Trial Outcomes & Findings for Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205 (NCT NCT02852005)
NCT ID: NCT02852005
Last Updated: 2022-08-08
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
27 participants
Primary outcome timeframe
Measured through 3 days after the boost at Month 0 and Month 4
Results posted on
2022-08-08
Participant Flow
Participant milestones
| Measure |
Group 1: Boost
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
4
|
6
|
6
|
7
|
|
Overall Study
Month 0.5
|
3
|
4
|
6
|
6
|
7
|
|
Overall Study
Month 4.5
|
3
|
4
|
6
|
6
|
7
|
|
Overall Study
Month 10
|
3
|
3
|
6
|
5
|
7
|
|
Overall Study
COMPLETED
|
3
|
4
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Boost
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
0
|
0
|
1
|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
Evaluating the Immunogenicity of the AIDSVAX B/E Vaccine and the MVA/HIV62B Vaccine in Healthy, HIV-1-Uninfected Adults Who Previously Received MVA/HIV62B in DNA/MVA or MVA/MVA Regimens in HVTN 205
Baseline characteristics by cohort
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
32 years
n=5 Participants
|
32 years
n=7 Participants
|
32 years
n=5 Participants
|
30 years
n=4 Participants
|
36 years
n=21 Participants
|
33 years
n=10 Participants
|
|
Age, Customized
Less than 18
|
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=10 Participants
|
|
Age, Customized
18 - 20
|
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=10 Participants
|
|
Age, Customized
21 - 30
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
|
Age, Customized
31 - 40
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
14 Participants
n=10 Participants
|
|
Age, Customized
41 - 50
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Age, Customized
Over 50
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 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=10 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
16 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
16 Participants
n=10 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=10 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=10 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 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=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
11 Participants
n=10 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
17 Participants
n=10 Participants
|
|
Region of Enrollment
Peru
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
10 Participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after the boost at Month 0 and Month 4Population: The "overall number of participants analyzed" represents participants enrolled and received MVA/HIV62B or placebo. However, one participant in T5 received MVA/HIV62B placebo in the right arm. Hence no left arm reactogenicity data was collected for the participant.
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=6 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Induration · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain · None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain · Mild
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain · Moderate
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Tenderness · None
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Tenderness · Mild
|
3 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Tenderness · Moderate
|
1 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain and/or Tenderness · None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain and/or Tenderness · Mild
|
1 Participants
|
0 Participants
|
3 Participants
|
5 Participants
|
3 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain and/or Tenderness · Moderate
|
3 Participants
|
4 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
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 of the Left Arm (MVA/HIV62B or Placebo)
Erythema · None
|
4 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Erythema · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Erythema · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Erythema · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Erythema · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Induration · None
|
4 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Induration · Moderate
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Erythema and/or Induration · None
|
4 Participants
|
4 Participants
|
3 Participants
|
6 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Erythema and/or Induration · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Erythema and/or Induration · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Left Arm (MVA/HIV62B or Placebo)
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 the boost at Month 0 and Month 4Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain and/or Tenderness · None
|
3 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain and/or Tenderness · Moderate
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain · None
|
3 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain · Mild
|
0 Participants
|
4 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Tenderness · None
|
3 Participants
|
0 Participants
|
5 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Tenderness · Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Tenderness · Moderate
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain and/or Tenderness · Mild
|
0 Participants
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
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 of the Right Arm (AIDSVAX B/E or Placebo)
Erythema · None
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Induration · None
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Induration · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Induration · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema and/or Induration · None
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema and/or Induration · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema and/or Induration · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms of the Right Arm (AIDSVAX B/E or Placebo)
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Month Measured through 3 days after each boost at Month 0 and 4Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.0 \[November 2014\], The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Myalgia · None
|
1 Participants
|
1 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Myalgia · Mild
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Myalgia · Moderate
|
3 Participants
|
2 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Malaise and/or fatigue · None
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Malaise and/or fatigue · Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Malaise and/or fatigue · Moderate
|
2 Participants
|
2 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
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 During the Boost Regimen
Headache · None
|
1 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Headache · Mild
|
2 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Headache · Moderate
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Nausea · None
|
3 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Nausea · Mild
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Vomiting · None
|
4 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Vomiting · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Chills · None
|
2 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Chills · Mild
|
1 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Chills · Moderate
|
1 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Arthralgia · None
|
2 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Arthralgia · Mild
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Arthralgia · Moderate
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Max. Systemic Symptoms · None
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Max. Systemic Symptoms · Mild
|
1 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Max. Systemic Symptoms · Moderate
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
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 During the Boost Regimen
Temperature · None
|
3 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
6 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Temperature · Mild
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Temperature · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms During the Boost Regimen
Temperature · Potentially Life-threatening
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through Month 10From the study termination form, early termination reasons associated with an AE or reactogenicity are tabulated by treatment arm
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Adverse event or reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
No adverse event or reactogenicity
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
Do not know
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Early Study Termination Associated With an AE or Reactogenicity
No termination
|
3 Participants
|
4 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through the Month 4 boostFrom the study product discontinuation form, study product administration reasons are tabulated by treatment arm
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Clinical Event
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Reactogenicity
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
Other reason
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
|
Number of Participants With Study Product Discontinuation Associated With an AE or Reactogenicity
No discontinuation
|
3 Participants
|
3 Participants
|
6 Participants
|
6 Participants
|
7 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each boost at Month 0 and 4Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Screening
|
54.5 U/L
Interval 50.5 to 61.0
|
63.5 U/L
Interval 48.5 to 66.5
|
91 U/L
Interval 52.0 to 99.0
|
78.5 U/L
Interval 45.0 to 99.0
|
55 U/L
Interval 39.0 to 112.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day14
|
59 U/L
Interval 56.0 to 59.0
|
68.5 U/L
Interval 49.5 to 74.5
|
73 U/L
Interval 58.0 to 101.0
|
57 U/L
Interval 40.0 to 83.0
|
52 U/L
Interval 38.0 to 105.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
Alkaline Phosphatase (U/L)- Day126
|
58 U/L
Interval 55.0 to 69.0
|
63 U/L
Interval 45.5 to 77.0
|
69 U/L
Interval 64.0 to 73.0
|
72 U/L
Interval 40.0 to 84.0
|
53 U/L
Interval 38.0 to 73.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Screening
|
16.5 U/L
Interval 12.5 to 21.5
|
16.5 U/L
Interval 14.0 to 20.0
|
20 U/L
Interval 17.0 to 30.0
|
17.5 U/L
Interval 15.0 to 20.0
|
24 U/L
Interval 20.0 to 25.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day14
|
18 U/L
Interval 14.0 to 28.0
|
15.5 U/L
Interval 13.5 to 21.0
|
26 U/L
Interval 18.0 to 27.0
|
21 U/L
Interval 18.0 to 22.0
|
24 U/L
Interval 18.0 to 30.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
AST (U/L)- Day126
|
18 U/L
Interval 13.0 to 25.0
|
19 U/L
Interval 16.5 to 21.5
|
17 U/L
Interval 15.0 to 25.0
|
22.5 U/L
Interval 20.0 to 26.0
|
22 U/L
Interval 18.0 to 28.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Screening
|
15.5 U/L
Interval 11.5 to 22.5
|
16.5 U/L
Interval 13.5 to 20.0
|
23 U/L
Interval 14.0 to 32.0
|
14.5 U/L
Interval 13.0 to 23.0
|
26 U/L
Interval 15.0 to 32.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day14
|
18 U/L
Interval 10.0 to 20.0
|
16 U/L
Interval 12.5 to 19.5
|
23 U/L
Interval 16.0 to 29.0
|
21.5 U/L
Interval 16.0 to 25.0
|
23 U/L
Interval 13.0 to 34.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Alkaline Phosphatase, AST, ALT in U/L
ALT (SGPT) (U/L)- Day126
|
14 U/L
Interval 9.0 to 16.0
|
15.5 U/L
Interval 14.5 to 23.5
|
16.5 U/L
Interval 16.0 to 29.0
|
22.5 U/L
Interval 15.0 to 37.0
|
28 U/L
Interval 15.0 to 37.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each boost at Month 0 and 4Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Screening
|
14 g/dL
Interval 12.75 to 14.95
|
13.6 g/dL
Interval 12.95 to 14.05
|
13 g/dL
Interval 12.3 to 15.8
|
14.5 g/dL
Interval 13.8 to 15.1
|
14 g/dL
Interval 12.2 to 15.1
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day14
|
15 g/dL
Interval 11.4 to 15.6
|
13.55 g/dL
Interval 13.15 to 14.05
|
12.85 g/dL
Interval 12.5 to 14.6
|
14.05 g/dL
Interval 13.0 to 14.9
|
12.9 g/dL
Interval 12.1 to 14.7
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Hemoglobin (g/dL)- Day126
|
14.9 g/dL
Interval 11.3 to 15.8
|
13.9 g/dL
Interval 13.65 to 14.15
|
13.2 g/dL
Interval 12.2 to 14.5
|
14.65 g/dL
Interval 13.7 to 14.8
|
12.8 g/dL
Interval 12.2 to 14.3
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Screening
|
0.000785 g/dL
Interval 0.00075 to 0.00085
|
0.000805 g/dL
Interval 0.000715 to 0.000845
|
0.00072 g/dL
Interval 0.00071 to 0.0009
|
0.000755 g/dL
Interval 0.00063 to 0.00088
|
0.00085 g/dL
Interval 0.00055 to 0.00091
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day14
|
0.0008 g/dL
Interval 0.00068 to 0.0008
|
0.000795 g/dL
Interval 0.000765 to 0.000865
|
0.0008 g/dL
Interval 0.00072 to 0.00099
|
0.000835 g/dL
Interval 0.00053 to 0.00093
|
0.00092 g/dL
Interval 0.00063 to 0.00096
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: Hemoglobin, Creatinine in g/dL
Creatinine (g/dL)- Day126
|
0.0009 g/dL
Interval 0.00077 to 0.00094
|
0.00075 g/dL
Interval 0.000715 to 0.00079
|
0.000725 g/dL
Interval 0.00064 to 0.0009
|
0.000785 g/dL
Interval 0.0006 to 0.00091
|
0.00085 g/dL
Interval 0.0006 to 0.0009
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured during screening, and 2 weeks after each boost at Month 0 and 4Population: 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.
For each chemistry laboratory measure, summary statistics were presented by analyte and treatment group for the overall population.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (cells/cubic mm)- Screening
|
1423.5 thousand cells/cubic mm
Interval 1144.0 to 2256.0
|
2426 thousand cells/cubic mm
Interval 1785.0 to 3111.0
|
2042 thousand cells/cubic mm
Interval 1420.0 to 2400.0
|
2055.5 thousand cells/cubic mm
Interval 1557.0 to 2268.0
|
1950 thousand cells/cubic mm
Interval 1566.0 to 2262.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (cells/cubic mm)- Day14
|
1449 thousand cells/cubic mm
Interval 920.0 to 2991.0
|
2483.5 thousand cells/cubic mm
Interval 1825.0 to 2913.5
|
2153.5 thousand cells/cubic mm
Interval 1980.0 to 2300.0
|
1798 thousand cells/cubic mm
Interval 1512.0 to 2268.0
|
2075 thousand cells/cubic mm
Interval 1779.0 to 2220.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Lymphocytes (cells/cubic mm)- Day126
|
1855 thousand cells/cubic mm
Interval 1580.0 to 3089.0
|
2670 thousand cells/cubic mm
Interval 1770.0 to 2922.0
|
2084 thousand cells/cubic mm
Interval 1891.0 to 2688.0
|
1800 thousand cells/cubic mm
Interval 1617.0 to 2129.0
|
1652 thousand cells/cubic mm
Interval 1370.0 to 2592.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (cells/cubic mm)- Day126
|
4473 thousand cells/cubic mm
Interval 2204.0 to 6710.0
|
4162.5 thousand cells/cubic mm
Interval 2037.5 to 6545.0
|
4254.5 thousand cells/cubic mm
Interval 3320.0 to 5800.0
|
2364 thousand cells/cubic mm
Interval 2201.0 to 3720.0
|
3584 thousand cells/cubic mm
Interval 2590.0 to 4455.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)- Screening
|
5.8 thousand cells/cubic mm
Interval 5.45 to 7.23
|
6.27 thousand cells/cubic mm
Interval 4.115 to 8.65
|
6.875 thousand cells/cubic mm
Interval 5.87 to 8.0
|
6.4 thousand cells/cubic mm
Interval 5.5 to 7.1
|
5.8 thousand cells/cubic mm
Interval 4.84 to 8.7
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)- Day14
|
6.3 thousand cells/cubic mm
Interval 4.3 to 9.97
|
6.5 thousand cells/cubic mm
Interval 4.745 to 9.225
|
7.555 thousand cells/cubic mm
Interval 5.91 to 8.9
|
5.65 thousand cells/cubic mm
Interval 4.7 to 8.4
|
7.4 thousand cells/cubic mm
Interval 4.27 to 7.98
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
WBC (1000/cubic mm)- Day126
|
7 thousand cells/cubic mm
Interval 4.4 to 10.65
|
7.47 thousand cells/cubic mm
Interval 4.56 to 9.875
|
7.25 thousand cells/cubic mm
Interval 5.55 to 9.62
|
4.85 thousand cells/cubic mm
Interval 4.2 to 6.0
|
5.6 thousand cells/cubic mm
Interval 4.47 to 8.1
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)- Screening
|
220.8 thousand cells/cubic mm
Interval 195.0 to 239.3
|
256.5 thousand cells/cubic mm
Interval 216.5 to 287.5
|
329.85 thousand cells/cubic mm
Interval 295.0 to 368.0
|
269.5 thousand cells/cubic mm
Interval 247.0 to 296.0
|
266 thousand cells/cubic mm
Interval 191.0 to 320.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)- Day14
|
251 thousand cells/cubic mm
Interval 152.0 to 252.2
|
309.5 thousand cells/cubic mm
Interval 253.0 to 383.5
|
325.6 thousand cells/cubic mm
Interval 308.0 to 338.0
|
306 thousand cells/cubic mm
Interval 271.0 to 321.0
|
267 thousand cells/cubic mm
Interval 211.0 to 340.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Platelets (1000/cubic mm)- Day126
|
234.5 thousand cells/cubic mm
Interval 179.0 to 244.0
|
259 thousand cells/cubic mm
Interval 229.5 to 347.0
|
340 thousand cells/cubic mm
Interval 314.0 to 359.0
|
279 thousand cells/cubic mm
Interval 254.0 to 296.0
|
285 thousand cells/cubic mm
Interval 228.0 to 373.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (cells/cubic mm)- Screening
|
4151.5 thousand cells/cubic mm
Interval 3545.0 to 4694.0
|
3260 thousand cells/cubic mm
Interval 1777.0 to 4740.0
|
4195 thousand cells/cubic mm
Interval 3690.0 to 4960.0
|
3803 thousand cells/cubic mm
Interval 2806.0 to 4261.0
|
3229 thousand cells/cubic mm
Interval 2770.0 to 4823.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures, for Each Boost: WBC, Platelets, Lymphocytes, Neutrophils
Neutrophils (cells/cubic mm)- Day14
|
4190 thousand cells/cubic mm
Interval 2636.0 to 6281.0
|
3855 thousand cells/cubic mm
Interval 2076.0 to 5785.0
|
4759.5 thousand cells/cubic mm
Interval 3290.0 to 4895.0
|
3587.5 thousand cells/cubic mm
Interval 2820.0 to 4704.0
|
4187 thousand cells/cubic mm
Interval 2390.0 to 4944.0
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured at Month 0.5 and 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific 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. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 0.5
|
1 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
3 Participants
|
7 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 4.5
|
0 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
7 Participants
|
2 Participants
|
7 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 0.5
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 4.5
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
7 Participants
|
6 Participants
|
7 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 0.5
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 4.5
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
7 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp70_B.CaseA_V1_V2 at Month 0.5
|
1 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
5 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp70_B.CaseA_V1_V2 at Month 4.5
|
2 Participants
|
2 Participants
|
0 Participants
|
6 Participants
|
6 Participants
|
2 Participants
|
8 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 0.5 and 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific 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. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 0.5
|
220.875 fluorescence unit relative to background
Interval 1.0 to 440.75
|
8614 fluorescence unit relative to background
Interval 5879.0 to 26686.25
|
196 fluorescence unit relative to background
Interval 74.75 to 244.75
|
28087 fluorescence unit relative to background
Interval 26883.5 to 29222.25
|
23785.75 fluorescence unit relative to background
Interval 5630.25 to 27778.5
|
196 fluorescence unit relative to background
Interval 1.0 to 246.0
|
26686.25 fluorescence unit relative to background
Interval 8614.0 to 28563.75
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 4.5
|
83.25 fluorescence unit relative to background
Interval 41.5 to 125.0
|
5747.5 fluorescence unit relative to background
Interval 2239.0 to 22439.0
|
172 fluorescence unit relative to background
Interval 112.875 to 288.0
|
24074.75 fluorescence unit relative to background
Interval 22735.25 to 27543.625
|
18736.75 fluorescence unit relative to background
Interval 15876.75 to 27143.75
|
139 fluorescence unit relative to background
Interval 72.75 to 191.0
|
22439 fluorescence unit relative to background
Interval 5747.5 to 24689.75
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp70_B.CaseA_V1_V2 at Month 0.5
|
565.125 fluorescence unit relative to background
Interval 15.0 to 1115.25
|
87.25 fluorescence unit relative to background
Interval 1.0 to 1985.75
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
1045.875 fluorescence unit relative to background
Interval 23.25 to 26299.0
|
181.75 fluorescence unit relative to background
Interval 1.0 to 4502.0
|
1 fluorescence unit relative to background
Interval 1.0 to 15.0
|
611.75 fluorescence unit relative to background
Interval 23.25 to 1985.75
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 0.5
|
17731.875 fluorescence unit relative to background
Interval 4716.5 to 30747.25
|
32346.75 fluorescence unit relative to background
Interval 29849.0 to 32654.25
|
14689.25 fluorescence unit relative to background
Interval 10853.125 to 17512.5
|
31583.375 fluorescence unit relative to background
Interval 31444.875 to 32142.75
|
30936.5 fluorescence unit relative to background
Interval 27708.25 to 31563.5
|
14689.25 fluorescence unit relative to background
Interval 8404.0 to 18948.75
|
31707.5 fluorescence unit relative to background
Interval 31430.5 to 32578.0
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 4.5
|
14087.75 fluorescence unit relative to background
Interval 7946.25 to 20229.25
|
25825.5 fluorescence unit relative to background
Interval 25002.5 to 32600.25
|
23503.125 fluorescence unit relative to background
Interval 15374.375 to 25633.75
|
30404.5 fluorescence unit relative to background
Interval 29352.5 to 31714.75
|
28886.5 fluorescence unit relative to background
Interval 21889.0 to 30798.25
|
21358.125 fluorescence unit relative to background
Interval 8261.75 to 24519.25
|
29998.5 fluorescence unit relative to background
Interval 25825.5 to 32600.25
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 0.5
|
19616.625 fluorescence unit relative to background
Interval 6577.75 to 32655.5
|
32345 fluorescence unit relative to background
Interval 29809.0 to 32647.25
|
17144.25 fluorescence unit relative to background
Interval 9655.625 to 26767.375
|
27552.75 fluorescence unit relative to background
Interval 15555.375 to 30144.875
|
2412.5 fluorescence unit relative to background
Interval 296.75 to 7347.0
|
17144.25 fluorescence unit relative to background
Interval 8024.5 to 30533.0
|
29809 fluorescence unit relative to background
Interval 27392.5 to 32576.75
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 4.5
|
18819.125 fluorescence unit relative to background
Interval 10370.5 to 27267.75
|
31713 fluorescence unit relative to background
Interval 28452.25 to 32588.5
|
24536.5 fluorescence unit relative to background
Interval 12926.25 to 29876.375
|
27619.125 fluorescence unit relative to background
Interval 25238.5 to 29852.625
|
2084.25 fluorescence unit relative to background
Interval 245.0 to 5110.0
|
23852.25 fluorescence unit relative to background
Interval 10370.5 to 28636.25
|
28452.25 fluorescence unit relative to background
Interval 27056.75 to 31713.0
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp70_B.CaseA_V1_V2 at Month 4.5
|
605.5 fluorescence unit relative to background
Interval 332.25 to 878.75
|
15735 fluorescence unit relative to background
Interval 1.0 to 23942.5
|
1 fluorescence unit relative to background
Interval 1.0 to 3.25
|
4909 fluorescence unit relative to background
Interval 3774.75 to 10989.75
|
11250.75 fluorescence unit relative to background
Interval 2338.75 to 25894.5
|
3.25 fluorescence unit relative to background
Interval 1.0 to 332.25
|
4948.75 fluorescence unit relative to background
Interval 3774.75 to 15735.0
|
PRIMARY outcome
Timeframe: Measured at Month 0.5 and 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgG3 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. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 0.5
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
|
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 4.5
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
|
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 0.5
|
2 Participants
|
3 Participants
|
4 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
|
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 4.5
|
2 Participants
|
2 Participants
|
4 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
6 Participants
|
|
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 0.5
|
2 Participants
|
4 Participants
|
3 Participants
|
5 Participants
|
0 Participants
|
5 Participants
|
9 Participants
|
|
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 4.5
|
2 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
|
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp70_B.CaseA_V1_V2 at Month 0.5
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Occurrence of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp70_B.CaseA_V1_V2 at Month 4.5
|
0 Participants
|
2 Participants
|
0 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
6 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 0.5 and 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgG3 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. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 0.5
|
4137.5 fluorescence unit relative to background
Interval 234.25 to 15416.5
|
870.75 fluorescence unit relative to background
Interval 701.625 to 5744.125
|
525.875 fluorescence unit relative to background
Interval 100.5 to 12995.25
|
794.375 fluorescence unit relative to background
Interval 513.0 to 1269.75
|
41 fluorescence unit relative to background
Interval 23.0 to 56.5
|
889 fluorescence unit relative to background
Interval 162.75 to 12995.25
|
845.25 fluorescence unit relative to background
Interval 619.5 to 1269.75
|
|
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp70_B.CaseA_V1_V2 at Month 0.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
32.5 fluorescence unit relative to background
Interval 1.0 to 224.625
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
1 fluorescence unit relative to background
Interval 1.0 to 57.0
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
1 fluorescence unit relative to background
Interval 1.0 to 64.0
|
|
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp70_B.CaseA_V1_V2 at Month 4.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
92.875 fluorescence unit relative to background
Interval 22.0 to 3889.125
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
113.125 fluorescence unit relative to background
Interval 15.25 to 162.0
|
9.75 fluorescence unit relative to background
Interval 1.0 to 25.25
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
113.125 fluorescence unit relative to background
Interval 15.25 to 162.0
|
|
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 0.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
5.875 fluorescence unit relative to background
Interval 3.375 to 11.375
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
8 fluorescence unit relative to background
Interval 4.25 to 126.75
|
6 fluorescence unit relative to background
Interval 3.0 to 370.25
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
5.875 fluorescence unit relative to background
Interval 4.25 to 16.5
|
|
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 4.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
2.75 fluorescence unit relative to background
Interval 1.0 to 394.25
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
55.125 fluorescence unit relative to background
Interval 20.75 to 165.0
|
26.25 fluorescence unit relative to background
Interval 12.5 to 106.25
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
31.375 fluorescence unit relative to background
Interval 1.0 to 165.0
|
|
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 0.5
|
113.75 fluorescence unit relative to background
Interval 43.0 to 6460.5
|
236.125 fluorescence unit relative to background
Interval 134.875 to 1394.25
|
218.375 fluorescence unit relative to background
Interval 42.5 to 647.25
|
705.75 fluorescence unit relative to background
Interval 81.5 to 6505.5
|
26 fluorescence unit relative to background
Interval 14.0 to 444.0
|
129.25 fluorescence unit relative to background
Interval 43.0 to 647.25
|
236.125 fluorescence unit relative to background
Interval 81.5 to 2541.75
|
|
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 4.5
|
162.25 fluorescence unit relative to background
Interval 47.25 to 1909.25
|
230.125 fluorescence unit relative to background
Interval 14.125 to 1464.125
|
279.5 fluorescence unit relative to background
Interval 45.75 to 636.5
|
558.5 fluorescence unit relative to background
Interval 93.5 to 3852.25
|
17.5 fluorescence unit relative to background
Interval 12.0 to 56.0
|
162.25 fluorescence unit relative to background
Interval 47.25 to 636.5
|
473.875 fluorescence unit relative to background
Interval 37.75 to 2487.0
|
|
Level of Env-specific IgG3 Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 4.5
|
1338.25 fluorescence unit relative to background
Interval 181.25 to 4636.75
|
770.5 fluorescence unit relative to background
Interval 211.875 to 3107.5
|
1770.5 fluorescence unit relative to background
Interval 142.5 to 7997.5
|
1942.25 fluorescence unit relative to background
Interval 309.75 to 17175.5
|
29 fluorescence unit relative to background
Interval 21.25 to 59.0
|
1343.75 fluorescence unit relative to background
Interval 181.25 to 4636.75
|
803.5 fluorescence unit relative to background
Interval 258.75 to 4932.75
|
PRIMARY outcome
Timeframe: Measured at Month 0.5 and 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgA 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. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. IgA responses to V1V2 and the IDR of gp41 were not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 0.5
|
1 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
7 Participants
|
1 Participants
|
8 Participants
|
|
Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 4.5
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
|
Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 4.5
|
1 Participants
|
1 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
1 Participants
|
6 Participants
|
|
Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 0.5
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
2 Participants
|
1 Participants
|
3 Participants
|
|
Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 4.5
|
0 Participants
|
2 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Occurrence of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 0.5
|
0 Participants
|
3 Participants
|
0 Participants
|
4 Participants
|
6 Participants
|
0 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 0.5 and 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific IgA 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. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. IgA responses to V1V2 and the IDR of gp41 were not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 4.5
|
193.125 fluorescence unit relative to background
Interval 1.0 to 385.25
|
119.375 fluorescence unit relative to background
Interval 1.0 to 288.625
|
30.5 fluorescence unit relative to background
Interval 26.0 to 37.5
|
206.75 fluorescence unit relative to background
Interval 98.25 to 277.75
|
46.375 fluorescence unit relative to background
Interval 1.0 to 185.5
|
30.5 fluorescence unit relative to background
Interval 1.0 to 131.0
|
206.75 fluorescence unit relative to background
Interval 1.0 to 277.75
|
|
Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 4.5
|
161.375 fluorescence unit relative to background
Interval 1.0 to 321.75
|
3.625 fluorescence unit relative to background
Interval 1.0 to 4473.0
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
554.75 fluorescence unit relative to background
Interval 304.75 to 750.25
|
711.5 fluorescence unit relative to background
Interval 94.25 to 2831.25
|
1 fluorescence unit relative to background
Interval 1.0 to 6.25
|
304.75 fluorescence unit relative to background
Interval 6.25 to 750.25
|
|
Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 0.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
3035.25 fluorescence unit relative to background
Interval 110.625 to 12698.75
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
4259.75 fluorescence unit relative to background
Interval 608.25 to 13610.5
|
808.25 fluorescence unit relative to background
Interval 263.75 to 5132.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
4136.375 fluorescence unit relative to background
Interval 220.25 to 13610.5
|
|
Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con 6 gp120/B at Month 4.5
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
35.75 fluorescence unit relative to background
Interval 1.0 to 3582.125
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
482.25 fluorescence unit relative to background
Interval 241.5 to 837.25
|
571.75 fluorescence unit relative to background
Interval 14.25 to 2904.0
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
241.5 fluorescence unit relative to background
Interval 70.5 to 837.25
|
|
Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
Con S gp140 CFI at Month 0.5
|
162.5 fluorescence unit relative to background
Interval 1.0 to 324.0
|
12600.125 fluorescence unit relative to background
Interval 196.875 to 26081.25
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
12951.625 fluorescence unit relative to background
Interval 139.75 to 23511.0
|
1577.25 fluorescence unit relative to background
Interval 1095.0 to 19696.25
|
1 fluorescence unit relative to background
Interval 1.0 to 2.75
|
12951.625 fluorescence unit relative to background
Interval 139.75 to 24807.5
|
|
Level of Env-specific IgA Responses for gp120, gp41, V1V2, and the IDR of gp41 at 2 Weeks After Each Boost
gp41 at Month 0.5
|
235.5 fluorescence unit relative to background
Interval 1.0 to 470.0
|
362.5 fluorescence unit relative to background
Interval 80.625 to 708.125
|
72.75 fluorescence unit relative to background
Interval 22.5 to 127.25
|
484.875 fluorescence unit relative to background
Interval 101.75 to 1094.0
|
39.25 fluorescence unit relative to background
Interval 1.0 to 212.5
|
72.75 fluorescence unit relative to background
Interval 1.0 to 228.25
|
431.875 fluorescence unit relative to background
Interval 101.75 to 851.5
|
PRIMARY outcome
Timeframe: Measured at Month 0.5 and 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
TH023.6 at Month 4.5
|
0 Participants
|
2 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
5 Participants
|
|
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
ADA at Month 0.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
ADA at Month 4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
CM244.c01 at Month 0.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
CM244.c01 at Month 4.5
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
MN.3 at Month 0.5
|
2 Participants
|
4 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
10 Participants
|
|
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
MN.3 at Month 4.5
|
1 Participants
|
3 Participants
|
3 Participants
|
6 Participants
|
7 Participants
|
4 Participants
|
9 Participants
|
|
Occurrence of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
TH023.6 at Month 0.5
|
0 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 0.5 and 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the months 0.5 or 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Neutralizing antibodies against HIV-1 were measured as a function of reductions in Tat-regulated luciferase (Luc) reporter gene expression in TZM-bl cells. The assay measured neutralization titers against a panel of autologous and heterologous Env-pseudotyped viruses. A serum neutralization titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% (ID50) relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). Titer \< 10 is truncated at 5.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
ADA at Month 0.5
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
|
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
ADA at Month 4.5
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
|
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
CM244.c01 at Month 0.5
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
|
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
CM244.c01 at Month 4.5
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
|
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
MN.3 at Month 0.5
|
37 Dilution factor
Interval 5.0 to 60.0
|
1388.5 Dilution factor
Interval 482.5 to 12007.0
|
7.5 Dilution factor
Interval 5.0 to 16.0
|
11414.5 Dilution factor
Interval 6171.0 to 21870.0
|
6608 Dilution factor
Interval 635.0 to 14666.0
|
10 Dilution factor
Interval 5.0 to 37.0
|
7485 Dilution factor
Interval 1716.0 to 21870.0
|
|
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
MN.3 at Month 4.5
|
5 Dilution factor
Interval 5.0 to 50.0
|
196 Dilution factor
Interval 53.0 to 625.5
|
8.5 Dilution factor
Interval 5.0 to 28.0
|
944.5 Dilution factor
Interval 499.0 to 1666.0
|
996 Dilution factor
Interval 138.0 to 1285.0
|
5 Dilution factor
Interval 5.0 to 28.0
|
522.5 Dilution factor
Interval 291.0 to 1343.0
|
|
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
TH023.6 at Month 0.5
|
5 Dilution factor
Interval 5.0 to 5.0
|
5 Dilution factor
Interval 5.0 to 11.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
18 Dilution factor
Interval 5.0 to 24.0
|
5 Dilution factor
Interval 5.0 to 11.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
8.5 Dilution factor
Interval 5.0 to 24.0
|
|
Level of Neutralizing Ab Titers and Breadth Against the Env Vaccine Strain and Heterologous Tier 1 Strains at 2 Weeks After Each Boost
TH023.6 at Month 4.5
|
5 Dilution factor
Interval 5.0 to 5.0
|
80 Dilution factor
Interval 5.0 to 156.5
|
5 Dilution factor
Interval 5.0 to 5.0
|
16 Dilution factor
Interval 5.0 to 41.0
|
23 Dilution factor
Interval 5.0 to 145.0
|
5 Dilution factor
Interval 5.0 to 5.0
|
16 Dilution factor
Interval 5.0 to 98.0
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available 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 after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p\<=0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any Gag PTEg
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
8 Participants
|
7 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any Env PTEg
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
4 Participants
|
2 Participants
|
7 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any PTEg
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
4 Participants
|
8 Participants
|
7 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-1-PTEg
|
0 Participants
|
2 Participants
|
2 Participants
|
5 Participants
|
3 Participants
|
2 Participants
|
7 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-2-PTEg
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-3-PTEg
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Gag-1-PTEg
|
2 Participants
|
2 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
8 Participants
|
7 Participants
|
|
Occurrence of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Gag-2-PTEg
|
0 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
0 Participants
|
3 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available 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 after peptide stimulation minus % cells expressing markers after no stimulation. Response positivity is derived by testing if the number of cells expressing the marker is equal in the stimulated vs. unstimulated cells. Response is positive if the one-sided Fisher's exact test (discrete Bonferroni adjustment over the peptide pools) p\<=0.00001. The Fisher's exact test is not applied to compare between endpoints. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any PTEg
|
0.074 % CD4+ T-cells
Interval 0.072 to 0.142
|
0.129 % CD4+ T-cells
Interval 0.091 to 0.138
|
0.218 % CD4+ T-cells
Interval 0.141 to 0.325
|
0.338 % CD4+ T-cells
Interval 0.111 to 0.509
|
0.085 % CD4+ T-cells
Interval 0.018 to 0.148
|
0.142 % CD4+ T-cells
Interval 0.102 to 0.22
|
0.138 % CD4+ T-cells
Interval 0.111 to 0.376
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any Gag PTEg
|
0.06 % CD4+ T-cells
Interval 0.04 to 0.108
|
0.054 % CD4+ T-cells
Interval 0.035 to 0.062
|
0.163 % CD4+ T-cells
Interval 0.101 to 0.185
|
0.196 % CD4+ T-cells
Interval 0.053 to 0.272
|
0.015 % CD4+ T-cells
Interval 0.0 to 0.031
|
0.108 % CD4+ T-cells
Interval 0.06 to 0.165
|
0.062 % CD4+ T-cells
Interval 0.048 to 0.211
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-1-PTEg
|
0.007 % CD4+ T-cells
Interval 0.004 to 0.013
|
0.057 % CD4+ T-cells
Interval 0.028 to 0.082
|
0.043 % CD4+ T-cells
Interval 0.033 to 0.099
|
0.093 % CD4+ T-cells
Interval 0.058 to 0.218
|
0.045 % CD4+ T-cells
Interval 0.036 to 0.12
|
0.033 % CD4+ T-cells
Interval 0.013 to 0.045
|
0.075 % CD4+ T-cells
Interval 0.033 to 0.119
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any Env PTEg
|
0.032 % CD4+ T-cells
Interval 0.014 to 0.033
|
0.074 % CD4+ T-cells
Interval 0.05 to 0.082
|
0.048 % CD4+ T-cells
Interval 0.04 to 0.131
|
0.142 % CD4+ T-cells
Interval 0.058 to 0.218
|
0.083 % CD4+ T-cells
Interval 0.036 to 0.12
|
0.04 % CD4+ T-cells
Interval 0.033 to 0.05
|
0.082 % CD4+ T-cells
Interval 0.058 to 0.165
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-2-PTEg
|
0.032 % CD4+ T-cells
Interval 0.012 to 0.033
|
0.036 % CD4+ T-cells
Interval 0.031 to 0.053
|
0.029 % CD4+ T-cells
Interval 0.016 to 0.068
|
0.057 % CD4+ T-cells
Interval 0.047 to 0.165
|
0.077 % CD4+ T-cells
Interval 0.01 to 0.083
|
0.032 % CD4+ T-cells
Interval 0.016 to 0.035
|
0.049 % CD4+ T-cells
Interval 0.032 to 0.066
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-3-PTEg
|
0.005 % CD4+ T-cells
Interval -0.003 to 0.014
|
0.008 % CD4+ T-cells
Interval 0.008 to 0.044
|
0.025 % CD4+ T-cells
Interval 0.007 to 0.05
|
0.07 % CD4+ T-cells
Interval 0.032 to 0.139
|
0.031 % CD4+ T-cells
Interval 0.026 to 0.056
|
0.01 % CD4+ T-cells
Interval 0.005 to 0.04
|
0.037 % CD4+ T-cells
Interval 0.008 to 0.098
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Gag-1-PTEg
|
0.06 % CD4+ T-cells
Interval 0.04 to 0.108
|
0.054 % CD4+ T-cells
Interval 0.035 to 0.062
|
0.163 % CD4+ T-cells
Interval 0.101 to 0.185
|
0.196 % CD4+ T-cells
Interval 0.053 to 0.272
|
0.015 % CD4+ T-cells
Interval -0.001 to 0.031
|
0.108 % CD4+ T-cells
Interval 0.06 to 0.165
|
0.062 % CD4+ T-cells
Interval 0.048 to 0.211
|
|
Level of CD4+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Gag-2-PTEg
|
0.039 % CD4+ T-cells
Interval 0.001 to 0.058
|
0.011 % CD4+ T-cells
Interval 0.008 to 0.016
|
0.068 % CD4+ T-cells
Interval 0.059 to 0.089
|
0.134 % CD4+ T-cells
Interval 0.015 to 0.161
|
0.002 % CD4+ T-cells
Interval -0.003 to 0.02
|
0.059 % CD4+ T-cells
Interval 0.039 to 0.071
|
0.017 % CD4+ T-cells
Interval 0.01 to 0.141
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available 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 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 p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any Env PTEg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any Gag PTEg
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any PTEg
|
1 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-1-PTEg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-2-PTEg
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-3-PTEg
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Gag-1-PTEg
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Occurrence of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Gag-2-PTEg
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 4.5Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 4.5 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available 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 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 p\<=0.00001. Data are excluded if the blood draw date was outside the visit window, the participant was HIV-infected, PBMC viability or T-cell count were low, or negative control was high. The responses at month 0.5 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-3-PTEg
|
0.004 % CD8+ T-cells
Interval -0.005 to 0.007
|
-0.002 % CD8+ T-cells
Interval -0.005 to 0.0
|
-0.003 % CD8+ T-cells
Interval -0.006 to 0.005
|
-0.001 % CD8+ T-cells
Interval -0.002 to 0.02
|
-0.005 % CD8+ T-cells
Interval -0.007 to 0.002
|
-0.003 % CD8+ T-cells
Interval -0.005 to 0.005
|
-0.001 % CD8+ T-cells
Interval -0.004 to 0.0
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any Env PTEg
|
0.008 % CD8+ T-cells
Interval -0.002 to 0.013
|
0.006 % CD8+ T-cells
Interval -0.001 to 0.015
|
0.004 % CD8+ T-cells
Interval 0.003 to 0.018
|
0.015 % CD8+ T-cells
Interval 0.01 to 0.032
|
0.002 % CD8+ T-cells
Interval -0.002 to 0.006
|
0.005 % CD8+ T-cells
Interval 0.003 to 0.013
|
0.01 % CD8+ T-cells
Interval 0.004 to 0.021
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any Gag PTEg
|
0.011 % CD8+ T-cells
Interval 0.006 to 0.124
|
0.006 % CD8+ T-cells
Interval 0.0 to 0.008
|
0.004 % CD8+ T-cells
Interval 0.001 to 0.014
|
0.005 % CD8+ T-cells
Interval -0.001 to 0.025
|
0 % CD8+ T-cells
Interval -0.009 to 0.012
|
0.006 % CD8+ T-cells
Interval 0.002 to 0.014
|
0.006 % CD8+ T-cells
Interval -0.001 to 0.009
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Any PTEg
|
0.02 % CD8+ T-cells
Interval 0.018 to 0.122
|
0.009 % CD8+ T-cells
Interval 0.002 to 0.021
|
0.013 % CD8+ T-cells
Interval 0.007 to 0.037
|
0.031 % CD8+ T-cells
Interval 0.007 to 0.177
|
0.002 % CD8+ T-cells
Interval -0.003 to 0.015
|
0.018 % CD8+ T-cells
Interval 0.008 to 0.037
|
0.02 % CD8+ T-cells
Interval 0.005 to 0.035
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-1-PTEg
|
-0.003 % CD8+ T-cells
Interval -0.003 to 0.013
|
0.001 % CD8+ T-cells
Interval -0.008 to 0.007
|
-0.005 % CD8+ T-cells
Interval -0.007 to -0.003
|
-0.002 % CD8+ T-cells
Interval -0.005 to 0.003
|
-0.005 % CD8+ T-cells
Interval -0.009 to -0.005
|
-0.003 % CD8+ T-cells
Interval -0.007 to -0.003
|
-0.002 % CD8+ T-cells
Interval -0.005 to 0.003
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Env-2-PTEg
|
0.008 % CD8+ T-cells
Interval -0.002 to 0.008
|
0.006 % CD8+ T-cells
Interval -0.001 to 0.015
|
0.003 % CD8+ T-cells
Interval -0.003 to 0.003
|
0.01 % CD8+ T-cells
Interval 0.004 to 0.019
|
0.002 % CD8+ T-cells
Interval -0.002 to 0.006
|
0.003 % CD8+ T-cells
Interval -0.002 to 0.008
|
0.01 % CD8+ T-cells
Interval 0.002 to 0.019
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Gag-1-PTEg
|
0.011 % CD8+ T-cells
Interval 0.006 to 0.124
|
0.006 % CD8+ T-cells
Interval -0.002 to 0.008
|
0 % CD8+ T-cells
Interval -0.003 to 0.002
|
0.004 % CD8+ T-cells
Interval -0.001 to 0.025
|
-0.001 % CD8+ T-cells
Interval -0.009 to 0.002
|
0.002 % CD8+ T-cells
Interval 0.0 to 0.011
|
0.006 % CD8+ T-cells
Interval -0.001 to 0.009
|
|
Level of CD8+ T Cell Responses to the HIV Proteins Included in the Vaccine 2 Weeks After Each Boost
Gag-2-PTEg
|
0.011 % CD8+ T-cells
Interval -0.014 to 0.065
|
-0.003 % CD8+ T-cells
Interval -0.004 to 0.0
|
0 % CD8+ T-cells
Interval -0.002 to 0.006
|
0.001 % CD8+ T-cells
Interval -0.002 to 0.003
|
-0.006 % CD8+ T-cells
Interval -0.014 to 0.012
|
0.001 % CD8+ T-cells
Interval -0.002 to 0.011
|
-0.001 % CD8+ T-cells
Interval -0.003 to 0.003
|
SECONDARY outcome
Timeframe: Measured at Month 10Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 10 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific 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. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
Con 6 gp120/B at Month 10
|
0 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
6 Participants
|
0 Participants
|
4 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
Con S gp140 CFI at Month 10
|
2 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
7 Participants
|
6 Participants
|
5 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
gp41 at Month 10
|
2 Participants
|
2 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
5 Participants
|
4 Participants
|
|
Occurrence of Env-specific IgG Responses for gp120, gp140, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
gp70_B.CaseA_V1_V2 at Month 10
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Measured at Month 10Population: "Overall Number of Participants Analyzed" includes the HIV uninfected participants with samples collected at the month 10 immunogenicity timepoint. "Number Analyzed" shows the number of participants with available data after filtering for assay-specific quality control criteria.
Serum HIV-1-specific 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. The measure unit fluorescence units are relative to assay background, not relative to the placebo arm. Background is used here rather than negative control stimulation, since the antigens are used as bead coating rather than stimulation. The responses to the IDR of gp41 was not assayed.
Outcome measures
| Measure |
Group 1: Boost
n=4 Participants
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 Participants
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 Participants
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 Participants
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 6: Boost
n=10 Participants
MVA/HIV62B at mo(0,4)
|
Group 7: Boost
n=10 Participants
MVA/HIV62B + AIDSVAX B/E at mo(0,4)
|
|---|---|---|---|---|---|---|---|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
Con 6 gp120/B at Month 10
|
19 fluorescence unit relative to background
Interval 1.0 to 37.0
|
443.5 fluorescence unit relative to background
Interval 395.5 to 491.5
|
26.25 fluorescence unit relative to background
Interval 15.5 to 57.25
|
2206.25 fluorescence unit relative to background
Interval 718.25 to 3614.75
|
758.25 fluorescence unit relative to background
Interval 325.25 to 1500.0
|
26.25 fluorescence unit relative to background
Interval 11.75 to 37.0
|
718.25 fluorescence unit relative to background
Interval 491.5 to 2206.25
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
Con S gp140 CFI at Month 10
|
6233.25 fluorescence unit relative to background
Interval 3670.0 to 8796.5
|
5508 fluorescence unit relative to background
Interval 3314.25 to 7701.75
|
9032.375 fluorescence unit relative to background
Interval 6092.25 to 10348.375
|
13888.25 fluorescence unit relative to background
Interval 13564.75 to 28461.0
|
8258.5 fluorescence unit relative to background
Interval 2551.75 to 10231.25
|
8910 fluorescence unit relative to background
Interval 3670.0 to 9041.25
|
13564.75 fluorescence unit relative to background
Interval 7701.75 to 13888.25
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
gp41 at Month 10
|
7121.875 fluorescence unit relative to background
Interval 3533.0 to 10710.75
|
15477.25 fluorescence unit relative to background
Interval 4756.5 to 26198.0
|
9732 fluorescence unit relative to background
Interval 3583.875 to 23070.625
|
14437.5 fluorescence unit relative to background
Interval 2429.0 to 20424.0
|
492.5 fluorescence unit relative to background
Interval 104.75 to 2117.75
|
7995.875 fluorescence unit relative to background
Interval 3533.0 to 14183.0
|
14437.5 fluorescence unit relative to background
Interval 4756.5 to 20424.0
|
|
Level of Env-specific IgG Responses for gp120, gp41, V1/V2, and the IDR of gp41 at 6 Months After the Final Boost
gp70_B.CaseA_V1_V2 at Month 10
|
1 fluorescence unit relative to background
Interval 1.0 to 44.75
|
132.875 fluorescence unit relative to background
Interval 1.0 to 264.75
|
1 fluorescence unit relative to background
Interval 1.0 to 1.0
|
14.25 fluorescence unit relative to background
Interval 1.0 to 42.5
|
2.5 fluorescence unit relative to background
Interval 1.0 to 69.0
|
1 fluorescence unit relative to background
Interval 1.0 to 4.625
|
14.25 fluorescence unit relative to background
Interval 1.0 to 264.75
|
Adverse Events
Group 1: Boost
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 2: Boost
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 3: Boost
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4: Boost
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 5: Boost
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Boost
n=4 participants at risk
MVA/HIV62B mo(0,4) post HVTN 205 MMM
|
Group 2: Boost
n=4 participants at risk
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 MMM
|
Group 3: Boost
n=6 participants at risk
MVA/HIV62B mo(0,4) post HVTN 205 DDMM
|
Group 4: Boost
n=6 participants at risk
MVA/HIV62B + AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
Group 5: Boost
n=7 participants at risk
AIDSVAX B/E mo(0,4) post HVTN 205 DDMM
|
|---|---|---|---|---|---|
|
Eye disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Eye disorders
Photophobia
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Gastrointestinal disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
75.0%
3/4 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
28.6%
2/7 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Gastrointestinal disorders
Aphthous ulcer
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Gastrointestinal disorders
Duodenogastric reflux
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
General disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
General disorders
Fatigue
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Immune system disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Immune system disorders
Hypersensitivity
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Infections and infestations
Any Event in SOC
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
50.0%
2/4 • Number of events 7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
33.3%
2/6 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
42.9%
3/7 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Infections and infestations
Bacterial vaginosis
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Infections and infestations
Upper respiratory tract infection
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
50.0%
2/4 • Number of events 6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
28.6%
2/7 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Infections and infestations
Urinary tract infection bacterial
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Infections and infestations
Viral infection
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Investigations
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
33.3%
2/6 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Nervous system disorders
Any Event in SOC
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Nervous system disorders
Dizziness
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Nervous system disorders
Headache
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Psychiatric disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Renal and urinary disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
14.3%
1/7 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Reproductive system and breast disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
50.0%
2/4 • Number of events 3 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
16.7%
1/6 • Number of events 1 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
|
Skin and subcutaneous tissue disorders
Ingrowing nail
|
0.00%
0/4 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
25.0%
1/4 • Number of events 2 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/6 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
0.00%
0/7 • Serious adverse events are collected throughout the study (months 0-10). Non-serious adverse events are collected through 30 days after each vaccination (at months 0 and 4).
This table shows the number of participants reporting AEs by MedDRA preferred term and severity grade. The table was not grouped by the vaccine products because no vaccine related AE occurred.
|
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