval 1.0 to 1.5
|
1 Relative fluorescence units
Interval 1.0 to 20.5
|
12.75 Relative fluorescence units
Interval 1.0 to 39.25
|
1 Relative fluorescence units
Interval 1.0 to 26.25
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BORI_D11gp120.avi/293F, 1: 50, M6.5
|
63.88 Relative fluorescence units
Interval 21.25 to 72.5
|
49.25 Relative fluorescence units
Interval 28.0 to 126.75
|
50.38 Relative fluorescence units
Interval 12.69 to 136.69
|
76.5 Relative fluorescence units
Interval 37.12 to 97.5
|
322.75 Relative fluorescence units
Interval 121.88 to 781.25
|
169.5 Relative fluorescence units
Interval 60.0 to 565.75
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BORI_D11gp120.avi/293F, 1: 50, M12
|
1 Relative fluorescence units
Interval 1.0 to 39.75
|
2.25 Relative fluorescence units
Interval 1.0 to 25.25
|
16.25 Relative fluorescence units
Interval 5.25 to 42.25
|
8.5 Relative fluorescence units
Interval 4.0 to 62.0
|
34.5 Relative fluorescence units
Interval 19.12 to 55.0
|
19.88 Relative fluorescence units
Interval 1.0 to 41.12
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
CNE20_D11gp120.avi/293F, 1: 50, M2.5
|
29.75 Relative fluorescence units
Interval 1.88 to 90.0
|
6.5 Relative fluorescence units
Interval 1.0 to 85.75
|
8.5 Relative fluorescence units
Interval 1.0 to 136.25
|
1 Relative fluorescence units
Interval 1.0 to 60.25
|
131.75 Relative fluorescence units
Interval 1.0 to 340.75
|
50 Relative fluorescence units
Interval 2.88 to 363.0
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
CNE20_D11gp120.avi/293F, 1: 50, M6.5
|
104.5 Relative fluorescence units
Interval 1.0 to 300.94
|
244.75 Relative fluorescence units
Interval 13.25 to 683.75
|
164.25 Relative fluorescence units
Interval 1.0 to 337.62
|
46.75 Relative fluorescence units
Interval 17.62 to 249.12
|
1164 Relative fluorescence units
Interval 447.62 to 1986.75
|
450 Relative fluorescence units
Interval 138.0 to 2473.5
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
CNE20_D11gp120.avi/293F, 1: 50, M12
|
1 Relative fluorescence units
Interval 1.0 to 1.0
|
1 Relative fluorescence units
Interval 1.0 to 7.0
|
8.25 Relative fluorescence units
Interval 1.0 to 41.25
|
1 Relative fluorescence units
Interval 1.0 to 46.0
|
43.5 Relative fluorescence units
Interval 1.88 to 129.25
|
1 Relative fluorescence units
Interval 1.0 to 77.81
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Link14_peptide_biotin, 1: 50, M2.5
|
1213 Relative fluorescence units
Interval 361.38 to 1924.0
|
179.25 Relative fluorescence units
Interval 55.75 to 450.75
|
165.25 Relative fluorescence units
Interval 33.25 to 365.5
|
1727.5 Relative fluorescence units
Interval 1115.5 to 3608.25
|
389.25 Relative fluorescence units
Interval 112.5 to 539.25
|
223.5 Relative fluorescence units
Interval 83.25 to 440.5
|
|
Magnitude of Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
254008_D11gp120.avi/293F, 1: 50, M6.5
|
133 Relative fluorescence units
Interval 10.38 to 489.25
|
418.5 Relative fluorescence units
Interval 41.25 to 1273.5
|
105.62 Relative fluorescence units
Interval 2.88 to 313.75
|
72.38 Relative fluorescence units
Interval 19.38 to 384.88
|
1636 Relative fluorescence units
Interval 592.0 to 2218.5
|
482.75 Relative fluorescence units
Interval 279.75 to 2414.75
|
SECONDARY outcome
Timeframe: 2 weeks after the 2nd vaccination (M2.5), 2 weeks after the 3rd vaccination (M6.5), 6 months after the 3rd vaccination (M12)Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 2nd vaccination, 2 weeks after the 3rd vaccination and 6 months after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available BAMA data after filtering for assay specific quality control criteria.
Serum HIV-1 specific IgG responses against BG505 MD39.3 trimer and BG505 MD39.3 CD4KO trimer were measured on a BioPlex instrument using a standardized custom HIV-1 Luminex assay. The readout was background subtracted mean fluorescence intensity (MFI), where background referred to a plate level control. Serum samples from post enrollment visits were declared to have positive direct binding responses if they met three conditions: 1) MFI\* ≥antigen specific positivity threshold (based on the 95th percentile of baseline samples and at least 100 MFI\*), 2) MFI\* \> 3x(Visit 2 MFI\* ), and 3) MFI \> 3x(Visit 2 MFI). MFI = Mean Fluorescent Intensity minus a plate specific background measure, MFI\* = MFI Blank, where 'Blank' is a sample specific background measure. Results from samples with high sample background (Blank\>5000 MFI), high baseline (Baseline\>6500 MFI\*) are excluded. MFI\* above 22,000 were truncated at 22,000, the upper limit of the linear range of the assay.
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M12
|
17 Participants
|
17 Participants
|
17 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_pHLsecAvi, 1: 50, M12
|
17 Participants
|
17 Participants
|
17 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_V3_peptide_biotin, 1: 50, M12
|
4 Participants
|
8 Participants
|
6 Participants
|
6 Participants
|
10 Participants
|
10 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BORI_D11gp120.avi/293F, 1: 50, M2.5
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Link14_peptide_biotin, 1: 50, M6.5
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
TT31P.2792_D11gp120.avi/293F, 1: 50, M6.5
|
5 Participants
|
10 Participants
|
8 Participants
|
3 Participants
|
12 Participants
|
15 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
scrambled_MD39_peptide-biotin, 1: 50, M6.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4, 1: 50, M12
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
15 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M2.5
|
14 Participants
|
15 Participants
|
16 Participants
|
10 Participants
|
17 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M6.5
|
16 Participants
|
16 Participants
|
16 Participants
|
10 Participants
|
15 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_baseKO_1CCv4, 1: 50, M12
|
16 Participants
|
16 Participants
|
15 Participants
|
11 Participants
|
15 Participants
|
15 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M2.5
|
15 Participants
|
16 Participants
|
17 Participants
|
12 Participants
|
17 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4_pHLsecAvi, 1: 50, M6.5
|
16 Participants
|
17 Participants
|
16 Participants
|
12 Participants
|
15 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_baseKO_1CCv4, 1: 50, M2.5
|
14 Participants
|
15 Participants
|
16 Participants
|
10 Participants
|
17 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_baseKO_1CCv4, 1: 50, M6.5
|
16 Participants
|
16 Participants
|
16 Participants
|
10 Participants
|
15 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_baseKO_1CCv4, 1: 50, M12
|
15 Participants
|
16 Participants
|
15 Participants
|
11 Participants
|
15 Participants
|
15 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_pHLsecAvi, 1: 50, M2.5
|
15 Participants
|
16 Participants
|
17 Participants
|
12 Participants
|
17 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_pHLsecAvi, 1: 50, M6.5
|
16 Participants
|
17 Participants
|
16 Participants
|
12 Participants
|
15 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_C1-113-125_biotin, 1: 50, M2.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_C1-113-125_biotin, 1: 50, M6.5
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_C1-113-125_biotin, 1: 50, M12
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-562-577_biotin, 1: 50, M2.5
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-562-577_biotin, 1: 50, M6.5
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-562-577_biotin, 1: 50, M12
|
0 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-572-587_biotin, 1: 50, M2.5
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-572-587_biotin, 1: 50, M6.5
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-572-587_biotin, 1: 50, M12
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M2.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M6.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_HR1-582-597_peptide_biotin, 1: 50, M12
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_V3_peptide_biotin, 1: 50, M2.5
|
11 Participants
|
8 Participants
|
7 Participants
|
10 Participants
|
14 Participants
|
11 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39_V3_peptide_biotin, 1: 50, M6.5
|
13 Participants
|
12 Participants
|
13 Participants
|
8 Participants
|
13 Participants
|
14 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MPER_peptide_biotin, 1: 50, M2.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MPER_peptide_biotin, 1: 50, M6.5
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MPER_peptide_biotin, 1: 50, M12
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BJOX002_D11gp120.avi/293F, 1: 50, M2.5
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
6 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BJOX002_D11gp120.avi/293F, 1: 50, M6.5
|
8 Participants
|
10 Participants
|
8 Participants
|
6 Participants
|
13 Participants
|
13 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BJOX002_D11gp120.avi/293F, 1: 50, M12
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BORI_D11gp120.avi/293F, 1: 50, M6.5
|
2 Participants
|
6 Participants
|
5 Participants
|
2 Participants
|
11 Participants
|
10 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BORI_D11gp120.avi/293F, 1: 50, M12
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
CNE20_D11gp120.avi/293F, 1: 50, M2.5
|
3 Participants
|
4 Participants
|
2 Participants
|
2 Participants
|
8 Participants
|
7 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
CNE20_D11gp120.avi/293F, 1: 50, M6.5
|
7 Participants
|
10 Participants
|
8 Participants
|
4 Participants
|
13 Participants
|
14 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
CNE20_D11gp120.avi/293F, 1: 50, M12
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
3 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Link14_peptide_biotin, 1: 50, M2.5
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
Link14_peptide_biotin, 1: 50, M12
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
TT31P.2792_D11gp120.avi/293F, 1: 50, M2.5
|
2 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
TT31P.2792_D11gp120.avi/293F, 1: 50, M12
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
gp41, 1: 50, M2.5
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
gp41, 1: 50, M6.5
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
gp41, 1: 50, M12
|
1 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
scrambled_MD39_peptide-biotin, 1: 50, M2.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
scrambled_MD39_peptide-biotin, 1: 50, M12
|
0 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
254008_D11gp120.avi/293F, 1: 50, M2.5
|
3 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
9 Participants
|
8 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
254008_D11gp120.avi/293F, 1: 50, M6.5
|
8 Participants
|
11 Participants
|
8 Participants
|
5 Participants
|
12 Participants
|
14 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
254008_D11gp120.avi/293F, 1: 50, M12
|
2 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
51802_D11gp120.avi/293F, 1: 50, M2.5
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
51802_D11gp120.avi/293F, 1: 50, M6.5
|
1 Participants
|
7 Participants
|
1 Participants
|
0 Participants
|
9 Participants
|
8 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
51802_D11gp120.avi/293F, 1: 50, M12
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
A244 D11gp120_avi, 1: 50, M2.5
|
4 Participants
|
5 Participants
|
3 Participants
|
4 Participants
|
7 Participants
|
8 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
A244 D11gp120_avi, 1: 50, M6.5
|
11 Participants
|
11 Participants
|
10 Participants
|
7 Participants
|
12 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
A244 D11gp120_avi, 1: 50, M12
|
3 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
3 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
B.6240_D11gp120/293F, 1: 50, M2.5
|
3 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
B.6240_D11gp120/293F, 1: 50, M6.5
|
5 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
11 Participants
|
12 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
B.6240_D11gp120/293F, 1: 50, M12
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3, 1: 50, M2.5
|
15 Participants
|
15 Participants
|
16 Participants
|
13 Participants
|
17 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3, 1: 50, M6.5
|
16 Participants
|
16 Participants
|
16 Participants
|
11 Participants
|
15 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3, 1: 50, M12
|
16 Participants
|
16 Participants
|
16 Participants
|
12 Participants
|
15 Participants
|
15 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4, 1: 50, M2.5
|
15 Participants
|
15 Participants
|
16 Participants
|
13 Participants
|
17 Participants
|
16 Participants
|
|
Response Rate Serum IgG Binding Antibodies to the BG505 Trimer, and Specific Epitopes (Base of Trimer, V3, Internal Epitope) as Measured by Binding Antibody Multiplex Assay (BAMA)
BG505_MD39.3_CD4KO4, 1: 50, M6.5
|
16 Participants
|
16 Participants
|
16 Participants
|
11 Participants
|
15 Participants
|
16 Participants
|
SECONDARY outcome
Timeframe: 2 weeks after the 3rd vaccination (M6.5)Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5
|
0.2 Percent T-cells expressing cytokines
Interval 0.1 to 0.2
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.2 Percent T-cells expressing cytokines
Interval 0.2 to 0.3
|
0.1 Percent T-cells expressing cytokines
Interval 0.1 to 0.3
|
0.1 Percent T-cells expressing cytokines
Interval 0.1 to 0.2
|
0.1 Percent T-cells expressing cytokines
Interval 0.1 to 0.2
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5
|
0.2 Percent T-cells expressing cytokines
Interval 0.1 to 0.3
|
0.2 Percent T-cells expressing cytokines
Interval 0.2 to 0.3
|
0.2 Percent T-cells expressing cytokines
Interval 0.2 to 0.5
|
0.1 Percent T-cells expressing cytokines
Interval 0.1 to 0.3
|
0.3 Percent T-cells expressing cytokines
Interval 0.3 to 0.4
|
0.3 Percent T-cells expressing cytokines
Interval 0.1 to 0.6
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp120, IL-21, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.2
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.1 to 0.2
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp41, IL-21, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505-MD39.3 gp140 protein, IL-21, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
LeadSeq mRNA, IFN-γ and/or IL-2, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
LeadSeq mRNA, IL-21, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Total Env, IFN-γ and/or IL-2, M6.5
|
0.2 Percent T-cells expressing cytokines
Interval 0.1 to 0.4
|
0.3 Percent T-cells expressing cytokines
Interval 0.2 to 0.4
|
0.3 Percent T-cells expressing cytokines
Interval 0.2 to 0.6
|
0.2 Percent T-cells expressing cytokines
Interval 0.1 to 0.4
|
0.4 Percent T-cells expressing cytokines
Interval 0.3 to 0.5
|
0.5 Percent T-cells expressing cytokines
Interval 0.2 to 0.7
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Total Env, IL-21, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.1 to 0.1
|
0.1 Percent T-cells expressing cytokines
Interval 0.1 to 0.2
|
|
Magnitude of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.0
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
0 Percent T-cells expressing cytokines
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: 2 weeks after the 3rd vaccination (M6.5)Population: In this report, the overall number of participants analyzed represents the enrolled participants at 2 weeks after the 3rd vaccination. The Number Analyzed in the Outcome Measure Data Table shows the number of participants with available ICS data after filtering for assay specific quality control criteria.
Flow cytometry was used to examine HIV-1-specific CD4+ T-cell responses using a validated the 27-color COVID v2 staining panel. Response magnitudes were defined as the negative control- or background adjusted percent of CD4+ T cells expressing the cytokines or cytokine combinations. Total Env is the sum of gp120 and gp41 peptide pools. One-sided Fisher's exact test was applied to test whether the number of cytokine-producing cells for the stimulated data was equal to that for the negative control data. A multiplicity adjustment was made to the individual peptide pool p-values using the Bonferroni-Holm adjustment method. If the adjusted p-value for a peptide pool was ≤ 0.00001, the response to the peptide pool for the T-cell subset was considered positive. Records are excluded if the number of CD4+ T-cell subsets is less than ten thousands
Outcome measures
| Measure |
Part A, Group 1: Treatment
n=18 Participants
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 Participants
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 Participants
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 Participants
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp41, IL-21, M6.5
|
3 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
9 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
LeadSeq mRNA, IL-21, M6.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
LeadSeq mRNA, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Total Env, IFN-γ and/or IL-2, M6.5
|
12 Participants
|
16 Participants
|
14 Participants
|
10 Participants
|
14 Participants
|
16 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Total Env, IL-21, M6.5
|
10 Participants
|
12 Participants
|
10 Participants
|
7 Participants
|
11 Participants
|
14 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
Total Env, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
6 Participants
|
11 Participants
|
9 Participants
|
5 Participants
|
10 Participants
|
10 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp120, IFN-γ and/or IL-2, M6.5
|
12 Participants
|
16 Participants
|
14 Participants
|
10 Participants
|
14 Participants
|
16 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp120, IL-21, M6.5
|
10 Participants
|
12 Participants
|
10 Participants
|
6 Participants
|
11 Participants
|
14 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp120, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
6 Participants
|
11 Participants
|
9 Participants
|
5 Participants
|
10 Participants
|
10 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp41, IFN-γ and/or IL-2, M6.5
|
11 Participants
|
14 Participants
|
13 Participants
|
5 Participants
|
12 Participants
|
14 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505 MD39.3 gp41, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
1 Participants
|
7 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505-MD39.3 gp140 protein, IFN-γ and/or IL-2, M6.5
|
4 Participants
|
5 Participants
|
4 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505-MD39.3 gp140 protein, IL-21, M6.5
|
4 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
BG505-MD39.3 gp140 protein, IL-4 or IL-5 or IL-13 and CD154, M6.5
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
4 Participants
|
|
Response Rate of CD4+ T-cell Responses as Assessed by Intracellular Cytokine Staining Assays (ICS)
LeadSeq mRNA, IFN-γ and/or IL-2, M6.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
Adverse Events
Part A, Group 1: Treatment
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Part A, Group 2: Treatment
Serious events: 1 serious events
Other events: 19 other events
Deaths: 0 deaths
Part A, Group 3: Treatment
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
Part B, Group 4: Treatment
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part B, Group 5: Treatment
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Part B, Group 6: Treatment
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A, Group 1: Treatment
n=18 participants at risk
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 participants at risk
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 participants at risk
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 participants at risk
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 participants at risk
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 participants at risk
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
Other adverse events
| Measure |
Part A, Group 1: Treatment
n=18 participants at risk
100 mcg of BG505 MD39.3 mRNA
|
Part A, Group 2: Treatment
n=19 participants at risk
100 mcg of BG505 MD39.3 gp151 mRNA
|
Part A, Group 3: Treatment
n=17 participants at risk
100 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
Part B, Group 4: Treatment
n=18 participants at risk
250 mcg of BG505 MD39.3 mRNA
|
Part B, Group 5: Treatment
n=18 participants at risk
250 mcg of BG505 MD39.3 gp151 mRNA
|
Part B, Group 6: Treatment
n=18 participants at risk
250 mcg of BG505 MD39.3 gp151 CD4KO mRNA
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Anaemia
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
11.1%
2/18 • Number of events 3 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
11.1%
2/18 • Number of events 4 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Cardiac disorders
Arrhythmia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Cardiac disorders
Palpitations
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Ear and labyrinth disorders
Ear pain
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Ear and labyrinth disorders
Inner ear inflammation
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Abdominal discomfort
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Diverticulum intestinal
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Dry mouth
|
5.6%
1/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Nausea (Solicited)
|
22.2%
4/18 • Number of events 7 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
15.8%
3/19 • Number of events 6 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
47.1%
8/17 • Number of events 13 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
38.9%
7/18 • Number of events 10 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
50.0%
9/18 • Number of events 14 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
55.6%
10/18 • Number of events 16 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Axillary pain
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Chest discomfort
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Chills (Solicited)
|
61.1%
11/18 • Number of events 16 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
31.6%
6/19 • Number of events 11 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
64.7%
11/17 • Number of events 17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
38.9%
7/18 • Number of events 9 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
88.9%
16/18 • Number of events 23 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
72.2%
13/18 • Number of events 17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Fatigue
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Fatigue (Solicited)
|
88.9%
16/18 • Number of events 34 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
63.2%
12/19 • Number of events 26 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
88.2%
15/17 • Number of events 38 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
83.3%
15/18 • Number of events 29 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
100.0%
18/18 • Number of events 40 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
83.3%
15/18 • Number of events 31 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Injection site erythema (Solicited)
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
31.6%
6/19 • Number of events 10 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
11.1%
2/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
16.7%
3/18 • Number of events 3 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
33.3%
6/18 • Number of events 8 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Injection site pain (Solicited)
|
100.0%
18/18 • Number of events 49 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
94.7%
18/19 • Number of events 47 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
94.1%
16/17 • Number of events 46 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
100.0%
18/18 • Number of events 37 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
100.0%
18/18 • Number of events 49 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
100.0%
18/18 • Number of events 49 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Injection site pruritus
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Injection site swelling (Solicited)
|
11.1%
2/18 • Number of events 3 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
21.1%
4/19 • Number of events 5 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
29.4%
5/17 • Number of events 9 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
22.2%
4/18 • Number of events 4 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 3 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
22.2%
4/18 • Number of events 6 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Injury associated with device
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Nodule
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Non-cardiac chest pain
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Pyrexia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
General disorders
Swelling
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Immune system disorders
Hypersensitivity
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Anal chlamydia infection
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
COVID-19
|
38.9%
7/18 • Number of events 7 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
21.1%
4/19 • Number of events 4 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
11.8%
2/17 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
16.7%
3/18 • Number of events 3 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
33.3%
6/18 • Number of events 6 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Gastroenteritis Escherichia coli
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Hordeolum
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Influenza
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Postoperative wound infection
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Skin candida
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Spirochaetal infection
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Syphilis
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Upper respiratory tract infection
|
11.1%
2/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Viral infection
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Injury, poisoning and procedural complications
Exposure to communicable disease
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Injury, poisoning and procedural complications
Overdose
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Injury, poisoning and procedural complications
Skin laceration
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Injury, poisoning and procedural complications
Soft tissue injury
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Investigations
Alanine aminotransferase increased
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Investigations
Aspartate aminotransferase increased
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
10.5%
2/19 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Investigations
Blood pressure increased
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
10.5%
2/19 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
11.1%
2/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Investigations
Body temperature increased (Solicited)
|
22.2%
4/18 • Number of events 4 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
31.6%
6/19 • Number of events 8 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
33.3%
6/18 • Number of events 8 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
50.0%
9/18 • Number of events 13 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Investigations
Creatinine renal clearance decreased
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Investigations
Haemoglobin decreased
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
11.8%
2/17 • Number of events 3 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Investigations
Neutrophil count decreased
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Metabolism and nutrition disorders
Hyperglycaemia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
11.1%
2/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (Solicited)
|
44.4%
8/18 • Number of events 13 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
47.4%
9/19 • Number of events 12 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
70.6%
12/17 • Number of events 18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
38.9%
7/18 • Number of events 10 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
55.6%
10/18 • Number of events 13 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
61.1%
11/18 • Number of events 16 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Musculoskeletal and connective tissue disorders
Myalgia (Solicited)
|
72.2%
13/18 • Number of events 22 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
42.1%
8/19 • Number of events 15 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
70.6%
12/17 • Number of events 23 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
61.1%
11/18 • Number of events 18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
100.0%
18/18 • Number of events 34 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
100.0%
18/18 • Number of events 31 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
10.5%
2/19 • Number of events 4 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Nervous system disorders
Dizziness
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
17.6%
3/17 • Number of events 3 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Nervous system disorders
Headache
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Nervous system disorders
Headache (Solicited)
|
77.8%
14/18 • Number of events 21 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
68.4%
13/19 • Number of events 27 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
82.4%
14/17 • Number of events 29 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
83.3%
15/18 • Number of events 26 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
94.4%
17/18 • Number of events 33 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
94.4%
17/18 • Number of events 32 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Nervous system disorders
Hypoaesthesia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Nervous system disorders
Presyncope
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Nervous system disorders
Seizure
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Nervous system disorders
Syncope
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Psychiatric disorders
Anxiety
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Psychiatric disorders
Attention deficit hyperactivity disorder
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Psychiatric disorders
Depression
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Psychiatric disorders
Substance use disorder
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Psychiatric disorders
Suicidal ideation
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Reproductive system and breast disorders
Uterine malposition
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma exercise induced
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Bronchial irritation
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea exertional
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Obstructive sleep apnoea syndrome
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory symptom
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Respiratory, thoracic and mediastinal disorders
Tonsillar hypertrophy
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Acne
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Angioedema
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.6%
1/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
16.7%
3/18 • Number of events 3 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.3%
1/19 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
5.9%
1/17 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
11.1%
2/18 • Number of events 2 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
|
Vascular disorders
Hypertension
|
5.6%
1/18 • Number of events 1 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/19 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/17 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
0.00%
0/18 • Unsolicited AEs were collected over a period of 30 days after each vaccination. The Solicited AE assessment were collected through 7 full days after each vaccination. A limited set of AEs, including SAEs, were collected and reported through the end of the main study (Month 12).
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place