Trial Outcomes & Findings for Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults (NCT NCT03409276)
NCT ID: NCT03409276
Last Updated: 2022-04-25
Results Overview
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. The maximum grade observed for each symptom over the time frame is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
60 participants
Primary outcome timeframe
Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part B
Results posted on
2022-04-25
Participant Flow
Participant milestones
| Measure |
Part A: Placebo
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
2
|
10
|
6
|
21
|
21
|
|
Overall Study
Month 2.5 Immunogenicity Cohort
|
2
|
10
|
0
|
0
|
0
|
|
Overall Study
Month 8.5 Immunogenicity Cohort
|
0
|
0
|
6
|
19
|
16
|
|
Overall Study
COMPLETED
|
2
|
10
|
6
|
19
|
18
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
2
|
3
|
Reasons for withdrawal
| Measure |
Part A: Placebo
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
2
|
2
|
Baseline Characteristics
Evaluating the Safety and Immunogenicity of Env (A,B,C,A/E)/Gag (C) DNA and gp120 (A,B,C,A/E) Protein/GLA-SE HIV Vaccines, Given Individually or Co-administered, in Healthy, HIV-1-Uninfected Adults
Baseline characteristics by cohort
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
36.5 years
n=5 Participants
|
22.5 years
n=7 Participants
|
29 years
n=5 Participants
|
25 years
n=4 Participants
|
31 years
n=21 Participants
|
26.5 years
n=8 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
18 - 20 years
|
0 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
7 Participants
n=8 Participants
|
|
Age, Customized
21 - 30 years
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
12 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
30 Participants
n=8 Participants
|
|
Age, Customized
31 - 40 years
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
9 Participants
n=21 Participants
|
18 Participants
n=8 Participants
|
|
Age, Customized
41 - 50 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
13 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
34 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
1 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
26 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
20 Participants
n=4 Participants
|
20 Participants
n=21 Participants
|
58 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
6 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
1 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
14 Participants
n=4 Participants
|
17 Participants
n=21 Participants
|
43 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
|
Region of Enrollment
USA
|
2 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
21 Participants
n=21 Participants
|
60 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part BGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
5 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · None
|
2 Participants
|
5 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Mild
|
0 Participants
|
4 Participants
|
1 Participants
|
12 Participants
|
15 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · None
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Mild
|
0 Participants
|
6 Participants
|
2 Participants
|
15 Participants
|
17 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · None
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Mild
|
0 Participants
|
6 Participants
|
2 Participants
|
13 Participants
|
15 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · None
|
2 Participants
|
10 Participants
|
6 Participants
|
14 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · None
|
2 Participants
|
10 Participants
|
6 Participants
|
16 Participants
|
14 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · None
|
2 Participants
|
10 Participants
|
6 Participants
|
14 Participants
|
12 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after participants' each vaccination at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part BGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
1 Participants
|
8 Participants
|
4 Participants
|
12 Participants
|
15 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
1 Participants
|
5 Participants
|
2 Participants
|
4 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
1 Participants
|
5 Participants
|
1 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
7 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
1 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
1 Participants
|
6 Participants
|
4 Participants
|
8 Participants
|
11 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
1 Participants
|
4 Participants
|
2 Participants
|
9 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
1 Participants
|
5 Participants
|
2 Participants
|
3 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
1 Participants
|
5 Participants
|
3 Participants
|
10 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
6 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
2 Participants
|
10 Participants
|
6 Participants
|
17 Participants
|
18 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
2 Participants
|
10 Participants
|
6 Participants
|
11 Participants
|
15 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
2 Participants
|
8 Participants
|
6 Participants
|
10 Participants
|
17 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
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
|
3 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
1 Participants
|
6 Participants
|
0 Participants
|
8 Participants
|
8 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
0 Participants
|
1 Participants
|
3 Participants
|
8 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
2 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
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
2 Participants
|
10 Participants
|
6 Participants
|
15 Participants
|
16 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part BFor participants reporting multiple AEs over the time frame, the maximum relationship is counted.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Related
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
Not Related
|
2 Participants
|
6 Participants
|
5 Participants
|
14 Participants
|
16 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Relationship to Study Product
No AE reported
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Measured through 30 days after each vaccine dose at Months 0, 2 for part A and Months 0, 1, 3, 6, 8 for part BFor participants reporting multiple AEs over the time frame, the maximum severity grade is counted.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Moderate
|
2 Participants
|
4 Participants
|
4 Participants
|
18 Participants
|
14 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Adverse Events (AEs), by Severity Grade
No AE reported
|
0 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 8 for part A and Month 14 for part BMeasured as outlined in Version 2.0 (January 2010) of the Manual for Expedited Reporting of Adverse Events to DAIDS (DAIDS EAE Manual).
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 8 for part A and Month 14 for part BAdverse events of special interest were described in Appendix N of the protocol. AESI for this protocol include but are not limited to potential immune-mediated diseases. There were no adverse events of special interest reported by any participant.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events of Special Interest (AESIs)
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured during Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part BPopulation: The "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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with local laboratory values recorded as meeting Grade 1 AE criteria or above as specified in the DAIDS AE Grading Table were tabulated by treatment arm for each post-vaccination time point. Laboratory results are summarized by analyte and timepoint. Analytes and timepoint combinations with no grade 1 or higher results are not shown.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
AST (U/L)- Day42
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
AST (U/L)- Day98
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
AST (U/L)- Day140
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
ALT (SGPT) (U/L)- Day42
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day182
|
—
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day238
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Hemoglobin (g/dL)- Day334
|
—
|
—
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day14
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day42
|
—
|
—
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day98
|
—
|
—
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day182
|
—
|
—
|
0 Participants
|
2 Participants
|
2 Participants
|
|
Numbers of Participants With Grade 1 or Higher Local Laboratory Results
Creatinine (g/dL)- Day334
|
—
|
—
|
1 Participants
|
0 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part BPopulation: The "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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Screening
|
22 U/L
Interval 21.0 to 23.0
|
14.5 U/L
Interval 11.0 to 21.0
|
22.5 U/L
Interval 16.0 to 25.0
|
13 U/L
Interval 10.0 to 18.0
|
16 U/L
Interval 13.0 to 24.0
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Screening
|
61 U/L
Interval 58.0 to 64.0
|
59.5 U/L
Interval 46.0 to 69.0
|
54.5 U/L
Interval 51.0 to 60.0
|
61 U/L
Interval 56.0 to 74.0
|
59 U/L
Interval 52.0 to 78.0
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Day14
|
57.5 U/L
Interval 46.0 to 69.0
|
56 U/L
Interval 43.0 to 81.0
|
53 U/L
Interval 49.0 to 56.0
|
62 U/L
Interval 56.0 to 71.0
|
60 U/L
Interval 51.0 to 65.5
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Day42
|
—
|
—
|
56 U/L
Interval 53.0 to 59.0
|
69 U/L
Interval 58.0 to 73.0
|
57 U/L
Interval 51.0 to 68.0
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Day70
|
54 U/L
Interval 51.0 to 57.0
|
55 U/L
Interval 50.0 to 76.0
|
—
|
—
|
—
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Day98
|
—
|
—
|
54 U/L
Interval 51.0 to 57.0
|
64 U/L
Interval 54.0 to 77.0
|
61 U/L
Interval 50.0 to 72.0
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Day140
|
57.5 U/L
Interval 50.0 to 65.0
|
59 U/L
Interval 50.0 to 68.0
|
—
|
—
|
—
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Day182
|
—
|
—
|
59.5 U/L
Interval 52.0 to 61.0
|
63 U/L
Interval 56.0 to 72.0
|
60.5 U/L
Interval 44.0 to 68.0
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Day238
|
—
|
—
|
52 U/L
Interval 50.0 to 73.0
|
61.5 U/L
Interval 52.0 to 72.0
|
58.5 U/L
Interval 49.0 to 69.0
|
|
Alk Phos, AST, ALT in UL
Alkaline Phosphatase (U/L)- Day334
|
—
|
—
|
52.5 U/L
Interval 50.0 to 67.0
|
62.5 U/L
Interval 52.0 to 66.0
|
62 U/L
Interval 50.0 to 67.5
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Screening
|
18 U/L
Interval 16.0 to 20.0
|
19 U/L
Interval 16.0 to 19.0
|
16.5 U/L
Interval 15.0 to 27.0
|
16 U/L
Interval 14.0 to 19.0
|
19 U/L
Interval 18.0 to 23.0
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Day14
|
19 U/L
Interval 16.0 to 22.0
|
15 U/L
Interval 14.0 to 19.0
|
19.5 U/L
Interval 18.0 to 25.0
|
17 U/L
Interval 14.0 to 20.0
|
19 U/L
Interval 16.0 to 20.0
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Day42
|
—
|
—
|
17 U/L
Interval 13.0 to 20.0
|
15 U/L
Interval 15.0 to 21.0
|
17 U/L
Interval 16.0 to 20.0
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Day70
|
13 U/L
Interval 12.0 to 14.0
|
17 U/L
Interval 15.0 to 19.0
|
—
|
—
|
—
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Day98
|
—
|
—
|
16 U/L
Interval 16.0 to 20.0
|
17 U/L
Interval 14.0 to 20.0
|
18 U/L
Interval 16.0 to 21.0
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Day140
|
13.5 U/L
Interval 12.0 to 15.0
|
17 U/L
Interval 15.0 to 26.0
|
—
|
—
|
—
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Day182
|
—
|
—
|
14.5 U/L
Interval 12.0 to 16.0
|
16 U/L
Interval 15.0 to 18.0
|
17.5 U/L
Interval 16.0 to 18.0
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Day238
|
—
|
—
|
15.5 U/L
Interval 13.0 to 18.0
|
16 U/L
Interval 14.0 to 18.0
|
16 U/L
Interval 15.5 to 22.0
|
|
Alk Phos, AST, ALT in UL
AST (U/L)- Day334
|
—
|
—
|
15.5 U/L
Interval 14.0 to 24.0
|
16 U/L
Interval 14.0 to 18.0
|
19 U/L
Interval 15.5 to 21.0
|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Day14
|
21.5 U/L
Interval 19.0 to 24.0
|
10 U/L
Interval 8.0 to 19.0
|
19.5 U/L
Interval 16.0 to 30.0
|
14 U/L
Interval 12.0 to 18.0
|
15 U/L
Interval 12.5 to 20.5
|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Day42
|
—
|
—
|
17 U/L
Interval 12.0 to 20.0
|
14 U/L
Interval 11.0 to 16.0
|
15 U/L
Interval 11.0 to 22.0
|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Day70
|
18 U/L
Interval 11.0 to 25.0
|
14.5 U/L
Interval 10.0 to 19.0
|
—
|
—
|
—
|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Day98
|
—
|
—
|
15 U/L
Interval 15.0 to 16.0
|
14 U/L
Interval 11.0 to 17.0
|
15 U/L
Interval 10.0 to 19.0
|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Day140
|
21 U/L
Interval 11.0 to 31.0
|
14.5 U/L
Interval 12.0 to 20.0
|
—
|
—
|
—
|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Day182
|
—
|
—
|
12.5 U/L
Interval 10.0 to 19.0
|
12 U/L
Interval 10.0 to 15.0
|
15.5 U/L
Interval 14.0 to 19.0
|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Day238
|
—
|
—
|
15.5 U/L
Interval 11.0 to 19.0
|
11.5 U/L
Interval 11.0 to 15.0
|
12.5 U/L
Interval 9.0 to 22.0
|
|
Alk Phos, AST, ALT in UL
ALT (SGPT) (U/L)- Day334
|
—
|
—
|
17 U/L
Interval 12.0 to 20.0
|
13 U/L
Interval 10.0 to 15.0
|
15.5 U/L
Interval 12.0 to 26.5
|
PRIMARY outcome
Timeframe: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part BPopulation: The "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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Screening
|
14.7 g/dL
Interval 13.7 to 15.7
|
13.75 g/dL
Interval 12.7 to 15.2
|
13.85 g/dL
Interval 13.2 to 14.6
|
14.7 g/dL
Interval 13.2 to 15.0
|
14.8 g/dL
Interval 13.4 to 15.4
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day14
|
14.65 g/dL
Interval 14.4 to 14.9
|
13.45 g/dL
Interval 12.8 to 14.3
|
13.5 g/dL
Interval 12.3 to 14.4
|
13.5 g/dL
Interval 12.5 to 14.8
|
13.95 g/dL
Interval 12.75 to 14.7
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day42
|
—
|
—
|
13.9 g/dL
Interval 12.5 to 14.4
|
13.8 g/dL
Interval 13.1 to 14.5
|
13.8 g/dL
Interval 13.3 to 15.1
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day70
|
13.25 g/dL
Interval 12.5 to 14.0
|
14.1 g/dL
Interval 13.0 to 14.5
|
—
|
—
|
—
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day98
|
—
|
—
|
13.2 g/dL
Interval 12.7 to 14.6
|
14 g/dL
Interval 12.9 to 14.7
|
14.8 g/dL
Interval 13.4 to 15.3
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day140
|
14.35 g/dL
Interval 13.0 to 15.7
|
13.65 g/dL
Interval 12.3 to 14.6
|
—
|
—
|
—
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day182
|
—
|
—
|
13.6 g/dL
Interval 12.2 to 14.0
|
13.4 g/dL
Interval 11.6 to 14.2
|
14 g/dL
Interval 13.2 to 14.8
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day238
|
—
|
—
|
13.5 g/dL
Interval 11.2 to 14.4
|
13.2 g/dL
Interval 12.2 to 14.0
|
14 g/dL
Interval 12.8 to 15.1
|
|
Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day334
|
—
|
—
|
14.25 g/dL
Interval 11.4 to 14.6
|
12.75 g/dL
Interval 12.1 to 14.3
|
14.15 g/dL
Interval 13.25 to 14.85
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Screening
|
0.00094 g/dL
Interval 0.00079 to 0.00109
|
0.00077 g/dL
Interval 0.00068 to 0.00093
|
0.000795 g/dL
Interval 0.00074 to 0.00091
|
0.00078 g/dL
Interval 0.00068 to 0.00083
|
0.0008 g/dL
Interval 0.00075 to 0.0009
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day14
|
0.00102 g/dL
Interval 0.0008 to 0.00124
|
0.000815 g/dL
Interval 0.00079 to 0.00092
|
0.000835 g/dL
Interval 0.00077 to 0.00093
|
0.00075 g/dL
Interval 0.00071 to 0.00085
|
0.000835 g/dL
Interval 0.00075 to 0.00091
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day42
|
—
|
—
|
0.00081 g/dL
Interval 0.00071 to 0.00099
|
0.00079 g/dL
Interval 0.00071 to 0.00083
|
0.00087 g/dL
Interval 0.00073 to 0.00094
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day70
|
0.00088 g/dL
Interval 0.00072 to 0.00104
|
0.00075 g/dL
Interval 0.0007 to 0.00096
|
—
|
—
|
—
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day98
|
—
|
—
|
0.00083 g/dL
Interval 0.00075 to 0.0009
|
0.0008 g/dL
Interval 0.0007 to 0.00086
|
0.00084 g/dL
Interval 0.00075 to 0.001
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day140
|
0.000935 g/dL
Interval 0.00086 to 0.00101
|
0.000765 g/dL
Interval 0.00069 to 0.00095
|
—
|
—
|
—
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day182
|
—
|
—
|
0.00085 g/dL
Interval 0.00072 to 0.00092
|
0.00088 g/dL
Interval 0.00078 to 0.00094
|
0.000855 g/dL
Interval 0.0008 to 0.00105
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day238
|
—
|
—
|
0.000815 g/dL
Interval 0.00076 to 0.00087
|
0.00076 g/dL
Interval 0.0007 to 0.00082
|
0.000845 g/dL
Interval 0.00076 to 0.00092
|
|
Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day334
|
—
|
—
|
0.00082 g/dL
Interval 0.00076 to 0.00104
|
0.00081 g/dL
Interval 0.0007 to 0.00088
|
0.000895 g/dL
Interval 0.0008 to 0.00097
|
PRIMARY outcome
Timeframe: Measured through Screening, Day 14, Day 70, Day140 for part A and visits Screening, Day 14, Day 42, Day 98, Day 182, Day 238 and Day 334 for part BPopulation: The "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, or they missed the scheduled visit, or they terminated participation in the study prior to the scheduled visit.
Laboratory results are summarized by analyte and timepoint.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day238
|
—
|
—
|
3.349 thousand cells/cubic mm
Interval 2.832 to 3.886
|
3.413 thousand cells/cubic mm
Interval 2.57 to 4.074
|
3.9935 thousand cells/cubic mm
Interval 3.1115 to 4.3735
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day42
|
—
|
—
|
3.7595 thousand cells/cubic mm
Interval 3.375 to 6.01
|
3.66 thousand cells/cubic mm
Interval 2.885 to 4.509
|
3.317 thousand cells/cubic mm
Interval 2.945 to 3.95
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day70
|
3.072 thousand cells/cubic mm
Interval 1.904 to 4.24
|
3.9035 thousand cells/cubic mm
Interval 3.161 to 4.417
|
—
|
—
|
—
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day98
|
—
|
—
|
3.492 thousand cells/cubic mm
Interval 3.27 to 3.578
|
3.67 thousand cells/cubic mm
Interval 2.749 to 4.303
|
3.101 thousand cells/cubic mm
Interval 2.235 to 4.541
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day140
|
2.01 thousand cells/cubic mm
Interval 1.681 to 2.339
|
3.7175 thousand cells/cubic mm
Interval 3.034 to 4.869
|
—
|
—
|
—
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day182
|
—
|
—
|
3.821 thousand cells/cubic mm
Interval 3.278 to 4.284
|
3.264 thousand cells/cubic mm
Interval 2.301 to 4.09
|
3.684 thousand cells/cubic mm
Interval 2.86 to 4.14
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day334
|
—
|
—
|
3.3185 thousand cells/cubic mm
Interval 2.85 to 3.559
|
3.135 thousand cells/cubic mm
Interval 2.41 to 4.235
|
3.395 thousand cells/cubic mm
Interval 2.7725 to 4.2395
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Screening
|
5.1 thousand cells/cubic mm
Interval 4.4 to 5.8
|
6.305 thousand cells/cubic mm
Interval 4.8 to 7.3
|
5.9 thousand cells/cubic mm
Interval 5.3 to 6.2
|
5.7 thousand cells/cubic mm
Interval 5.2 to 7.1
|
6.4 thousand cells/cubic mm
Interval 5.5 to 7.4
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day14
|
4.35 thousand cells/cubic mm
Interval 3.4 to 5.3
|
5.62 thousand cells/cubic mm
Interval 4.4 to 7.5
|
5.65 thousand cells/cubic mm
Interval 4.8 to 6.6
|
6 thousand cells/cubic mm
Interval 5.6 to 6.8
|
6.4 thousand cells/cubic mm
Interval 5.185 to 6.85
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day42
|
—
|
—
|
6.45 thousand cells/cubic mm
Interval 5.4 to 8.3
|
6.2 thousand cells/cubic mm
Interval 5.1 to 7.1
|
6.3 thousand cells/cubic mm
Interval 5.3 to 6.9
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day70
|
5.8 thousand cells/cubic mm
Interval 3.6 to 8.0
|
6.12 thousand cells/cubic mm
Interval 5.6 to 7.3
|
—
|
—
|
—
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day98
|
—
|
—
|
5.8 thousand cells/cubic mm
Interval 5.6 to 6.0
|
6.11 thousand cells/cubic mm
Interval 5.3 to 7.1
|
5.7 thousand cells/cubic mm
Interval 4.8 to 6.7
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day140
|
4.15 thousand cells/cubic mm
Interval 4.1 to 4.2
|
6.26 thousand cells/cubic mm
Interval 4.9 to 9.1
|
—
|
—
|
—
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day182
|
—
|
—
|
6 thousand cells/cubic mm
Interval 5.4 to 6.6
|
5.6 thousand cells/cubic mm
Interval 5.1 to 7.1
|
6.25 thousand cells/cubic mm
Interval 5.0 to 7.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day238
|
—
|
—
|
6 thousand cells/cubic mm
Interval 4.8 to 6.2
|
6 thousand cells/cubic mm
Interval 5.0 to 7.0
|
6.15 thousand cells/cubic mm
Interval 5.57 to 6.75
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
WBC (1000/cubic mm)- Day334
|
—
|
—
|
5.4 thousand cells/cubic mm
Interval 5.0 to 6.2
|
5.6 thousand cells/cubic mm
Interval 5.01 to 6.7
|
5.88 thousand cells/cubic mm
Interval 5.25 to 6.65
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Screening
|
288 thousand cells/cubic mm
Interval 236.0 to 340.0
|
296 thousand cells/cubic mm
Interval 266.9 to 341.0
|
229 thousand cells/cubic mm
Interval 217.0 to 387.0
|
250 thousand cells/cubic mm
Interval 212.0 to 295.0
|
246 thousand cells/cubic mm
Interval 210.0 to 273.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day14
|
297 thousand cells/cubic mm
Interval 205.0 to 389.0
|
297.5 thousand cells/cubic mm
Interval 259.0 to 323.0
|
236 thousand cells/cubic mm
Interval 210.0 to 328.0
|
244 thousand cells/cubic mm
Interval 205.0 to 277.0
|
226.5 thousand cells/cubic mm
Interval 201.55 to 278.5
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day42
|
—
|
—
|
238 thousand cells/cubic mm
Interval 207.0 to 334.0
|
243 thousand cells/cubic mm
Interval 209.0 to 313.0
|
260.5 thousand cells/cubic mm
Interval 193.0 to 291.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day70
|
277.5 thousand cells/cubic mm
Interval 243.0 to 312.0
|
286 thousand cells/cubic mm
Interval 266.0 to 308.0
|
—
|
—
|
—
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day98
|
—
|
—
|
223 thousand cells/cubic mm
Interval 203.0 to 256.0
|
244 thousand cells/cubic mm
Interval 193.0 to 311.0
|
224 thousand cells/cubic mm
Interval 191.1 to 268.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day140
|
264.5 thousand cells/cubic mm
Interval 243.0 to 286.0
|
287 thousand cells/cubic mm
Interval 274.0 to 304.0
|
—
|
—
|
—
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day182
|
—
|
—
|
215.5 thousand cells/cubic mm
Interval 205.0 to 328.0
|
278 thousand cells/cubic mm
Interval 201.0 to 362.6
|
232 thousand cells/cubic mm
Interval 190.0 to 287.0
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day238
|
—
|
—
|
234.5 thousand cells/cubic mm
Interval 210.0 to 315.0
|
266.1 thousand cells/cubic mm
Interval 229.0 to 336.0
|
239.8 thousand cells/cubic mm
Interval 188.0 to 287.9
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Platelets (1000/cubic mm)- Day334
|
—
|
—
|
253.5 thousand cells/cubic mm
Interval 197.0 to 339.0
|
280 thousand cells/cubic mm
Interval 218.0 to 347.0
|
239.05 thousand cells/cubic mm
Interval 192.0 to 273.5
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Screening
|
2.189 thousand cells/cubic mm
Interval 1.148 to 3.23
|
1.942 thousand cells/cubic mm
Interval 1.579 to 2.403
|
1.7635 thousand cells/cubic mm
Interval 1.63 to 1.911
|
1.918 thousand cells/cubic mm
Interval 1.664 to 2.213
|
2.134 thousand cells/cubic mm
Interval 1.863 to 2.28
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day14
|
2.037 thousand cells/cubic mm
Interval 1.054 to 3.02
|
1.7895 thousand cells/cubic mm
Interval 1.452 to 2.001
|
1.8115 thousand cells/cubic mm
Interval 1.613 to 1.876
|
1.848 thousand cells/cubic mm
Interval 1.56 to 2.237
|
1.935 thousand cells/cubic mm
Interval 1.6725 to 2.1865
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day42
|
—
|
—
|
1.583 thousand cells/cubic mm
Interval 1.361 to 1.879
|
1.85 thousand cells/cubic mm
Interval 1.415 to 2.313
|
1.93 thousand cells/cubic mm
Interval 1.742 to 2.144
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day70
|
2.0955 thousand cells/cubic mm
Interval 1.051 to 3.14
|
2.1495 thousand cells/cubic mm
Interval 1.712 to 2.467
|
—
|
—
|
—
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day98
|
—
|
—
|
1.589 thousand cells/cubic mm
Interval 1.534 to 1.773
|
1.8 thousand cells/cubic mm
Interval 1.461 to 2.081
|
1.98 thousand cells/cubic mm
Interval 1.6 to 2.165
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day140
|
1.574 thousand cells/cubic mm
Interval 1.168 to 1.98
|
1.9625 thousand cells/cubic mm
Interval 1.486 to 2.75
|
—
|
—
|
—
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day182
|
—
|
—
|
1.659 thousand cells/cubic mm
Interval 1.507 to 1.822
|
2.076 thousand cells/cubic mm
Interval 1.501 to 2.421
|
1.945 thousand cells/cubic mm
Interval 1.591 to 2.19
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day238
|
—
|
—
|
1.679 thousand cells/cubic mm
Interval 1.535 to 1.959
|
1.928 thousand cells/cubic mm
Interval 1.78 to 2.057
|
1.6865 thousand cells/cubic mm
Interval 1.504 to 1.8315
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Lymphocytes (1000/cubic mm)- Day334
|
—
|
—
|
1.5425 thousand cells/cubic mm
Interval 1.465 to 1.795
|
1.96 thousand cells/cubic mm
Interval 1.48 to 2.25
|
1.745 thousand cells/cubic mm
Interval 1.587 to 1.97
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Screening
|
2.22 thousand cells/cubic mm
Interval 1.862 to 2.578
|
3.848 thousand cells/cubic mm
Interval 2.875 to 5.313
|
3.568 thousand cells/cubic mm
Interval 3.403 to 3.837
|
3.648 thousand cells/cubic mm
Interval 2.77 to 4.023
|
3.41 thousand cells/cubic mm
Interval 2.965 to 4.788
|
|
WBC, Platelets, Lymphocytes, Neutrophils in Thousand Cells/Cubic mm
Neutrophils (1000/cubic mm)- Day14
|
1.7345 thousand cells/cubic mm
Interval 1.635 to 1.834
|
3.322 thousand cells/cubic mm
Interval 2.411 to 5.1
|
3.2585 thousand cells/cubic mm
Interval 2.41 to 4.0
|
3.397 thousand cells/cubic mm
Interval 3.144 to 4.141
|
3.4945 thousand cells/cubic mm
Interval 2.405 to 4.112
|
PRIMARY outcome
Timeframe: Measured through study completion, up to 31 monthsFrom the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
No Discontinuation
|
2 Participants
|
10 Participants
|
6 Participants
|
19 Participants
|
14 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Adverse Experience
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Reactogenicity Symptom
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Unable to Contact/Out of Window
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Participant Refused Vaccination
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 2.5 for part A and 8.5 for part BPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. 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 (excluding the reference antigen record which exceeds 5000 MFI etc.).
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Samples from post-enrollment visits have positive responses if they meet three criteria: (1) net MFI greater than or equal to an antigen-specific response threshold (defined as the maximum of 100 and the 95th percentile of baseline net MFI), (2) net MFI values are greater than 3 times baseline net MFI, and (3) experimental antigen MFI values are greater than 3 times baseline MFI. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=19 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=16 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
A244 D11gp120_avi
|
0 Participants
|
8 Participants
|
0 Participants
|
18 Participants
|
13 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
B.6240_D11gp120/293F
|
0 Participants
|
9 Participants
|
0 Participants
|
17 Participants
|
13 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
BJOX002_D11gp120.avi/293F
|
0 Participants
|
9 Participants
|
0 Participants
|
16 Participants
|
12 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
CNE20_D11gp120.avi/293F
|
0 Participants
|
8 Participants
|
0 Participants
|
18 Participants
|
13 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120-AE
|
0 Participants
|
9 Participants
|
0 Participants
|
17 Participants
|
13 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-001428.2.42 V1V2
|
0 Participants
|
6 Participants
|
0 Participants
|
17 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-191084_B7 V1V2
|
0 Participants
|
9 Participants
|
0 Participants
|
17 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-62357.14 V1V2
|
0 Participants
|
5 Participants
|
0 Participants
|
14 Participants
|
9 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-700010058 V1V2
|
0 Participants
|
1 Participants
|
0 Participants
|
15 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-96ZM651.02 V1v2
|
0 Participants
|
8 Participants
|
0 Participants
|
16 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-BF1266_431a_V1V2
|
0 Participants
|
5 Participants
|
0 Participants
|
17 Participants
|
8 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-CAP210.2.00.E8 V1V2
|
0 Participants
|
6 Participants
|
0 Participants
|
16 Participants
|
8 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-CM244.ec1 V1V2
|
0 Participants
|
8 Participants
|
0 Participants
|
18 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-RHPA4259.7 V1V2
|
0 Participants
|
5 Participants
|
0 Participants
|
16 Participants
|
8 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-TV1.21 V1V2
|
0 Participants
|
7 Participants
|
0 Participants
|
17 Participants
|
9 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
254008_D11gp120.avi/293F
|
0 Participants
|
8 Participants
|
0 Participants
|
18 Participants
|
13 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
51802_D11gp120.avi/293F
|
0 Participants
|
9 Participants
|
0 Participants
|
18 Participants
|
13 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
BORI_D11gp120.avi/293F
|
0 Participants
|
9 Participants
|
0 Participants
|
15 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
TT31P.2792_D11gp120.avi/293F
|
0 Participants
|
8 Participants
|
0 Participants
|
18 Participants
|
13 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120-A
|
0 Participants
|
8 Participants
|
0 Participants
|
18 Participants
|
12 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120-B
|
0 Participants
|
9 Participants
|
0 Participants
|
18 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120-C
|
0 Participants
|
9 Participants
|
0 Participants
|
17 Participants
|
12 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-7060101641 V1V2
|
0 Participants
|
6 Participants
|
0 Participants
|
17 Participants
|
10 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-BJOX002000.03.2 V1V2
|
0 Participants
|
8 Participants
|
0 Participants
|
17 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-C2101.c01_V1V2
|
0 Participants
|
6 Participants
|
0 Participants
|
17 Participants
|
11 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-Ce1086_B2 V1V2
|
0 Participants
|
8 Participants
|
0 Participants
|
18 Participants
|
13 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-TT31P.2F10.2792 V1V2
|
0 Participants
|
4 Participants
|
0 Participants
|
13 Participants
|
9 Participants
|
|
Occurrence of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70_B.CaseA_V1_V2
|
0 Participants
|
6 Participants
|
0 Participants
|
17 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 2.5 for part A and 8.5 for part BPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. 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 (excluding the reference antigen record which exceeds 5000 MFI etc.).
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. The readout is background-subtracted mean fluorescent intensity (MFI), with background adjustment for an antigen-specific plate level control. For each sample, response magnitude is net MFI, defined as experimental antigen MFI minus reference antigen MFI. Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Summary was calculated among positive responders only (positivity criteria are described in Outcome 12).
Outcome measures
| Measure |
Part A: Placebo
n=10 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=19 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=16 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
A244 D11gp120_avi
|
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
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120-AE
|
11629.5 relative fluorescence units
Interval 8498.8 to 13170.2
|
18609 relative fluorescence units
Interval 16413.8 to 22000.0
|
11534.5 relative fluorescence units
Interval 9247.5 to 19902.2
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120-B
|
3895.2 relative fluorescence units
Interval 3754.0 to 8448.8
|
10957.1 relative fluorescence units
Interval 8435.3 to 16405.2
|
13483 relative fluorescence units
Interval 8970.9 to 19446.6
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-TT31P.2F10.2792 V1V2
|
2308.4 relative fluorescence units
Interval 568.4 to 4841.8
|
1821.8 relative fluorescence units
Interval 1275.2 to 5421.5
|
1712.5 relative fluorescence units
Interval 1117.5 to 2679.0
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-TV1.21 V1V2
|
1249.8 relative fluorescence units
Interval 727.8 to 6326.6
|
3075.2 relative fluorescence units
Interval 636.5 to 8293.8
|
2528.5 relative fluorescence units
Interval 1957.0 to 3612.8
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-001428.2.42 V1V2
|
4214.6 relative fluorescence units
Interval 1287.6 to 6912.2
|
3180 relative fluorescence units
Interval 1325.5 to 8855.8
|
7208.8 relative fluorescence units
Interval 3152.6 to 14312.9
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-191084_B7 V1V2
|
14985 relative fluorescence units
Interval 942.0 to 18635.2
|
21866.8 relative fluorescence units
Interval 13914.5 to 22000.0
|
21177.8 relative fluorescence units
Interval 10583.2 to 22000.0
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
254008_D11gp120.avi/293F
|
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
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
51802_D11gp120.avi/293F
|
13847.8 relative fluorescence units
Interval 13546.5 to 22000.0
|
22000 relative fluorescence units
Interval 16922.6 to 22000.0
|
12427.5 relative fluorescence units
Interval 6267.8 to 22000.0
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
B.6240_D11gp120/293F
|
12265 relative fluorescence units
Interval 9028.5 to 18413.5
|
22000 relative fluorescence units
Interval 18193.8 to 22000.0
|
22000 relative fluorescence units
Interval 13876.8 to 22000.0
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
BJOX002_D11gp120.avi/293F
|
11645.2 relative fluorescence units
Interval 8450.2 to 15975.5
|
22000 relative fluorescence units
Interval 19076.4 to 22000.0
|
14547.1 relative fluorescence units
Interval 9620.1 to 21372.2
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
BORI_D11gp120.avi/293F
|
5944.5 relative fluorescence units
Interval 3552.0 to 8805.8
|
16031.8 relative fluorescence units
Interval 10413.1 to 20097.0
|
7429.2 relative fluorescence units
Interval 5766.5 to 12648.8
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
CNE20_D11gp120.avi/293F
|
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
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
TT31P.2792_D11gp120.avi/293F
|
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
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120-A
|
13589.6 relative fluorescence units
Interval 10025.8 to 18696.2
|
22000 relative fluorescence units
Interval 17859.0 to 22000.0
|
18287.8 relative fluorescence units
Interval 11116.1 to 21526.8
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120-C
|
12084.8 relative fluorescence units
Interval 9242.8 to 17222.0
|
22000 relative fluorescence units
Interval 18300.0 to 22000.0
|
15846.6 relative fluorescence units
Interval 11677.2 to 22000.0
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-62357.14 V1V2
|
764.8 relative fluorescence units
Interval 247.8 to 3565.2
|
1399.8 relative fluorescence units
Interval 1077.1 to 3775.1
|
2140.8 relative fluorescence units
Interval 1302.0 to 3711.5
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-700010058 V1V2
|
3103 relative fluorescence units
Interval 3103.0 to 3103.0
|
2172.2 relative fluorescence units
Interval 396.2 to 6597.9
|
11938.2 relative fluorescence units
Interval 3265.8 to 22000.0
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-7060101641 V1V2
|
402.6 relative fluorescence units
Interval 289.4 to 2538.8
|
1176.2 relative fluorescence units
Interval 842.5 to 2095.5
|
1217.4 relative fluorescence units
Interval 681.6 to 2033.7
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-96ZM651.02 V1v2
|
10010.6 relative fluorescence units
Interval 300.6 to 21457.8
|
12543.9 relative fluorescence units
Interval 8143.1 to 22000.0
|
11192.5 relative fluorescence units
Interval 6121.4 to 20222.1
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-BF1266_431a_V1V2
|
808 relative fluorescence units
Interval 560.2 to 5568.8
|
3456 relative fluorescence units
Interval 641.0 to 9020.8
|
2003.5 relative fluorescence units
Interval 1455.2 to 3187.4
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-BJOX002000.03.2 V1V2
|
6452.2 relative fluorescence units
Interval 1076.9 to 11295.9
|
17549.8 relative fluorescence units
Interval 6772.8 to 22000.0
|
7962.2 relative fluorescence units
Interval 4547.6 to 15902.6
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-C2101.c01_V1V2
|
14362 relative fluorescence units
Interval 5960.7 to 20792.3
|
11920.5 relative fluorescence units
Interval 6894.0 to 22000.0
|
7065.8 relative fluorescence units
Interval 2127.5 to 18989.5
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-CAP210.2.00.E8 V1V2
|
1596.2 relative fluorescence units
Interval 494.2 to 4094.9
|
1571.4 relative fluorescence units
Interval 487.8 to 5566.1
|
1641 relative fluorescence units
Interval 1030.9 to 2463.3
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-CM244.ec1 V1V2
|
22000 relative fluorescence units
Interval 18385.9 to 22000.0
|
22000 relative fluorescence units
Interval 22000.0 to 22000.0
|
22000 relative fluorescence units
Interval 13074.6 to 22000.0
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-Ce1086_B2 V1V2
|
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 10914.2 to 22000.0
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70-RHPA4259.7 V1V2
|
782.5 relative fluorescence units
Interval 766.2 to 3177.2
|
2845.1 relative fluorescence units
Interval 1565.3 to 5682.8
|
1575.6 relative fluorescence units
Interval 1293.6 to 2538.4
|
—
|
—
|
|
Levels of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70_B.CaseA_V1_V2
|
1177 relative fluorescence units
Interval 613.9 to 5457.7
|
4071 relative fluorescence units
Interval 2531.0 to 10252.8
|
4955.8 relative fluorescence units
Interval 1717.6 to 13117.4
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 2.5 for part A and 8.5 for part BPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. 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 (excluding the reference antigen record which exceeds 5000 MFI etc.).
Serum IgG responses were measured on a Bio-Plex instrument using a standardized custom Luminex assay. Magnitude-breadth (MB) curves characterized the magnitude (Binding antibody MFI\* at 1:50 dilution and titer) and breadth (number of antigens with positive response at given MFI\* or titer) of each individual plasma sample assayed against a panel of antigens. The x-axis represents the response magnitude and the y-axis represents the fraction of antigens with response magnitude greater than the x-axis value. In addition to the individual sample specific curves, the group-specific curve displayed the average MB across all participants in that group. The area-under-the-magnitude-breadth curve (AUC-MB) was calculated as the average of the log10 MFI\* (log10 titer) over the panel of antigens.
Outcome measures
| Measure |
Part A: Placebo
n=2 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=19 Participants
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=16 Participants
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp120 Breadth Panel
|
2 log10 titer* proportion of antigens
Interval 2.0 to 2.0
|
4 log10 titer* proportion of antigens
Interval 3.9 to 4.1
|
2 log10 titer* proportion of antigens
Interval 2.0 to 2.0
|
4.2 log10 titer* proportion of antigens
Interval 4.1 to 4.4
|
4 log10 titer* proportion of antigens
Interval 3.4 to 4.1
|
|
Breadth of IgG HIV-1 Env-specific IgG Responses Two Weeks After the Last Vaccination
gp70 V1V2 Breadth Panel
|
2 log10 titer* proportion of antigens
Interval 2.0 to 2.0
|
2.7 log10 titer* proportion of antigens
Interval 2.5 to 3.1
|
2 log10 titer* proportion of antigens
Interval 2.0 to 2.0
|
3.3 log10 titer* proportion of antigens
Interval 3.0 to 3.6
|
3.2 log10 titer* proportion of antigens
Interval 2.3 to 3.5
|
SECONDARY outcome
Timeframe: Measured at Month 8.5 for part B onlyPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available Neutralizing Antibody data after filtering for assay specific quality control criteria.
Neutralizing antibodies against HIV1were measured as a function of reductions in Tat-regulatedluciferase (Luc) reporter gene expression in TZM-blcells. The assay performed in TZM-bl cells measured neutralization titers against a panel of Env-pseudotyped viruses that exhibit the following naturalization phenotypes. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (ID50 and ID80, cells only). The prespecified cutoff was 20 for MW965.26 (Tier 1a) and 10 for other viruses.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=19 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=16 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
92UG037.1 (ID50)
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
92UG037.1 (ID80)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
MW965.26 (ID50)
|
0 Participants
|
16 Participants
|
15 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
1056-10.TA11.1826 (ID50)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
6535.3 (ID50)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Bx08.16 (ID50)
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Q23.17 (ID50)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
ZM197M.PB7 (ID50)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
JR-FL (ID50)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
MW965.26 (ID80)
|
0 Participants
|
16 Participants
|
14 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
1056-10.TA11.1826 (ID80)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
6535.3 (ID80)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Bx08.16 (ID80)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Q23.17 (ID80)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
ZM197M.PB7 (ID80)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Part B: Occurrence of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
JR-FL (ID80)
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 8.5 for part B onlyPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 2.5 for part A and Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available Neutralizing Antibody data after filtering for assay specific quality control criteria.
Neutralizing antibodies against HIV1were measured as a function of reductions in Tat-regulatedluciferase (Luc) reporter gene expression in TZM-blcells. The assay performed in TZM-bl cells measured neutralization titers against a panel of Env-pseudotyped viruses that exhibit the following naturalization phenotypes. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (ID50 and ID80, cells only). The prespecified cutoff was 20 for MW965.26 (Tier 1a) and 10 for other viruses.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=19 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=16 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
1056-10.TA11.1826 (ID50)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Bx08.16 (ID50)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
ZM197M.PB7 (ID50)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
MW965.26 (ID50)
|
10 Titers
Interval 10.0 to 10.0
|
681.2 Titers
Interval 327.4 to 906.1
|
583.5 Titers
Interval 227.2 to 1306.6
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
6535.3 (ID50)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Q23.17 (ID50)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
92UG037.1 (ID50)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
JR-FL (ID50)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
MW965.26 (ID80)
|
10 Titers
Interval 10.0 to 10.0
|
233.7 Titers
Interval 100.9 to 331.0
|
181 Titers
Interval 74.2 to 426.3
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
1056-10.TA11.1826 (ID80)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
6535.3 (ID80)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Bx08.16 (ID80)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
Q23.17 (ID80)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
ZM197M.PB7 (ID80)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
92UG037.1 (ID80)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
|
Part B: Levels of Serum Neutralizing Antibody Responses Against Tier 1A, Tier 1B, and Selected Tier 2 Viruses Two Weeks After the Last Vaccination
JR-FL (ID80)
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
5 Titers
Interval 5.0 to 5.0
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 8.5 for part B onlyPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. The "Number Analyzed" in the Outcome Measure Data Table shows the number of participants with available BAMA, or ADCC data after filtering for assay specific quality control criteria. Assay data were not collected for gp120 IgA per lab study plan.
For Binding Antibody Multiplex Assay, gp70-V1V2 IgG, the area-under-the-magnitude-breadth curve (AUC-MB) was calculated as the average of the log10 MFI\* (log10 titer) over the panel of antigens. For ADCC GranToxiLux, AUC-MB was calculated as the average of the AUC over the panel of antigens, where AUC is defined as nonparametric area under the net percent granzyme B activity vs log10 (dilution) curve ("AUC"), calculated using the trapezoidal rule, and setting any net percent granzyme B activity below 0% to 0%. For ADCC Luciferase, (AUC-MB) was calculated as the average of the pAUC over the panel of antigens, where pAUC is defined as nonparametric partial area under the baseline subtracted curves ("pAUC"), calculated using the trapezoidal rule on the first four dilutions of the baseline subtracted curves, setting baseline subtracted loss Luciferase activity less than 0% to zero.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=19 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=16 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B
ADCC GranToxiLux against HIV-1 subtypes A, B, C and A/E
|
0.2 log10 titer* proportion of antigens
Interval 0.1 to 0.6
|
19 log10 titer* proportion of antigens
Interval 13.9 to 25.0
|
11.4 log10 titer* proportion of antigens
Interval 7.1 to 16.3
|
—
|
—
|
|
Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B
gp70 V1V2 IgG
|
2 log10 titer* proportion of antigens
Interval 2.0 to 2.0
|
3.3 log10 titer* proportion of antigens
Interval 3.0 to 3.6
|
3.2 log10 titer* proportion of antigens
Interval 2.3 to 3.5
|
—
|
—
|
|
Breadth of gp70-V1V2 IgG and gp120 IgA, Assessed by Binding Antibody Multiplex Assay, and ADCC Activities Against HIV-1 Subtypes A, B, C and A/E Two Weeks After the Last Vaccination in Part B
ADCC Luciferase against HIV-1 subtypes A, B, C and A/E
|
2.2 log10 titer* proportion of antigens
Interval 1.3 to 2.9
|
31.8 log10 titer* proportion of antigens
Interval 19.3 to 45.8
|
17.8 log10 titer* proportion of antigens
Interval 10.5 to 28.7
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 8.5 for part B onlyPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. 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.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=19 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=16 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ENV-2-PTEG-SEQ
|
0 Participants
|
16 Participants
|
4 Participants
|
—
|
—
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ANY ENV PTEG
|
0 Participants
|
19 Participants
|
7 Participants
|
—
|
—
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ANY GAG PTEG
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ENV-1-PTEG-SEQ
|
0 Participants
|
17 Participants
|
7 Participants
|
—
|
—
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
GAG-1-PTEG-SEQ
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
GAG-2-PTEG-SEQ
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 8.5 for part B onlyPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. 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.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=19 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=16 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ANY ENV PTEG
|
-0.011 % CD4+ T-cells
Interval -0.015 to -0.008
|
0.313 % CD4+ T-cells
Interval 0.183 to 0.386
|
0.102 % CD4+ T-cells
Interval 0.053 to 0.236
|
—
|
—
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ANY GAG PTEG
|
-0.001 % CD4+ T-cells
Interval -0.007 to 0.003
|
0.017 % CD4+ T-cells
Interval -0.004 to 0.028
|
0.001 % CD4+ T-cells
Interval -0.006 to 0.009
|
—
|
—
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ENV-1-PTEG-SEQ
|
-0.005 % CD4+ T-cells
Interval -0.009 to -0.003
|
0.166 % CD4+ T-cells
Interval 0.1 to 0.209
|
0.052 % CD4+ T-cells
Interval 0.026 to 0.131
|
—
|
—
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ENV-2-PTEG-SEQ
|
-0.007 % CD4+ T-cells
Interval -0.01 to -0.004
|
0.142 % CD4+ T-cells
Interval 0.064 to 0.194
|
0.037 % CD4+ T-cells
Interval 0.019 to 0.058
|
—
|
—
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
GAG-1-PTEG-SEQ
|
-0.001 % CD4+ T-cells
Interval -0.003 to 0.003
|
0.004 % CD4+ T-cells
Interval -0.004 to 0.018
|
-0.002 % CD4+ T-cells
Interval -0.008 to 0.005
|
—
|
—
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
GAG-2-PTEG-SEQ
|
-0.002 % CD4+ T-cells
Interval -0.004 to 0.001
|
0.009 % CD4+ T-cells
Interval 0.0 to 0.017
|
0.003 % CD4+ T-cells
Interval -0.002 to 0.006
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 8.5 for part B onlyPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. 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.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=19 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=16 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ENV-1-PTEG-SEQ
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ANY ENV PTEG
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ANY GAG PTEG
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ENV-2-PTEG-SEQ
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
GAG-1-PTEG-SEQ
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
GAG-2-PTEG-SEQ
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Measured at Month 8.5 for part B onlyPopulation: In this report, "Overall Number of Participants Analyzed" represents the HIV-uninfected participants who received the last vaccination with specimens at Month 8.5 for part B. 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.
PBMC samples are stimulated with synthetic peptide pools or left unstimulated as a negative control. For each sample, T-cell subset, and peptide pool, response magnitude is % cells expressing markers (IFNg and/or IL-2) after peptide stimulation minus % cells expressing markers after no stimulation. A contingency table is constructed to assess response: stimulation (peptide/none) vs. marker expression (yes/no). A one-sided Fisher's exact test is applied, testing if the number of cells positive for the marker is equal in the stimulated vs. unstimulated cells. A discrete Bonferroni adjustment is made over the peptide pools. Response is positive if adjusted p-value \<=0.00001. Please note the above analyses were applied by the lab to determine the response positivity, not the planned analyses for the study outcome measures. Data are excluded if blood draw date was outside the visit window, participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high.
Outcome measures
| Measure |
Part A: Placebo
n=6 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=19 Participants
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=16 Participants
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ANY GAG PTEG
|
0.002 % CD8+ T-cells
Interval -0.011 to 0.003
|
-0.006 % CD8+ T-cells
Interval -0.009 to 0.002
|
-0.004 % CD8+ T-cells
Interval -0.013 to -0.001
|
—
|
—
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ANY ENV PTEG
|
-0.003 % CD8+ T-cells
Interval -0.008 to 0.004
|
0.007 % CD8+ T-cells
Interval -0.002 to 0.013
|
-0.007 % CD8+ T-cells
Interval -0.012 to 0.0
|
—
|
—
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ENV-1-PTEG-SEQ
|
0.001 % CD8+ T-cells
Interval -0.003 to 0.004
|
0.006 % CD8+ T-cells
Interval -0.001 to 0.017
|
-0.002 % CD8+ T-cells
Interval -0.007 to 0.002
|
—
|
—
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
ENV-2-PTEG-SEQ
|
-0.002 % CD8+ T-cells
Interval -0.007 to 0.0
|
0 % CD8+ T-cells
Interval -0.008 to 0.007
|
-0.004 % CD8+ T-cells
Interval -0.006 to 0.0
|
—
|
—
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
GAG-1-PTEG-SEQ
|
0.002 % CD8+ T-cells
Interval -0.009 to 0.007
|
0 % CD8+ T-cells
Interval -0.004 to 0.002
|
-0.005 % CD8+ T-cells
Interval -0.009 to 0.0
|
—
|
—
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine Two Weeks After the Last Vaccination. Measured by Flow Cytometry.
GAG-2-PTEG-SEQ
|
0 % CD8+ T-cells
Interval -0.003 to 0.001
|
-0.004 % CD8+ T-cells
Interval -0.007 to 0.0
|
0 % CD8+ T-cells
Interval -0.005 to 0.002
|
—
|
—
|
Adverse Events
Part A: Placebo
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Part A: Vaccine
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Part B: Placebo
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Part B: Vaccine 1
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
Part B: Vaccine 2
Serious events: 0 serious events
Other events: 18 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Part A: Placebo
n=2 participants at risk
Placebo: Sodium Chloride USP 0.9% at Month (0, 2)
|
Part A: Vaccine
n=10 participants at risk
Protein/ GLA-SE at Month (0, 2)
|
Part B: Placebo
n=6 participants at risk
Placebo: Sodium Chloride USP 0.9% at Month (0, 1, 3, 6, 8)
|
Part B: Vaccine 1
n=21 participants at risk
DNA+Placebo for protein at Month(0, 1, 3), Protein/GLA-SE+Placebo for DNA at Month (6, 8)
|
Part B: Vaccine 2
n=21 participants at risk
DNA+Protein/GLA-SE at Month (0, 1, 3, 6, 8)
|
|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Ear and labyrinth disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Ear and labyrinth disorders
Eustachian tube dysfunction
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
66.7%
4/6 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
23.8%
5/21 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
14.3%
3/21 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Anal fissure
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Anal fissure haemorrhage
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Cannabinoid hyperemesis syndrome
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
33.3%
2/6 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
14.3%
3/21 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Haematemesis
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Gastrointestinal disorders
Tongue ulceration
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
General disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
19.0%
4/21 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
General disorders
Chest pain
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
General disorders
Cyst
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
General disorders
Influenza like illness
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
General disorders
Injection site pruritus
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
14.3%
3/21 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Hepatobiliary disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Hepatobiliary disorders
Hepatic cyst
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
30.0%
3/10 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
50.0%
3/6 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
47.6%
10/21 • Number of events 18 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
61.9%
13/21 • Number of events 25 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Abscess limb
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Body tinea
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Bronchitis viral
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Cellulitis
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Febrile infection
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Influenza
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Otitis media
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Pneumonia
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Sinusitis
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Tooth abscess
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
20.0%
2/10 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
38.1%
8/21 • Number of events 9 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
47.6%
10/21 • Number of events 13 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Viral infection
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
50.0%
1/2 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
14.3%
3/21 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Injury, poisoning and procedural complications
Chest injury
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Injury, poisoning and procedural complications
Nasal injury
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Injury, poisoning and procedural complications
Post procedural swelling
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Injury, poisoning and procedural complications
Procedural pain
|
50.0%
1/2 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Investigations
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
30.0%
3/10 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
23.8%
5/21 • Number of events 8 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
19.0%
4/21 • Number of events 6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Investigations
Blood creatinine increased
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
20.0%
2/10 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
19.0%
4/21 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
19.0%
4/21 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Investigations
Blood glucose increased
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Investigations
Blood pressure increased
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Investigations
Red blood cells urine positive
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
23.8%
5/21 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Limb discomfort
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Muscle twitching
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Nervous system disorders
Any Event in SOC
|
50.0%
1/2 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Nervous system disorders
Headache
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Nervous system disorders
Migraine
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Nervous system disorders
Syncope
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Nervous system disorders
Tardive dyskinesia
|
50.0%
1/2 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Psychiatric disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Psychiatric disorders
Depression
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Psychiatric disorders
Nightmare
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Renal and urinary disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 4 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Renal and urinary disorders
Glycosuria
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Renal and urinary disorders
Proteinuria
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Reproductive system and breast disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Reproductive system and breast disorders
Breast pain
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Reproductive system and breast disorders
Menorrhagia
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
50.0%
1/2 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
14.3%
3/21 • Number of events 3 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Respiratory, thoracic and mediastinal disorders
Upper-airway cough syndrome
|
50.0%
1/2 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
50.0%
1/2 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
19.0%
4/21 • Number of events 5 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
23.8%
5/21 • Number of events 6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
9.5%
2/21 • Number of events 2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Ecchymosis
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
10.0%
1/10 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Hyperhidrosis
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Hyperkeratosis
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Rash
|
50.0%
1/2 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Rash erythematous
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Rash maculo-papular
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Skin and subcutaneous tissue disorders
Skin hyperpigmentation
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
16.7%
1/6 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Vascular disorders
Any Event in SOC
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
|
Vascular disorders
Flushing
|
0.00%
0/2 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/10 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/6 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
4.8%
1/21 • Number of events 1 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
0.00%
0/21 • Serious Adverse events are collected throughout the study (months 0-8 for Part A, and months 0-14 for Part B). Non-serious adverse events are collected through 30 days after each vaccination (at months 0,2 for Part A, and months 0, 1, 3, 6, 8 for Part B).
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place