Trial Outcomes & Findings for Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA (NCT NCT03181789)
NCT ID: NCT03181789
Last Updated: 2024-02-07
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
56 participants
Primary outcome timeframe
Measured through Month 0, 1, 3, 6
Results posted on
2024-02-07
Participant Flow
Participant milestones
| Measure |
Group 1: Vaccine
P24CE1/2(CE/CE) + gag vaccines
|
Group 2: Vaccine
P55gag (gag/gag) vaccines
|
Group 3: Control 1
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
25
|
3
|
3
|
|
Overall Study
Safety Population
|
25
|
25
|
3
|
3
|
|
Overall Study
COMPLETED
|
18
|
22
|
2
|
3
|
|
Overall Study
NOT COMPLETED
|
7
|
3
|
1
|
0
|
Reasons for withdrawal
| Measure |
Group 1: Vaccine
P24CE1/2(CE/CE) + gag vaccines
|
Group 2: Vaccine
P55gag (gag/gag) vaccines
|
Group 3: Control 1
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
|---|---|---|---|---|
|
Overall Study
Withdrawal by Subject
|
0
|
1
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
7
|
1
|
0
|
0
|
|
Overall Study
Participant unable to adhere to visit
|
0
|
1
|
0
|
0
|
Baseline Characteristics
Safety and Immunogenicity of pDNA Vaccines Expressing HIV M Group p24^Gag Conserved Elements and/or p55^Gag, Administered With IL-12 pDNA
Baseline characteristics by cohort
| Measure |
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Total
n=56 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
29 years
n=5 Participants
|
31 years
n=7 Participants
|
24 years
n=5 Participants
|
30 years
n=4 Participants
|
29 years
n=21 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
|
|
Age, Customized
18 - 20
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Age, Customized
21 - 30
|
13 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
28 Participants
n=21 Participants
|
|
Age, Customized
31 - 40
|
3 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Customized
41 - 50
|
8 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
13 Participants
n=21 Participants
|
|
Age, Customized
Over 50
|
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
|
|
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
|
|
Sex: Female, Male
Female
|
12 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
51 Participants
n=21 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
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
16 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
33 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
3 Participants
n=4 Participants
|
56 Participants
n=21 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 0, 1, 3, 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · None
|
1 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Mild
|
21 Participants
|
2 Participants
|
3 Participants
|
13 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Moderate
|
3 Participants
|
1 Participants
|
0 Participants
|
8 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Mild
|
18 Participants
|
1 Participants
|
2 Participants
|
17 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Moderate
|
7 Participants
|
2 Participants
|
1 Participants
|
8 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · None
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Mild
|
18 Participants
|
1 Participants
|
2 Participants
|
15 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Moderate
|
7 Participants
|
2 Participants
|
1 Participants
|
10 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 0, 1, 3, 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
21 Participants
|
2 Participants
|
2 Participants
|
23 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Mild
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
22 Participants
|
3 Participants
|
3 Participants
|
23 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Mild
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
20 Participants
|
2 Participants
|
2 Participants
|
22 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Mild
|
4 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 0, 1, 3, 6Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017. The maximum grade observed for each symptom ove
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
6 Participants
|
2 Participants
|
0 Participants
|
10 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
14 Participants
|
1 Participants
|
1 Participants
|
11 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
4 Participants
|
0 Participants
|
2 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
15 Participants
|
0 Participants
|
0 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
8 Participants
|
3 Participants
|
2 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
11 Participants
|
2 Participants
|
1 Participants
|
14 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
6 Participants
|
1 Participants
|
1 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
7 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
18 Participants
|
3 Participants
|
2 Participants
|
18 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
5 Participants
|
0 Participants
|
1 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
24 Participants
|
3 Participants
|
3 Participants
|
25 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
22 Participants
|
3 Participants
|
1 Participants
|
24 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
21 Participants
|
2 Participants
|
1 Participants
|
19 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
2 Participants
|
1 Participants
|
1 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
3 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
12 Participants
|
3 Participants
|
1 Participants
|
14 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
9 Participants
|
0 Participants
|
2 Participants
|
6 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
25 Participants
|
3 Participants
|
3 Participants
|
23 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 42, 98, 182 and 273Population: 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 local laboratory measure-alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK) in U/L, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
ALT (SGPT) (U/L)- Screening
|
16 U/L
Interval 13.0 to 23.0
|
12 U/L
Interval 9.0 to 15.0
|
16 U/L
Interval 13.0 to 17.0
|
17 U/L
Interval 12.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
ALT (SGPT) (U/L)-Day 14
|
16.5 U/L
Interval 11.0 to 21.0
|
9 U/L
Interval 9.0 to 9.0
|
12 U/L
Interval 10.0 to 15.0
|
14.5 U/L
Interval 11.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
ALT (SGPT) (U/L)-Day 42
|
15 U/L
Interval 12.0 to 22.0
|
12 U/L
Interval 11.0 to 13.0
|
17 U/L
Interval 11.0 to 38.0
|
14.5 U/L
Interval 10.5 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
ALT (SGPT) (U/L)-Day 98
|
13 U/L
Interval 11.0 to 22.0
|
11 U/L
Interval 11.0 to 20.0
|
16 U/L
Interval 14.0 to 20.0
|
15 U/L
Interval 11.0 to 28.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
ALT (SGPT) (U/L)-Day 182
|
17 U/L
Interval 13.0 to 21.0
|
13 U/L
Interval 12.0 to 17.0
|
13.5 U/L
Interval 10.0 to 17.0
|
16 U/L
Interval 13.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
ALT (SGPT) (U/L)-Day 273
|
15.5 U/L
Interval 12.0 to 25.5
|
11 U/L
Interval 11.0 to 11.0
|
12 U/L
Interval 12.0 to 13.0
|
16 U/L
Interval 13.0 to 22.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
AST (U/L)- Screening
|
17 U/L
Interval 15.0 to 22.0
|
18 U/L
Interval 14.0 to 20.0
|
15 U/L
Interval 12.0 to 29.0
|
17 U/L
Interval 15.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
AST (U/L)-Day 14
|
17 U/L
Interval 15.0 to 19.0
|
13.5 U/L
Interval 13.0 to 14.0
|
13 U/L
Interval 13.0 to 16.0
|
16 U/L
Interval 15.0 to 19.5
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
AST (U/L)-Day 42
|
16 U/L
Interval 15.0 to 20.0
|
14 U/L
Interval 14.0 to 19.0
|
24 U/L
Interval 13.0 to 62.0
|
16 U/L
Interval 14.0 to 20.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
AST (U/L)-Day 98
|
16 U/L
Interval 15.0 to 19.0
|
15 U/L
Interval 12.0 to 21.0
|
18 U/L
Interval 16.0 to 22.0
|
17 U/L
Interval 15.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
AST (U/L)-Day 182
|
20 U/L
Interval 15.0 to 24.0
|
17 U/L
Interval 17.0 to 20.0
|
18 U/L
Interval 15.0 to 21.0
|
18 U/L
Interval 15.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
AST (U/L)-Day 273
|
18 U/L
Interval 15.5 to 23.0
|
15.5 U/L
Interval 15.0 to 16.0
|
15 U/L
Interval 15.0 to 15.0
|
16 U/L
Interval 15.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
Alkaline Phosphatase (U/L)- Screening
|
61 U/L
Interval 52.0 to 70.0
|
52 U/L
Interval 51.0 to 55.0
|
54 U/L
Interval 43.0 to 62.0
|
61 U/L
Interval 48.0 to 72.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
Alkaline Phosphatase (U/L)-Day 14
|
57.5 U/L
Interval 53.0 to 71.5
|
52 U/L
Interval 47.0 to 57.0
|
48 U/L
Interval 42.0 to 51.0
|
61 U/L
Interval 50.0 to 71.5
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
Alkaline Phosphatase (U/L)-Day 42
|
61 U/L
Interval 50.0 to 72.0
|
51 U/L
Interval 45.0 to 66.0
|
50 U/L
Interval 42.0 to 64.0
|
55.5 U/L
Interval 49.0 to 73.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
Alkaline Phosphatase (U/L)-Day 98
|
55 U/L
Interval 49.0 to 70.0
|
51 U/L
Interval 43.0 to 61.0
|
52 U/L
Interval 44.0 to 65.0
|
54 U/L
Interval 49.0 to 72.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
Alkaline Phosphatase (U/L)-Day 182
|
56 U/L
Interval 48.0 to 74.0
|
55 U/L
Interval 48.0 to 67.0
|
61.5 U/L
Interval 56.0 to 67.0
|
59 U/L
Interval 47.0 to 70.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
Alkaline Phosphatase (U/L)-Day 273
|
55 U/L
Interval 52.5 to 66.0
|
53.5 U/L
Interval 46.0 to 61.0
|
51 U/L
Interval 44.0 to 53.0
|
57 U/L
Interval 50.0 to 64.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
creatine phosphokinase (U/L)- Screening
|
92 U/L
Interval 70.0 to 150.0
|
88 U/L
Interval 61.0 to 199.0
|
88 U/L
Interval 82.0 to 269.0
|
94 U/L
Interval 64.0 to 130.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
creatine phosphokinase (U/L)-Day 14
|
92.5 U/L
Interval 78.0 to 123.5
|
58.5 U/L
Interval 51.0 to 66.0
|
116 U/L
Interval 91.0 to 231.0
|
113.5 U/L
Interval 76.0 to 158.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
creatine phosphokinase (U/L)-Day 42
|
91 U/L
Interval 69.0 to 116.0
|
77 U/L
Interval 55.0 to 135.0
|
222 U/L
Interval 88.0 to 931.0
|
118 U/L
Interval 78.0 to 150.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
creatine phosphokinase (U/L)-Day 98
|
102 U/L
Interval 68.0 to 198.0
|
63 U/L
Interval 47.0 to 75.0
|
157 U/L
Interval 74.0 to 188.0
|
110 U/L
Interval 76.0 to 202.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
creatine phosphokinase (U/L)-Day 182
|
99 U/L
Interval 69.0 to 127.0
|
79 U/L
Interval 52.0 to 89.0
|
133 U/L
Interval 94.0 to 172.0
|
121 U/L
Interval 71.0 to 170.0
|
|
Chemistry and Hematology Laboratory Measures - Alkaline Phosphate (ALP), Aspartate Aminotransferase (AST), Alanine Aminotransferase (ALT), Creatine Phosphokinase (CPK) in U/L
creatine phosphokinase (U/L)-Day 273
|
98.5 U/L
Interval 79.0 to 175.0
|
54.5 U/L
Interval 47.0 to 62.0
|
111 U/L
Interval 56.0 to 224.0
|
123 U/L
Interval 75.0 to 219.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 42, 98, 182 and 273Population: 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 local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine in g/dL
Creatinine (g/dL)- Screening
|
0.0008 g/dL
Interval 0.00073 to 0.00087
|
0.00072 g/dL
Interval 0.00071 to 0.00085
|
0.00093 g/dL
Interval 0.00073 to 0.00095
|
0.00084 g/dL
Interval 0.00077 to 0.00103
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in g/dL
Creatinine (g/dL)-Day 14
|
0.00084 g/dL
Interval 0.00076 to 0.00094
|
0.000645 g/dL
Interval 0.00061 to 0.00068
|
0.00085 g/dL
Interval 0.00074 to 0.00095
|
0.00086 g/dL
Interval 0.00074 to 0.001
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in g/dL
Creatinine (g/dL)-Day 42
|
0.00085 g/dL
Interval 0.00075 to 0.00092
|
0.00072 g/dL
Interval 0.00059 to 0.00076
|
0.00089 g/dL
Interval 0.00078 to 0.00094
|
0.00083 g/dL
Interval 0.00076 to 0.000975
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in g/dL
Creatinine (g/dL)-Day 98
|
0.00085 g/dL
Interval 0.00077 to 0.00091
|
0.00065 g/dL
Interval 0.00059 to 0.00085
|
0.00093 g/dL
Interval 0.00077 to 0.001
|
0.00085 g/dL
Interval 0.00076 to 0.00096
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in g/dL
Creatinine (g/dL)-Day 182
|
0.00085 g/dL
Interval 0.00078 to 0.00092
|
0.00073 g/dL
Interval 0.00068 to 0.00073
|
0.00081 g/dL
Interval 0.00074 to 0.00088
|
0.00084 g/dL
Interval 0.00077 to 0.00096
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in g/dL
Creatinine (g/dL)-Day 273
|
0.00083 g/dL
Interval 0.00074 to 0.000895
|
0.00073 g/dL
Interval 0.00072 to 0.00074
|
0.00084 g/dL
Interval 0.00081 to 0.00095
|
0.00088 g/dL
Interval 0.00081 to 0.00098
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 42, 98, 182 and 273Population: 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 local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)- Screening
|
14.4 g/dL
Interval 13.8 to 15.4
|
12.6 g/dL
Interval 12.1 to 15.0
|
14.7 g/dL
Interval 13.5 to 15.4
|
14.2 g/dL
Interval 13.4 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 14
|
13.95 g/dL
Interval 13.15 to 14.85
|
13.35 g/dL
Interval 12.3 to 14.4
|
13.9 g/dL
Interval 12.5 to 14.7
|
13.8 g/dL
Interval 12.5 to 15.05
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 42
|
14 g/dL
Interval 13.0 to 14.7
|
12.7 g/dL
Interval 12.6 to 13.6
|
14.6 g/dL
Interval 13.1 to 14.9
|
14.05 g/dL
Interval 12.7 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 98
|
13.95 g/dL
Interval 13.2 to 14.7
|
12 g/dL
Interval 11.9 to 14.1
|
14.6 g/dL
Interval 11.7 to 15.1
|
14.25 g/dL
Interval 12.9 to 14.9
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 175
|
13.45 g/dL
Interval 12.8 to 14.9
|
13.4 g/dL
Interval 12.8 to 14.8
|
13.5 g/dL
Interval 11.8 to 14.9
|
13.95 g/dL
Interval 13.3 to 15.1
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 182
|
—
|
—
|
—
|
12 g/dL
Interval 11.6 to 12.4
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin (g/dL)-Day 273
|
14 g/dL
Interval 12.65 to 14.6
|
14 g/dL
Interval 13.2 to 14.8
|
14.6 g/dL
Interval 11.2 to 15.0
|
14 g/dL
Interval 12.7 to 14.7
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 42, 98, 175 and 273Population: 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 local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Neutrophils (1000*cells/mm^3)- Screening
|
3.564 1000*cells/mm^3
Interval 2.688 to 4.614
|
3.16 1000*cells/mm^3
Interval 2.411 to 9.216
|
3.306 1000*cells/mm^3
Interval 2.981 to 4.061
|
3.621 1000*cells/mm^3
Interval 2.507 to 4.458
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Neutrophils (1000*cells/mm^3)-Day 14
|
3.1235 1000*cells/mm^3
Interval 2.347 to 4.678
|
5.1805 1000*cells/mm^3
Interval 3.959 to 6.402
|
3.224 1000*cells/mm^3
Interval 2.91 to 4.044
|
3.5165 1000*cells/mm^3
Interval 2.4525 to 4.196
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Neutrophils (1000*cells/mm^3)-Day 42
|
3.036 1000*cells/mm^3
Interval 2.671 to 3.917
|
2.292 1000*cells/mm^3
Interval 1.436 to 5.035
|
3.31 1000*cells/mm^3
Interval 3.042 to 4.522
|
3.348 1000*cells/mm^3
Interval 2.4 to 4.1765
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Neutrophils (1000*cells/mm^3)-Day 98
|
3.0915 1000*cells/mm^3
Interval 2.539 to 3.892
|
2.961 1000*cells/mm^3
Interval 2.744 to 5.623
|
2.626 1000*cells/mm^3
Interval 2.158 to 3.859
|
2.9925 1000*cells/mm^3
Interval 2.723 to 3.522
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Neutrophils (1000*cells/mm^3)-Day 175
|
2.7645 1000*cells/mm^3
Interval 2.22 to 3.673
|
2.902 1000*cells/mm^3
Interval 1.742 to 3.688
|
4.694 1000*cells/mm^3
Interval 2.979 to 6.17
|
2.773 1000*cells/mm^3
Interval 2.244 to 3.119
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Neutrophils (1000*cells/mm^3)-Day 182
|
—
|
—
|
—
|
3.018 1000*cells/mm^3
Interval 2.298 to 3.738
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Neutrophils (1000*cells/mm^3)-Day 273
|
3.011 1000*cells/mm^3
Interval 2.346 to 3.859
|
6.428 1000*cells/mm^3
Interval 1.76 to 11.096
|
2.677 1000*cells/mm^3
Interval 1.901 to 2.783
|
3.279 1000*cells/mm^3
Interval 2.654 to 3.81
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Lymphocytes (1000*cells/mm^3)- Screening
|
1.765 1000*cells/mm^3
Interval 1.4 to 2.18
|
1.84 1000*cells/mm^3
Interval 1.2 to 2.757
|
1.928 1000*cells/mm^3
Interval 1.904 to 2.74
|
1.916 1000*cells/mm^3
Interval 1.47 to 2.09
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Lymphocytes (1000*cells/mm^3)-Day 14
|
1.873 1000*cells/mm^3
Interval 1.6115 to 2.3815
|
2.9485 1000*cells/mm^3
Interval 2.3 to 3.597
|
1.712 1000*cells/mm^3
Interval 1.5 to 1.83
|
1.907 1000*cells/mm^3
Interval 1.5705 to 2.269
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Lymphocytes (1000*cells/mm^3)-Day 42
|
1.88 1000*cells/mm^3
Interval 1.51 to 2.26
|
2.35 1000*cells/mm^3
Interval 0.86 to 3.216
|
2.037 1000*cells/mm^3
Interval 1.986 to 2.09
|
1.8925 1000*cells/mm^3
Interval 1.5395 to 2.245
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Lymphocytes (1000*cells/mm^3)-Day 98
|
1.668 1000*cells/mm^3
Interval 1.464 to 2.244
|
2.13 1000*cells/mm^3
Interval 1.07 to 2.744
|
2.15 1000*cells/mm^3
Interval 1.786 to 3.441
|
1.8265 1000*cells/mm^3
Interval 1.503 to 2.211
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Lymphocytes (1000*cells/mm^3)-Day 175
|
1.846 1000*cells/mm^3
Interval 1.472 to 2.14
|
1.42 1000*cells/mm^3
Interval 0.91 to 2.917
|
1.855 1000*cells/mm^3
Interval 1.793 to 3.25
|
1.8365 1000*cells/mm^3
Interval 1.66 to 2.251
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Lymphocytes (1000*cells/mm^3)-Day 182
|
—
|
—
|
—
|
1.847 1000*cells/mm^3
Interval 1.824 to 1.87
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count in 1000*Cells/mm^3
Lymphocytes (1000*cells/mm^3)-Day 273
|
1.701 1000*cells/mm^3
Interval 1.45 to 2.0205
|
1.76 1000*cells/mm^3
Interval 0.89 to 2.63
|
2.328 1000*cells/mm^3
Interval 1.651 to 2.37
|
1.717 1000*cells/mm^3
Interval 1.587 to 2.009
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 42, 98, 175 and 273Population: 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 local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
WBC (1000*cells/mm^3)- Screening
|
6.4 1000*cells/mm^3
Interval 5.2 to 7.5
|
7.9 1000*cells/mm^3
Interval 4.2 to 12.0
|
5.7 1000*cells/mm^3
Interval 5.4 to 7.2
|
6.2 1000*cells/mm^3
Interval 5.0 to 6.7
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
WBC (1000*cells/mm^3)-Day 14
|
5.55 1000*cells/mm^3
Interval 4.85 to 7.45
|
9.75 1000*cells/mm^3
Interval 9.7 to 9.8
|
5.4 1000*cells/mm^3
Interval 5.3 to 6.0
|
6.25 1000*cells/mm^3
Interval 5.3 to 7.05
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
WBC (1000*cells/mm^3)-Day 42
|
6 1000*cells/mm^3
Interval 4.8 to 6.8
|
8.1 1000*cells/mm^3
Interval 2.8 to 8.2
|
5.9 1000*cells/mm^3
Interval 5.5 to 7.0
|
6 1000*cells/mm^3
Interval 4.85 to 7.05
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
WBC (1000*cells/mm^3)-Day 98
|
5.35 1000*cells/mm^3
Interval 4.5 to 6.9
|
7 1000*cells/mm^3
Interval 4.5 to 8.8
|
6.2 1000*cells/mm^3
Interval 4.8 to 6.4
|
5.75 1000*cells/mm^3
Interval 5.0 to 6.3
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
WBC (1000*cells/mm^3)-Day 175
|
5.1 1000*cells/mm^3
Interval 4.5 to 6.8
|
5.9 1000*cells/mm^3
Interval 3.1 to 7.8
|
7.2 1000*cells/mm^3
Interval 5.3 to 10.0
|
5.3 1000*cells/mm^3
Interval 4.9 to 5.9
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
WBC (1000*cells/mm^3)-Day 182
|
—
|
—
|
—
|
5.45 1000*cells/mm^3
Interval 4.9 to 6.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
WBC (1000*cells/mm^3)-Day 273
|
5.55 1000*cells/mm^3
Interval 4.4 to 6.75
|
8.9 1000*cells/mm^3
Interval 3.2 to 14.6
|
4.9 1000*cells/mm^3
Interval 4.8 to 5.6
|
5.9 1000*cells/mm^3
Interval 5.1 to 6.5
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
Platelets (1000*cells/mm^3)- Screening
|
244 1000*cells/mm^3
Interval 198.0 to 294.0
|
274 1000*cells/mm^3
Interval 206.0 to 347.0
|
264 1000*cells/mm^3
Interval 213.0 to 276.0
|
271 1000*cells/mm^3
Interval 236.0 to 305.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
Platelets (1000*cells/mm^3)-Day 14
|
269 1000*cells/mm^3
Interval 241.0 to 330.0
|
335 1000*cells/mm^3
Interval 292.0 to 378.0
|
231 1000*cells/mm^3
Interval 213.0 to 254.0
|
276.5 1000*cells/mm^3
Interval 241.5 to 301.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
Platelets (1000*cells/mm^3)-Day 42
|
260 1000*cells/mm^3
Interval 238.0 to 300.0
|
265 1000*cells/mm^3
Interval 225.0 to 402.0
|
226 1000*cells/mm^3
Interval 226.0 to 239.0
|
261.5 1000*cells/mm^3
Interval 242.5 to 297.5
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
Platelets (1000*cells/mm^3)-Day 98
|
241 1000*cells/mm^3
Interval 207.0 to 306.0
|
302 1000*cells/mm^3
Interval 203.0 to 394.0
|
262 1000*cells/mm^3
Interval 226.0 to 266.0
|
275 1000*cells/mm^3
Interval 255.0 to 292.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
Platelets (1000*cells/mm^3)-Day 175
|
241.5 1000*cells/mm^3
Interval 215.0 to 260.0
|
255 1000*cells/mm^3
Interval 243.0 to 352.0
|
256 1000*cells/mm^3
Interval 224.0 to 269.0
|
271 1000*cells/mm^3
Interval 242.0 to 292.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
Platelets (1000*cells/mm^3)-Day 182
|
—
|
—
|
—
|
255.5 1000*cells/mm^3
Interval 246.0 to 265.0
|
|
Chemistry and Hematology Laboratory Measures - Platelets, WBC in 1000*Cells/mm^3
Platelets (1000*cells/mm^3)-Day 273
|
243.5 1000*cells/mm^3
Interval 217.0 to 279.0
|
229.5 1000*cells/mm^3
Interval 223.0 to 236.0
|
232 1000*cells/mm^3
Interval 219.0 to 263.0
|
284 1000*cells/mm^3
Interval 233.0 to 306.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 42, 98, 182 and 273 for (ALP), (AST), (ALT), (CPK), creatinine. Measured during screening, Days 14, 42, 98, 175, 182 and 273 for Lymphocyte count, Neutrophil count Platelets, WBC, hemoglobin.Population: 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. Visit schedule is not the same for each laboratory measures. For visits not on the schedule, number analyzed is 0 or applicable participants number.
The number (percentage) of participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade \> 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatine phosphokinase (CPK), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by treatment group and visit time
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Alkaline Phosphatase (U/L)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Alkaline Phosphatase (U/L)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Alkaline Phosphatase (U/L)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Alkaline Phosphatase (U/L)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Alkaline Phosphatase (U/L)-Day 273
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Creatinine (g/dL)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Creatinine (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Creatinine (g/dL)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Creatinine (g/dL)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Creatinine (g/dL)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Creatinine (g/dL)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Creatinine (g/dL)-Day 273
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
creatine phosphokinase (U/L)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
creatine phosphokinase (U/L)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
creatine phosphokinase (U/L)-Day 42
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
creatine phosphokinase (U/L)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
creatine phosphokinase (U/L)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
creatine phosphokinase (U/L)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
creatine phosphokinase (U/L)-Day 273
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000*Cells/mm^3)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000*Cells/mm^3)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000*Cells/mm^3)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000*Cells/mm^3)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000*Cells/mm^3)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000*Cells/mm^3)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000*Cells/mm^3)-Day 273
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000*Cells/mm^3)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000*Cells/mm^3)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000*Cells/mm^3)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000*Cells/mm^3)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000*Cells/mm^3)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000*Cells/mm^3)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000*Cells/mm^3)-Day 273
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Hemoglobin (g/dL)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Hemoglobin (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Hemoglobin (g/dL)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Hemoglobin (g/dL)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Hemoglobin (g/dL)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Hemoglobin (g/dL)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Hemoglobin (g/dL)-Day 273
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000*Cells/mm^3)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000*Cells/mm^3)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000*Cells/mm^3)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000*Cells/mm^3)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000*Cells/mm^3)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000*Cells/mm^3)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000*Cells/mm^3)-Day 273
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000*Cells/mm^3)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000*Cells/mm^3)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000*Cells/mm^3)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000*Cells/mm^3)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000*Cells/mm^3)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000*Cells/mm^3)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000*Cells/mm^3)-Day 273
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
ALT (SGPT) (U/L)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
ALT (SGPT) (U/L)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
ALT (SGPT) (U/L)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
ALT (SGPT) (U/L)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
ALT (SGPT) (U/L)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
ALT (SGPT) (U/L)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
ALT (SGPT) (U/L)-Day 273
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)-Day 42
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)-Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)-Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)-Day 182
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)-Day 273
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Alkaline Phosphatase (U/L)- Screening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Alkaline Phosphatase (U/L)-Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through Month 18The number (percentage) of participants with early discontinuation of vaccinations and reason for discontinuation was summarized by arm
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Refused study product administration
|
1 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Clinical event (not reacto, HIV, death)
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Investigator decision
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
EP device difficulty
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Participant Relocated
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Early Discontinuation of Vaccinations and Reason for Discontinuation
Did not discontinue SPA
|
21 Participants
|
3 Participants
|
2 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: Measured during Day 0, 28, 84 and 168Population: One participant in Group 1 had VASOVAGAL REACTION AND SEIZURE on enrollment visit. One participant in Group 2 experienced EP device difficulty on enrollment visit. These two participants had no Visual Analog Scale - Pain Assessment Scores.
A visual analog scale is a horizontal line, 10 cm in length, anchored by word descriptors at each end ("no pain" and "worst pain"). The visual analog scale score is determined by measuring in centimeters from the left hand end of the line to the point that the patient marks, 0 cm being no pain and 10 cm being maximum pain.The pain assessment scores for each arm at each vaccination visit were summarized with visual analog scale (VAS)
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
0 - V2.0 - Day 0
|
4.75 Score
Interval 1.9 to 6.4
|
6.9 Score
Interval 4.4 to 7.9
|
4.9 Score
Interval 0.6 to 8.4
|
4.65 Score
Interval 2.1 to 7.05
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
5-7 - V2.0 - Day 0
|
0.85 Score
Interval 0.2 to 2.05
|
2.2 Score
Interval 0.5 to 4.7
|
1.7 Score
Interval 0.3 to 1.8
|
0.8 Score
Interval 0.0 to 1.95
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
25_60 - V2.0 - Day 0
|
0.7 Score
Interval 0.1 to 1.1
|
1.7 Score
Interval 0.3 to 2.1
|
0.7 Score
Interval 0.3 to 1.8
|
0.45 Score
Interval 0.0 to 1.4
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
0 - V4.0 - Day 28
|
3.65 Score
Interval 1.4 to 5.5
|
5.5 Score
Interval 3.7 to 6.4
|
3.3 Score
Interval 3.1 to 3.5
|
4.3 Score
Interval 3.2 to 6.9
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
5-7 - V4.0 - Day 28
|
0.7 Score
Interval 0.2 to 2.2
|
2.4 Score
Interval 1.8 to 4.2
|
1.05 Score
Interval 1.0 to 1.1
|
1.6 Score
Interval 0.9 to 2.8
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
25_60 - V4.0 - Day 28
|
0.5 Score
Interval 0.2 to 1.4
|
1.8 Score
Interval 1.0 to 3.6
|
0.65 Score
Interval 0.3 to 1.0
|
0.5 Score
Interval 0.3 to 1.2
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
0 - V7.0 - Day 84
|
3.6 Score
Interval 1.8 to 4.9
|
6.85 Score
Interval 4.4 to 9.3
|
5 Score
Interval 2.2 to 7.8
|
3.95 Score
Interval 3.1 to 6.9
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
5-7 - V7.0 - Day 84
|
0.8 Score
Interval 0.2 to 1.2
|
1.7 Score
Interval 1.6 to 1.8
|
2.15 Score
Interval 0.4 to 3.9
|
1.1 Score
Interval 0.2 to 1.8
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
25_60 - V7.0 - Day 84
|
0.3 Score
Interval 0.0 to 0.9
|
1.1 Score
Interval 1.0 to 1.2
|
1.9 Score
Interval 0.2 to 3.6
|
0.55 Score
Interval 0.1 to 0.9
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
0 - V9.0 - Day 168
|
3.95 Score
Interval 0.4 to 5.75
|
3.4 Score
Interval 3.4 to 3.4
|
2.6 Score
Interval 0.7 to 4.5
|
5.1 Score
Interval 1.5 to 6.8
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
5-7 - V9.0 - Day 168
|
0.6 Score
Interval 0.1 to 2.0
|
2.4 Score
Interval 2.4 to 2.4
|
0.75 Score
Interval 0.5 to 1.0
|
0.8 Score
Interval 0.1 to 1.6
|
|
Magnitude of Local Injection/EP Site Pain as Measured by a Visual Analog Scale (Day 0, Day 28, Day 84, Day 168)
25_60 - V9.0 - Day 168
|
0.3 Score
Interval 0.0 to 1.0
|
0.8 Score
Interval 0.8 to 0.8
|
0.3 Score
Interval 0.2 to 0.4
|
0.2 Score
Interval 0.1 to 0.5
|
PRIMARY outcome
Timeframe: Measured during Visit 3 (Day14), Visit 5 (Day 35), Visit 8 (Day 98), Visit 10 (Day 175)Population: One participant in Group 1 had VASOVAGAL REACTION AND SEIZURE on enrollment. One participant in Group 2 had an interim visit done as the visit was done prior to the visit 3.0 window opening. Data Manager instructed site to complete the interim visit and then following w/ a missed visit. These two cases were missed in the enrollment visit.
Distribution of responses to questions regarding acceptability of study injection procedures \[ Visits 3, 5, 8, 10\] were summarized by category (Acceptable/Unacceptable/Don?t know/ Don?t Remember)
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Acceptable- Day 14
|
20 Participants
|
3 Participants
|
2 Participants
|
17 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Unacceptable- Day 14
|
2 Participants
|
0 Participants
|
1 Participants
|
7 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Don't Know/Don't Remember- Day 14
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Acceptable- Day 175
|
19 Participants
|
3 Participants
|
2 Participants
|
16 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Unacceptable- Day 175
|
2 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Don't Know/Don't Remember- Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Acceptable- Day 35
|
20 Participants
|
3 Participants
|
2 Participants
|
20 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Unacceptable- Day 35
|
2 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Don't Know/Don't Remember- Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Acceptable- Day 98
|
18 Participants
|
3 Participants
|
2 Participants
|
19 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Unacceptable- Day 98
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-1- Don't Know/Don't Remember- Day 98
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Acceptable- Day 14
|
23 Participants
|
3 Participants
|
3 Participants
|
22 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Unacceptable- Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Don't Know/Don't Remember- Day 14
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Acceptable- Day 175
|
21 Participants
|
3 Participants
|
2 Participants
|
17 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Unacceptable- Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Don't Know/Don't Remember- Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Acceptable- Day 35
|
20 Participants
|
3 Participants
|
2 Participants
|
22 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Unacceptable- Day 35
|
2 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Don't Know/Don't Remember- Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Acceptable- Day 98
|
21 Participants
|
3 Participants
|
2 Participants
|
20 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Unacceptable- Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-2- Don't Know/Don't Remember- Day 98
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Acceptable- Day 14
|
21 Participants
|
2 Participants
|
3 Participants
|
19 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Unacceptable- Day 14
|
2 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Don't Know/Don't Remember- Day 14
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Acceptable- Day 175
|
18 Participants
|
1 Participants
|
2 Participants
|
15 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Unacceptable- Day 175
|
3 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Don't Know/Don't Remember- Day 175
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Acceptable- Day 35
|
19 Participants
|
3 Participants
|
2 Participants
|
18 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Unacceptable- Day 35
|
3 Participants
|
0 Participants
|
0 Participants
|
5 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Don't Know/Don't Remember- Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Acceptable- Day 98
|
19 Participants
|
2 Participants
|
2 Participants
|
20 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Unacceptable- Day 98
|
3 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-3- Don't Know/Don't Remember- Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Acceptable- Day 14
|
24 Participants
|
3 Participants
|
3 Participants
|
24 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Unacceptable- Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Don't Know/Don't Remember- Day 14
|
1 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- No Other Side Effects- Day 14
|
15 Participants
|
2 Participants
|
3 Participants
|
20 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Don't Know/Don't Remember- Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Acceptable- Day 175
|
20 Participants
|
3 Participants
|
2 Participants
|
18 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Unacceptable- Day 175
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Don't Know/Don't Remember- Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Acceptable- Day 35
|
20 Participants
|
2 Participants
|
2 Participants
|
23 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Unacceptable- Day 35
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Don't Know/Don't Remember- Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Acceptable- Day 98
|
21 Participants
|
3 Participants
|
2 Participants
|
22 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Unacceptable- Day 98
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-4- Don't Know/Don't Remember- Day 98
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Acceptable- Day 14
|
8 Participants
|
0 Participants
|
0 Participants
|
4 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Unacceptable- Day 14
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Acceptable- Day 175
|
1 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Unacceptable- Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Don't Know/Don't Remember- Day 175
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- No Other Side Effects- Day 175
|
20 Participants
|
3 Participants
|
1 Participants
|
15 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Acceptable- Day 35
|
5 Participants
|
1 Participants
|
0 Participants
|
4 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Unacceptable- Day 35
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Don't Know/Don't Remember- Day 35
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- No Other Side Effects- Day 35
|
15 Participants
|
2 Participants
|
2 Participants
|
19 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Acceptable- Day 98
|
4 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Unacceptable- Day 98
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- Don't Know/Don't Remember- Day 98
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Distribution of Responses to Questions Regarding Acceptability of Study Injection Procedures [ Visits 3, 5, 8, 10]
Question-5- No Other Side Effects- Day 98
|
16 Participants
|
3 Participants
|
2 Participants
|
20 Participants
|
PRIMARY outcome
Timeframe: M1.5 and M6.5Population: Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan.
For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools and the total number of positive responses was defined as the breadth.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=24 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - M1.5
|
0.333 Number of targeted CEs
Interval 0.141 to 0.699
|
—
|
—
|
0.261 Number of targeted CEs
Interval 0.096 to 0.591
|
|
Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - M6.5
|
0.217 Number of targeted CEs
Interval 0.075 to 0.487
|
—
|
—
|
0.682 Number of targeted CEs
Interval 0.375 to 1.159
|
|
Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - M1.5
|
0.25 Number of targeted CEs
Negative binomial regression failed to estimated the variance due to over-dispersion parameter when applied.
|
—
|
—
|
0.042 Number of targeted CEs
Negative binomial regression failed to estimated the variance due to over-dispersion parameter when applied.
|
|
Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - M6.5
|
0.304 Number of targeted CEs
Interval 0.125 to 0.634
|
—
|
—
|
0.455 Number of targeted CEs
Interval 0.215 to 0.87
|
|
Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - Overall - M1.5
|
0.583 Number of targeted CEs
Interval 0.295 to 1.109
|
—
|
—
|
0.304 Number of targeted CEs
Interval 0.12 to 0.672
|
|
Summary of T-Cell Epitope Mapping Breadth (Defined as the Number of Targeted CEs) Among All Participants by T-cell Subset (CD4+, CD8+), Visit, and Treatment Arm [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - Overall - M6.5
|
0.522 Number of targeted CEs
Interval 0.267 to 0.936
|
—
|
—
|
1.136 Number of targeted CEs
Interval 0.697 to 1.801
|
SECONDARY outcome
Timeframe: M0, M1.5 and M6.5Population: Immunogenicity Population
Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=6 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 1.5
|
7 Participants
|
0 Participants
|
—
|
8 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 6.5
|
9 Participants
|
0 Participants
|
—
|
15 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5
|
22 Participants
|
0 Participants
|
—
|
9 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5
|
21 Participants
|
0 Participants
|
—
|
20 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5
|
8 Participants
|
0 Participants
|
—
|
7 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5
|
8 Participants
|
0 Participants
|
—
|
14 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5
|
22 Participants
|
0 Participants
|
—
|
7 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5
|
19 Participants
|
0 Participants
|
—
|
20 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5
|
5 Participants
|
0 Participants
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5
|
5 Participants
|
0 Participants
|
—
|
9 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5
|
9 Participants
|
0 Participants
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5
|
16 Participants
|
0 Participants
|
—
|
5 Participants
|
SECONDARY outcome
Timeframe: M0, M1.5 and M6.5Population: Immunogenicity Population
Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Athe Mixture Models for Single-cell Assays (MIMOSA) statistical framework was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=6 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 1.5
|
8 Participants
|
0 Participants
|
—
|
8 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 6.5
|
11 Participants
|
0 Participants
|
—
|
16 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5
|
22 Participants
|
0 Participants
|
—
|
9 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5
|
22 Participants
|
0 Participants
|
—
|
20 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5
|
8 Participants
|
0 Participants
|
—
|
7 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5
|
9 Participants
|
0 Participants
|
—
|
14 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5
|
22 Participants
|
0 Participants
|
—
|
8 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5
|
19 Participants
|
0 Participants
|
—
|
20 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5
|
5 Participants
|
0 Participants
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5
|
5 Participants
|
0 Participants
|
—
|
9 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0
|
0 Participants
|
0 Participants
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5
|
10 Participants
|
0 Participants
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell MIMOSA Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5
|
18 Participants
|
0 Participants
|
—
|
5 Participants
|
SECONDARY outcome
Timeframe: M0, M1.5 and M6.5Population: Immunogenicity Population
Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. Percentage of CD4+ T cells expressing CD40L+ was used as the magnititudes response for ICS assay.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=6 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=25 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 0
|
0 percentage
Interval 0.0 to 0.0
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 1.5
|
0 percentage
Interval 0.0 to 0.1
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.1
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - Gag CE Total - at Month 6.5
|
0 percentage
Interval 0.0 to 0.1
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0.1 percentage
Interval 0.1 to 0.2
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 0
|
0 percentage
Interval 0.0 to 0.0
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 1.5
|
0.3 percentage
Interval 0.2 to 0.3
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.1
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
CD40L+ - CD4+ - HBX2 p55 Gag - at Month 6.5
|
0.3 percentage
Interval 0.2 to 0.4
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0.2 percentage
Interval 0.1 to 0.4
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 0
|
0 percentage
Interval 0.0 to 0.0
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 1.5
|
0 percentage
Interval 0.0 to 0.1
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.1
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - Gag CE Total - at Month 6.5
|
0 percentage
Interval 0.0 to 0.1
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0.1 percentage
Interval 0.0 to 0.1
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 0
|
0 percentage
Interval 0.0 to 0.0
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 1.5
|
0.3 percentage
Interval 0.2 to 0.4
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.1
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD4+ - HBX2 p55 Gag - at Month 6.5
|
0.3 percentage
Interval 0.2 to 0.4
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0.2 percentage
Interval 0.1 to 0.3
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 0
|
0 percentage
Interval 0.0 to 0.0
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 1.5
|
0 percentage
Interval 0.0 to 0.0
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - Gag CE Total - at Month 6.5
|
0 percentage
Interval 0.0 to 0.0
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.2
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 0
|
0 percentage
Interval 0.0 to 0.0
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 1.5
|
0.1 percentage
Interval 0.0 to 0.2
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes Among All Participants by Cytokine, T-Cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M0, M1.5 and M6.5]
IFNg/IL2 - CD8+ - HBX2 p55 Gag - at Month 6.5
|
0.1 percentage
Interval 0.1 to 0.5
|
0 percentage
Interval 0.0 to 0.0
|
—
|
0 percentage
Interval 0.0 to 0.0
|
SECONDARY outcome
Timeframe: M0, M1.5 and M6.5Population: Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan.
Flow cytometry was used to examine HIV-1 specific CD4+ and CD8+ T-cell responses using a validated ICS assay. A one sided Fisher's exact test was applied to detective the positivity response. If at least one peptide pool for a specific HIV-1 protein was positive, then the overall response to the protein was considered positive. If any peptide pool was positive for a T-cellubset, then the overall response for that T-cell subset was considered positive.
Outcome measures
| Measure |
Group 2: Vaccine
n=25 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=24 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 1 - M1.5
|
4 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 1 - M6.5
|
2 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 2 - M1.5
|
0 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 2 - M6.5
|
0 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 3 - M1.5
|
0 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 3 - M6.5
|
0 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 4 - M1.5
|
0 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 4 - M6.5
|
0 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 5 - M1.5
|
1 Participants
|
—
|
—
|
3 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 5 - M6.5
|
0 Participants
|
—
|
—
|
6 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 6 - M1.5
|
3 Participants
|
—
|
—
|
2 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 6 - M6.5
|
3 Participants
|
—
|
—
|
6 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 7 - M1.5
|
0 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 7 - M6.5
|
0 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p15 - M1.5
|
9 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p15 - M6.5
|
9 Participants
|
—
|
—
|
3 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p17 - M1.5
|
18 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p17 - M6.5
|
14 Participants
|
—
|
—
|
6 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p24 - M1.5
|
18 Participants
|
—
|
—
|
6 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p24 - M6.5
|
14 Participants
|
—
|
—
|
17 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 1 - M1.5
|
0 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 1 - M6.5
|
0 Participants
|
—
|
—
|
2 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 2 - M1.5
|
1 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 2 - M6.5
|
0 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 3 - M1.5
|
3 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 3 - M6.5
|
2 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 4 - M1.5
|
2 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 4 - M6.5
|
3 Participants
|
—
|
—
|
3 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 5 - M1.5
|
1 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 5 - M6.5
|
1 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 6 - M1.5
|
1 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 6 - M6.5
|
1 Participants
|
—
|
—
|
2 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 7 - M1.5
|
0 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 7 - M6.5
|
0 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p15 - M1.5
|
3 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p15 - M6.5
|
3 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p17 - M1.5
|
2 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p17 - M6.5
|
3 Participants
|
—
|
—
|
0 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p24 - M1.5
|
4 Participants
|
—
|
—
|
1 Participants
|
|
CD4+ and CD8+ T Cell Response Rate Measured by Flow Cytometry to p24CE and HIV Gag by Cytokine, T-cell Subset (CD4+, CD8+), Antigen and Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p24 - M6.5
|
7 Participants
|
—
|
—
|
7 Participants
|
SECONDARY outcome
Timeframe: M1.5 and M6.5Population: Immunogenicity Population. Group 3 and Group 4 are control groups. Control groups were excluded in this analysis because that no peptide responses were expected in control groups. This is pre-specified in Study Analysis Plan.
For participants with a positive Fisher's Exact response to Gag CE Total and/or HBX2 p55Gag for either IFN-γ and/or IL2(CD4+ or CD8+) or for CD40L(CD4+)at month1.5and/or month 6.5, samples were further assayed against the seven individual CE peptide pools. Percentage of CD8+ T cells expressing IFN-gamma was used as the magnitude response. The background-substracted magnitude was summarized by treatment group. The negative reading of magnitude is due to background substracted.
Outcome measures
| Measure |
Group 2: Vaccine
n=24 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=22 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 4 - M1.5
|
0 percentage
Interval -0.002 to 0.012
|
—
|
—
|
0 percentage
Interval -0.003 to 0.012
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 4 - M6.5
|
0 percentage
Interval -0.001 to 0.002
|
—
|
—
|
0 percentage
Interval -0.003 to 0.005
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p24 - M6.5
|
0.053 percentage
Interval 0.035 to 0.098
|
—
|
—
|
0.08 percentage
Interval 0.051 to 0.119
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 1 - M1.5
|
0 percentage
Interval -0.003 to 0.005
|
—
|
—
|
0 percentage
Interval 0.0 to 0.011
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 1 - M6.5
|
-0.001 percentage
Interval -0.003 to 0.0
|
—
|
—
|
-0.002 percentage
Interval -0.003 to 0.007
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 2 - M1.5
|
0 percentage
Interval -0.003 to 0.008
|
—
|
—
|
0 percentage
Interval 0.0 to 0.004
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 2 - M6.5
|
0 percentage
Interval -0.003 to 0.004
|
—
|
—
|
-0.003 percentage
Interval -0.004 to 0.004
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 3 - M1.5
|
0 percentage
Interval -0.004 to 0.006
|
—
|
—
|
0 percentage
Interval -0.002 to 0.007
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 3 - M6.5
|
0 percentage
Interval -0.002 to 0.003
|
—
|
—
|
0 percentage
Interval -0.005 to 0.002
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 5 - M1.5
|
0 percentage
Interval -0.002 to 0.007
|
—
|
—
|
0 percentage
Interval -0.004 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 5 - M6.5
|
0.002 percentage
Interval -0.003 to 0.008
|
—
|
—
|
0 percentage
Interval -0.005 to 0.001
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 6 - M1.5
|
0 percentage
Interval -0.003 to 0.004
|
—
|
—
|
0 percentage
Interval -0.004 to 0.005
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 6 - M6.5
|
0 percentage
Interval -0.002 to 0.002
|
—
|
—
|
0.001 percentage
Interval -0.004 to 0.008
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 7 - M1.5
|
0 percentage
Interval -0.002 to 0.005
|
—
|
—
|
-0.002 percentage
Interval -0.003 to 0.001
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag CE 7 - M6.5
|
0 percentage
Interval -0.003 to 0.003
|
—
|
—
|
-0.003 percentage
Interval -0.007 to 0.0
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p15 - M1.5
|
0 percentage
Interval -0.002 to 0.012
|
—
|
—
|
0 percentage
Interval -0.004 to 0.008
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p15 - M6.5
|
0.002 percentage
Interval -0.002 to 0.016
|
—
|
—
|
-0.001 percentage
Interval -0.005 to 0.003
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p17 - M1.5
|
0.007 percentage
Interval 0.001 to 0.022
|
—
|
—
|
0 percentage
Interval -0.006 to 0.004
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p17 - M6.5
|
0.007 percentage
Interval 0.002 to 0.022
|
—
|
—
|
0 percentage
Interval -0.006 to 0.005
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p24 - M1.5
|
0.01 percentage
Interval 0.0 to 0.058
|
—
|
—
|
0.007 percentage
Interval 0.006 to 0.018
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD8+ - Gag p24 - M6.5
|
0.016 percentage
Interval 0.001 to 0.109
|
—
|
—
|
0.005 percentage
Interval -0.001 to 0.061
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 2 - M6.5
|
0.002 percentage
Interval -0.003 to 0.005
|
—
|
—
|
-0.001 percentage
Interval -0.004 to 0.01
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p24 - M1.5
|
0.054 percentage
Interval 0.04 to 0.08
|
—
|
—
|
0.055 percentage
Interval 0.03 to 0.061
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 2 - M1.5
|
0.001 percentage
Interval -0.003 to 0.004
|
—
|
—
|
0 percentage
Interval -0.003 to 0.002
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 3 - M1.5
|
0 percentage
Interval -0.002 to 0.003
|
—
|
—
|
0 percentage
Interval -0.003 to 0.007
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 3 - M6.5
|
-0.001 percentage
Interval -0.004 to 0.004
|
—
|
—
|
-0.001 percentage
Interval -0.004 to 0.007
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 4 - M1.5
|
0.002 percentage
Interval -0.001 to 0.005
|
—
|
—
|
0.001 percentage
Interval 0.0 to 0.007
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 4 - M6.5
|
0.001 percentage
Interval -0.002 to 0.007
|
—
|
—
|
0.002 percentage
Interval -0.004 to 0.005
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 5 - M1.5
|
0.005 percentage
Interval 0.002 to 0.01
|
—
|
—
|
0.034 percentage
Interval 0.017 to 0.043
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 5 - M6.5
|
0.002 percentage
Interval -0.002 to 0.008
|
—
|
—
|
0.022 percentage
Interval 0.015 to 0.035
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 6 - M1.5
|
0.012 percentage
Interval 0.002 to 0.02
|
—
|
—
|
0.008 percentage
Interval 0.0 to 0.024
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 6 - M6.5
|
0.004 percentage
Interval 0.001 to 0.016
|
—
|
—
|
0.02 percentage
Interval 0.005 to 0.039
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 7 - M1.5
|
-0.001 percentage
Interval -0.005 to 0.002
|
—
|
—
|
-0.001 percentage
Interval -0.004 to 0.001
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 7 - M6.5
|
-0.003 percentage
Interval -0.005 to 0.001
|
—
|
—
|
0.001 percentage
Interval -0.001 to 0.003
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p15 - M1.5
|
0.028 percentage
Interval 0.011 to 0.052
|
—
|
—
|
-0.002 percentage
Interval -0.002 to 0.001
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p15 - M6.5
|
0.026 percentage
Interval 0.009 to 0.079
|
—
|
—
|
0.013 percentage
Interval 0.005 to 0.023
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p17 - M1.5
|
0.07 percentage
Interval 0.048 to 0.098
|
—
|
—
|
0 percentage
Interval -0.004 to 0.003
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag p17 - M6.5
|
0.066 percentage
Interval 0.032 to 0.116
|
—
|
—
|
0.03 percentage
Interval 0.016 to 0.062
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 1 - M1.5
|
0.002 percentage
Interval -0.002 to 0.007
|
—
|
—
|
-0.003 percentage
Interval -0.004 to -0.001
|
|
Summary of CD4+ and CD8+ T Cell Response Magnitudes to Epitope Mapping Gag Among All Participants by by Cytokine, T-Cell Subset (CD4+, CD8+), Antigenand Treatment Group [Time Frame: Measured at M1.5 and M6.5]
IFNg+ - CD4+ - Gag CE 1 - M6.5
|
0.003 percentage
Interval -0.003 to 0.007
|
—
|
—
|
-0.002 percentage
Interval -0.005 to 0.002
|
SECONDARY outcome
Timeframe: M6.5Population: Immunogenicity Population
The frequency of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA).Samples from post-enrollment visits were declared to have positive responses if they met three conditions: (1) the MFI minus blank (MFI\*) values were ≥ antigen-specific cutoff at the 1:50 dilution level (based on the 95th percentile of baseline samples as calculated by SAS PROC UNIVARIATE default method, and at least 100 MFI minus blank), (2) the MFI minus blank values were greater than 3 times the baseline (day 0) MFI minus blank values, and (3) the MFI values were greater than 3 times the baseline MFI values.
Outcome measures
| Measure |
Group 2: Vaccine
n=20 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=4 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=22 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Binding Antibody IgG Responses Rate by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5]
|
16 Participants
|
0 Participants
|
—
|
20 Participants
|
SECONDARY outcome
Timeframe: M6.5Population: Immunogenicity Population
The magnitude of IgG binding antibody responses were measured by the HIV-1 binding antibody multiplex assay (BAMA). Serum HIV-1-specific IgG antibody responses are measured at the 1:50 dilution against the p24gag antigen on all available samples .The a background-subtracted mean fluorescent intensity (MFI) at the 1:50 dilution were used to summarize the magnitudes at a given time-point. MFI will be used to determine the positivity of samples. Samples from post-enrollment visits are declared to have positive responses if they meet three conditions: (1) the MFI\* values are greater than the antigen-specific cutoff (based on the 95th percentile of the baseline visit serum samples and at least 100 MFI), (2) the MFI\* values are greater than 3 times the baseline (day 0) MFI\* values, and (3) the MFI values are greater than 3 times the baseline MFI values. The values in Groups 1 and 2 are correct as currently reported.
Outcome measures
| Measure |
Group 2: Vaccine
n=20 Participants
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=4 Participants
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
Placebo: Sodium Chloride, USP 0.9%
|
Group 1: Vaccine
n=22 Participants
P24CE1/2(CE/CE) + gag vaccines
|
|---|---|---|---|---|
|
Binding Antibody IgG Responses Magnitudes by the HIV-1 Binding Antibody Multiplex Assay (BAMA) by Treatment Arm [Time Frame: M6.5]
|
22000 adjusted Mean fluorescent intensity (MFI
Interval 22000.0 to 22000.0
|
1042.1 adjusted Mean fluorescent intensity (MFI
Interval 700.4 to 1470.9
|
—
|
22000 adjusted Mean fluorescent intensity (MFI
Interval 22000.0 to 22000.0
|
Adverse Events
Group 1: Vaccine
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Group 2: Vaccine
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Group 3: Control 1
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 4: Control 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1: Vaccine
n=25 participants at risk
P24CE1/2(CE/CE) + gag vaccines
|
Group 2: Vaccine
n=25 participants at risk
P55gag (gag/gag) vaccines
|
Group 3: Control 1
n=3 participants at risk
Placebo: Sodium Chloride, USP 0.9%
|
Group 4: Control 2
n=3 participants at risk
Placebo: Sodium Chloride, USP 0.9%
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Any Event in SOC
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Blood and lymphatic system disorders
Neutropenia
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Any Event in SOC
|
8.0%
2/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Diarrhoea
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Dyspepsia
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Haemorrhoidal haemorrhage
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
General disorders
Any Event in SOC
|
8.0%
2/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
8.0%
2/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
General disorders
Chest pain
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
General disorders
Complication of device removal
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
General disorders
Influenza like illness
|
4.0%
1/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
General disorders
Pain
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Any Event in SOC
|
24.0%
6/25 • Number of events 9 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
32.0%
8/25 • Number of events 11 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Bronchitis
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Influenza
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Nasopharyngitis
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Tinea pedis
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Upper respiratory tract infection
|
20.0%
5/25 • Number of events 7 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
16.0%
4/25 • Number of events 6 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Viral infection
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
8.0%
2/25 • Number of events 4 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
12.0%
3/25 • Number of events 4 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
66.7%
2/3 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Concussion
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
8.0%
2/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Any Event in SOC
|
16.0%
4/25 • Number of events 8 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
20.0%
5/25 • Number of events 6 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Alanine aminotransferase increased
|
4.0%
1/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Aspartate aminotransferase increased
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Blood creatine phosphokinase increased
|
8.0%
2/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
12.0%
3/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Blood pressure increased
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
8.0%
2/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Investigations
Haemoglobin decreased
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
16.0%
4/25 • Number of events 6 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oral papilloma
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Any Event in SOC
|
16.0%
4/25 • Number of events 6 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
8.0%
2/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Carpal tunnel syndrome
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Dizziness
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Headache
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Presyncope
|
8.0%
2/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Psychomotor hyperactivity
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Seizure
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Nervous system disorders
Syncope
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Psychiatric disorders
Any Event in SOC
|
12.0%
3/25 • Number of events 5 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Psychiatric disorders
Anxiety
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Psychiatric disorders
Depression
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Psychiatric disorders
Insomnia
|
8.0%
2/25 • Number of events 4 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Renal and urinary disorders
Any Event in SOC
|
8.0%
2/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
12.0%
3/25 • Number of events 4 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Renal and urinary disorders
Haematuria
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Renal and urinary disorders
Proteinuria
|
8.0%
2/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
12.0%
3/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Reproductive system and breast disorders
Any Event in SOC
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Reproductive system and breast disorders
Cervical dysplasia
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
33.3%
1/3 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Reproductive system and breast disorders
Premenstrual dysphoric disorder
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Reproductive system and breast disorders
Vaginal discharge
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
12.0%
3/25 • Number of events 3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
8.0%
2/25 • Number of events 2 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
1/25 • Number of events 1 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/25 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
0.00%
0/3 • Measured through Month 12
Number of Participants Reporting Adverse Events (AEs)
|
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