Trial Outcomes & Findings for Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults (NCT NCT02797171)
NCT ID: NCT02797171
Last Updated: 2024-03-20
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
80 participants
Primary outcome timeframe
Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)
Results posted on
2024-03-20
Participant Flow
Participant milestones
| Measure |
Group 1: Vaccine
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
23
|
7
|
16
|
10
|
1
|
|
Overall Study
Safety Population
|
23
|
23
|
7
|
16
|
10
|
1
|
|
Overall Study
COMPLETED
|
19
|
21
|
5
|
15
|
8
|
0
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
2
|
1
|
2
|
1
|
Reasons for withdrawal
| Measure |
Group 1: Vaccine
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
2
|
0
|
2
|
1
|
2
|
0
|
|
Overall Study
Withdrawal by Subject
|
1
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Protocol Violation
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Participant unable to adhere
|
0
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Not Randomized
|
0
|
0
|
0
|
0
|
0
|
1
|
Baseline Characteristics
Evaluating the Safety, Pharmacokinetics, and Anti-Viral Activity of VRC01 and VRC01LS in the Serum and Mucosa of Healthy, HIV-Uninfected Adults
Baseline characteristics by cohort
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 Participants
Biopsy collected but was not randomized to any treatment group
|
Total
n=80 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
31 years
n=5 Participants
|
27 years
n=7 Participants
|
33 years
n=5 Participants
|
30 years
n=4 Participants
|
30 years
n=21 Participants
|
34 years
n=10 Participants
|
29 years
n=115 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Customized
18 - 20 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Age, Customized
21 - 30 years
|
11 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
42 Participants
n=115 Participants
|
|
Age, Customized
31 - 40 years
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
7 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
27 Participants
n=115 Participants
|
|
Age, Customized
41 - 50 years
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
9 Participants
n=115 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
6 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
43 Participants
n=115 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
37 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
22 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
79 Participants
n=115 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 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
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
2 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
0 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
35 Participants
n=115 Participants
|
|
Race (NIH/OMB)
White
|
9 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
8 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
36 Participants
n=115 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
6 Participants
n=115 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
1 Participants
n=115 Participants
|
|
Region of Enrollment
USA
|
13 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
16 Participants
n=4 Participants
|
10 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
54 Participants
n=115 Participants
|
|
Region of Enrollment
South Africa
|
10 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
26 Participants
n=115 Participants
|
PRIMARY outcome
Timeframe: Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Mild
|
4 Participants
|
5 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · None
|
22 Participants
|
23 Participants
|
7 Participants
|
16 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · None
|
19 Participants
|
18 Participants
|
7 Participants
|
15 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · None
|
19 Participants
|
16 Participants
|
7 Participants
|
13 Participants
|
9 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Mild
|
4 Participants
|
6 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · None
|
18 Participants
|
15 Participants
|
7 Participants
|
13 Participants
|
9 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Mild
|
5 Participants
|
7 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Pain and/or Tenderness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · None
|
22 Participants
|
21 Participants
|
7 Participants
|
16 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema/Redness · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Induration/Swelling · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · None
|
22 Participants
|
21 Participants
|
7 Participants
|
16 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Mild
|
0 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms
Erythema and/or Induration · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured through 3 days after each infusion at months 0, 2, 3, 4 or 6 (infusion visits depending on which group participants are in)Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[March 2017\] The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
7 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
13 Participants
|
17 Participants
|
7 Participants
|
15 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
14 Participants
|
18 Participants
|
6 Participants
|
12 Participants
|
9 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
2 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
21 Participants
|
19 Participants
|
7 Participants
|
15 Participants
|
9 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
2 Participants
|
4 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 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
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
9 Participants
|
4 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 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
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
20 Participants
|
19 Participants
|
5 Participants
|
14 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · None
|
22 Participants
|
22 Participants
|
5 Participants
|
16 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Mild
|
1 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Vomiting · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
21 Participants
|
23 Participants
|
7 Participants
|
16 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
22 Participants
|
22 Participants
|
7 Participants
|
15 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
0 Participants
|
0 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
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Diarrhea · None
|
20 Participants
|
17 Participants
|
7 Participants
|
15 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Diarrhea · Mild
|
2 Participants
|
6 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Diarrhea · Moderate
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Diarrhea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Diarrhea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
10 Participants
|
14 Participants
|
3 Participants
|
11 Participants
|
8 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
11 Participants
|
7 Participants
|
3 Participants
|
4 Participants
|
2 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
2 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
21 Participants
|
22 Participants
|
7 Participants
|
16 Participants
|
10 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
2 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
0 Participants
|
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
|
0 Participants
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
alkaline phosphate (ALP) (U/L), aspartate aminotransferase (AST) (U/L), alanine aminotransferase (ALT) (U/L) (Doesn't mention about lab grade \> 1 )
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 Participants
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Screening
|
16 U/L
Interval 13.0 to 22.0
|
16 U/L
Interval 12.0 to 22.0
|
17 U/L
Interval 12.0 to 25.0
|
15.5 U/L
Interval 12.0 to 21.0
|
13 U/L
Interval 9.0 to 15.0
|
33 U/L
Interval 33.0 to 33.0
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Day 1 - 15
|
15 U/L
Interval 12.0 to 23.0
|
15 U/L
Interval 11.0 to 20.0
|
21 U/L
Interval 15.0 to 22.0
|
13 U/L
Interval 10.5 to 19.5
|
13.5 U/L
Interval 10.0 to 26.0
|
—
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Day 57 - 71
|
15 U/L
Interval 11.0 to 20.0
|
16 U/L
Interval 15.0 to 19.0
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Day 99 - 113
|
—
|
—
|
22 U/L
Interval 14.0 to 37.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Day 127 - 141
|
15.5 U/L
Interval 11.5 to 20.5
|
18.5 U/L
Interval 13.5 to 23.0
|
—
|
13 U/L
Interval 9.0 to 16.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Day 169 - 183
|
16 U/L
Interval 12.5 to 20.0
|
15.5 U/L
Interval 11.0 to 18.5
|
17 U/L
Interval 13.0 to 26.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Day 252 - 267
|
15.5 U/L
Interval 13.0 to 22.5
|
19 U/L
Interval 13.0 to 23.0
|
25 U/L
Interval 25.0 to 25.0
|
—
|
18.5 U/L
Interval 13.5 to 37.0
|
—
|
|
Chemistry and Hematology Laboratory Measures
ALT (SGPT) (U/L)- Day 442 - 456
|
—
|
—
|
19 U/L
Interval 11.0 to 57.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
AST (U/L)- Screening
|
20 U/L
Interval 17.0 to 22.0
|
20 U/L
Interval 18.0 to 23.0
|
22 U/L
Interval 17.0 to 27.0
|
19 U/L
Interval 16.5 to 21.0
|
15.5 U/L
Interval 13.0 to 19.0
|
32 U/L
Interval 32.0 to 32.0
|
|
Chemistry and Hematology Laboratory Measures
AST (U/L)- Day 1 - 15
|
19 U/L
Interval 17.0 to 22.0
|
20 U/L
Interval 18.0 to 23.0
|
22 U/L
Interval 18.0 to 37.0
|
18 U/L
Interval 16.0 to 21.0
|
19.5 U/L
Interval 15.0 to 30.0
|
—
|
|
Chemistry and Hematology Laboratory Measures
AST (U/L)- Day 57 - 71
|
18 U/L
Interval 17.0 to 22.0
|
19 U/L
Interval 17.0 to 24.0
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
AST (U/L)- Day 99 - 113
|
—
|
—
|
25 U/L
Interval 16.0 to 40.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
AST (U/L)- Day 127 - 141
|
19.5 U/L
Interval 16.5 to 23.0
|
21 U/L
Interval 17.0 to 25.0
|
—
|
17 U/L
Interval 14.0 to 20.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
AST (U/L)- Day 169 - 183
|
19 U/L
Interval 17.0 to 22.0
|
20.5 U/L
Interval 17.0 to 24.0
|
20 U/L
Interval 19.0 to 40.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
AST (U/L)- Day 252 - 267
|
18.5 U/L
Interval 16.5 to 21.5
|
20 U/L
Interval 17.0 to 24.0
|
—
|
—
|
19 U/L
Interval 13.5 to 27.5
|
—
|
|
Chemistry and Hematology Laboratory Measures
AST (U/L)- Day 442 - 456
|
—
|
—
|
17 U/L
Interval 16.0 to 39.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
Alkaline Phosphatase (U/L)- Screening
|
65 U/L
Interval 58.0 to 85.0
|
61 U/L
Interval 49.0 to 69.0
|
71 U/L
Interval 60.0 to 87.0
|
52.5 U/L
Interval 46.0 to 60.5
|
55.5 U/L
Interval 55.0 to 73.0
|
97 U/L
Interval 97.0 to 97.0
|
|
Chemistry and Hematology Laboratory Measures
Alkaline Phosphatase (U/L)- Day 1 - 15
|
65 U/L
Interval 61.0 to 73.0
|
60 U/L
Interval 53.0 to 70.0
|
69 U/L
Interval 63.0 to 80.0
|
54 U/L
Interval 45.5 to 62.0
|
60.5 U/L
Interval 58.0 to 74.0
|
—
|
|
Chemistry and Hematology Laboratory Measures
Alkaline Phosphatase (U/L)- Day 57 - 71
|
67 U/L
Interval 61.0 to 74.0
|
67 U/L
Interval 55.0 to 77.0
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
Alkaline Phosphatase (U/L)- Day 99 - 113
|
—
|
—
|
72 U/L
Interval 62.0 to 86.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
Alkaline Phosphatase (U/L)- Day 127 - 141
|
68 U/L
Interval 61.0 to 77.5
|
67.5 U/L
Interval 55.0 to 80.0
|
—
|
52 U/L
Interval 45.0 to 65.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
Alkaline Phosphatase (U/L)- Day 169 - 183
|
68.5 U/L
Interval 61.0 to 83.5
|
63 U/L
Interval 54.5 to 72.5
|
79.5 U/L
Interval 71.0 to 89.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures
Alkaline Phosphatase (U/L)- Day 252 - 267
|
68 U/L
Interval 56.5 to 83.0
|
59 U/L
Interval 52.0 to 68.0
|
—
|
—
|
70.5 U/L
Interval 56.0 to 96.5
|
—
|
|
Chemistry and Hematology Laboratory Measures
Alkaline Phosphatase (U/L)- Day 442 - 456
|
—
|
—
|
70 U/L
Interval 69.0 to 101.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Chemistry and Hematology Laboratory Measures - creatinine (g/dl), hemoglobin (g/dl)
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 Participants
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Creatinine (g/dL)- Day 127 - 141
|
0.00074 g/dl
Interval 0.00063 to 0.00079
|
0.000735 g/dl
Interval 0.00063 to 0.00084
|
—
|
0.00081 g/dl
Interval 0.00073 to 0.00091
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Hemoglobin (g/dL)- Screening
|
14.5 g/dl
Interval 13.4 to 15.0
|
14 g/dl
Interval 13.0 to 15.2
|
13.7 g/dl
Interval 13.7 to 16.6
|
14.75 g/dl
Interval 12.95 to 15.35
|
13.3 g/dl
Interval 12.4 to 14.9
|
14.9 g/dl
Interval 14.9 to 14.9
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Hemoglobin (g/dL)- Day 1 - 15
|
13.8 g/dl
Interval 13.1 to 14.6
|
13.3 g/dl
Interval 12.3 to 14.5
|
13.7 g/dl
Interval 12.6 to 15.2
|
14 g/dl
Interval 12.65 to 15.1
|
12.95 g/dl
Interval 11.9 to 15.0
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Hemoglobin (g/dL)- Day 57 - 71
|
14.1 g/dl
Interval 12.8 to 14.4
|
14 g/dl
Interval 12.6 to 14.5
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Hemoglobin (g/dL)- Day 99 - 113
|
—
|
—
|
14.6 g/dl
Interval 12.5 to 15.6
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Hemoglobin (g/dL)- Day 127 - 141
|
13.7 g/dl
Interval 12.7 to 14.5
|
13.25 g/dl
Interval 12.45 to 14.75
|
—
|
14.3 g/dl
Interval 12.9 to 15.9
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Hemoglobin (g/dL)- Day 169 - 183
|
14 g/dl
Interval 12.9 to 14.35
|
13 g/dl
Interval 12.2 to 14.8
|
13.7 g/dl
Interval 12.7 to 16.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Hemoglobin (g/dL)- Day 252 - 267
|
14.05 g/dl
Interval 13.2 to 14.4
|
13.4 g/dl
Interval 12.3 to 14.9
|
—
|
—
|
14.25 g/dl
Interval 12.8 to 14.6
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Hemoglobin (g/dL)- Day 442 - 456
|
—
|
—
|
14.6 g/dl
Interval 13.4 to 15.7
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Creatinine (g/dL)- Screening
|
0.00073 g/dl
Interval 0.00062 to 0.00082
|
0.00074 g/dl
Interval 0.0006 to 0.00083
|
0.00071 g/dl
Interval 0.0007 to 0.00085
|
0.00085 g/dl
Interval 0.00074 to 0.00091
|
0.00074 g/dl
Interval 0.0007 to 0.00089
|
0.00086 g/dl
Interval 0.00086 to 0.00086
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Creatinine (g/dL)- Day 1 - 15
|
0.00076 g/dl
Interval 0.00071 to 0.00085
|
0.00076 g/dl
Interval 0.00064 to 0.00094
|
0.00071 g/dl
Interval 0.00067 to 0.00086
|
0.0008 g/dl
Interval 0.000755 to 0.000945
|
0.000735 g/dl
Interval 0.00068 to 0.00096
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Creatinine (g/dL)- Day 57 - 71
|
0.00076 g/dl
Interval 0.00071 to 0.00081
|
0.00076 g/dl
Interval 0.00061 to 0.00086
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Creatinine (g/dL)- Day 99 - 113
|
—
|
—
|
0.00078 g/dl
Interval 0.00067 to 0.00089
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Creatinine (g/dL)- Day 169 - 183
|
0.00073 g/dl
Interval 0.00064 to 0.00077
|
0.0008 g/dl
Interval 0.000645 to 0.000905
|
0.000765 g/dl
Interval 0.00072 to 0.00082
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Creatinine (g/dL)- Day 252 - 267
|
0.000715 g/dl
Interval 0.000625 to 0.000775
|
0.00072 g/dl
Interval 0.00068 to 0.00085
|
—
|
—
|
0.00077 g/dl
Interval 0.00073 to 0.000875
|
—
|
|
Chemistry and Hematology Laboratory Measures - Creatinine, Hemoglobin
Creatinine (g/dL)- Day 442 - 456
|
—
|
—
|
0.00082 g/dl
Interval 0.00074 to 0.00096
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Chemistry and Hematology Laboratory Measures - lymphocyte count (1000/mm3), neutrophil count (1000/mm3), platelets (1000/mm3), white blood cells (WBC) (1000/mm3)
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 Participants
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Screening
|
6.37 1000/mm3
Interval 5.6 to 8.48
|
7.14 1000/mm3
Interval 6.24 to 8.39
|
8.31 1000/mm3
Interval 6.35 to 8.5
|
5.85 1000/mm3
Interval 4.45 to 7.15
|
6.45 1000/mm3
Interval 5.4 to 7.7
|
9.02 1000/mm3
Interval 9.02 to 9.02
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Day 1 - 15
|
5.9 1000/mm3
Interval 5.31 to 7.98
|
5.86 1000/mm3
Interval 4.91 to 7.28
|
6.53 1000/mm3
Interval 5.91 to 7.51
|
5.2 1000/mm3
Interval 4.2 to 6.45
|
6.35 1000/mm3
Interval 5.4 to 7.1
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Day 57 - 71
|
6.21 1000/mm3
Interval 4.95 to 7.11
|
7.26 1000/mm3
Interval 5.4 to 8.33
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Day 99 - 113
|
—
|
—
|
5.5 1000/mm3
Interval 4.72 to 7.91
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Day 127 - 141
|
6.395 1000/mm3
Interval 5.01 to 8.33
|
6.475 1000/mm3
Interval 5.065 to 7.035
|
—
|
5.5 1000/mm3
Interval 4.4 to 6.6
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Day 169 - 183
|
5.83 1000/mm3
Interval 4.34 to 6.665
|
6.2 1000/mm3
Interval 5.25 to 8.0
|
6.5 1000/mm3
Interval 5.31 to 7.11
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Day 252 - 267
|
6.21 1000/mm3
Interval 4.885 to 7.82
|
6.92 1000/mm3
Interval 5.14 to 7.81
|
—
|
—
|
6.45 1000/mm3
Interval 5.6 to 7.1
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
WBC (1000/cubic mm)- Day 442 - 456
|
—
|
—
|
5.67 1000/mm3
Interval 4.99 to 6.38
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000/cubic mm)- Screening
|
3.709 1000/mm3
Interval 2.996 to 5.357
|
4.185 1000/mm3
Interval 3.14 to 4.76
|
4.958 1000/mm3
Interval 4.0 to 5.32
|
3.494 1000/mm3
Interval 2.1795 to 4.215
|
3.4345 1000/mm3
Interval 2.604 to 5.028
|
6.747 1000/mm3
Interval 6.747 to 6.747
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000/cubic mm)- Day 1 - 15
|
3.336 1000/mm3
Interval 2.51 to 5.05
|
3.54 1000/mm3
Interval 2.468 to 4.16
|
3.853 1000/mm3
Interval 3.377 to 5.43
|
3.124 1000/mm3
Interval 2.2245 to 3.7045
|
3.733 1000/mm3
Interval 3.089 to 3.919
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000/cubic mm)- Day 57 - 71
|
3.3 1000/mm3
Interval 2.42 to 5.137
|
4 1000/mm3
Interval 2.984 to 4.615
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000/cubic mm)- Day 99 - 113
|
—
|
—
|
3.27 1000/mm3
Interval 2.57 to 4.516
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000/cubic mm)- Day 127 - 141
|
3.8025 1000/mm3
Interval 2.875 to 5.0905
|
3.4375 1000/mm3
Interval 2.5165 to 4.4505
|
—
|
3.26 1000/mm3
Interval 2.494 to 3.907
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000/cubic mm)- Day 169 - 183
|
3.63 1000/mm3
Interval 2.2105 to 4.2
|
3.14 1000/mm3
Interval 2.796 to 4.41
|
3.775 1000/mm3
Interval 3.159 to 4.264
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000/cubic mm)- Day 252 - 267
|
4.0245 1000/mm3
Interval 2.638 to 5.07
|
3.599 1000/mm3
Interval 2.66 to 5.05
|
—
|
—
|
3.301 1000/mm3
Interval 2.8055 to 3.9125
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Neutrophils (1000/cubic mm)- Day 442 - 456
|
—
|
—
|
3.02 1000/mm3
Interval 2.51 to 3.42
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000/cubic mm)- Screening
|
2.033 1000/mm3
Interval 1.793 to 2.32
|
2.198 1000/mm3
Interval 1.98 to 2.69
|
2.255 1000/mm3
Interval 1.81 to 3.22
|
1.875 1000/mm3
Interval 1.37 to 2.284
|
2.161 1000/mm3
Interval 1.62 to 2.85
|
1.741 1000/mm3
Interval 1.741 to 1.741
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000/cubic mm)- Day 1 - 15
|
1.93 1000/mm3
Interval 1.561 to 2.42
|
1.872 1000/mm3
Interval 1.562 to 2.48
|
2.21 1000/mm3
Interval 1.65 to 2.589
|
1.68 1000/mm3
Interval 1.39 to 1.9645
|
2.0345 1000/mm3
Interval 1.86 to 2.347
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000/cubic mm)- Day 57 - 71
|
1.7 1000/mm3
Interval 1.57 to 2.29
|
2.27 1000/mm3
Interval 1.58 to 2.62
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000/cubic mm)- Day 99 - 113
|
—
|
—
|
1.743 1000/mm3
Interval 1.54 to 2.079
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000/cubic mm)- Day 127 - 141
|
1.843 1000/mm3
Interval 1.4225 to 2.334
|
2.09 1000/mm3
Interval 1.5 to 2.58
|
—
|
1.72 1000/mm3
Interval 1.33 to 2.17
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000/cubic mm)- Day 169 - 183
|
1.7685 1000/mm3
Interval 1.46 to 2.0765
|
1.966 1000/mm3
Interval 1.58 to 2.49
|
1.7765 1000/mm3
Interval 1.608 to 2.14
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000/cubic mm)- Day 252 - 267
|
1.8045 1000/mm3
Interval 1.465 to 2.085
|
1.95 1000/mm3
Interval 1.576 to 2.45
|
—
|
—
|
2.251 1000/mm3
Interval 2.0645 to 2.342
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Lymphocytes (1000/cubic mm)- Day 442 - 456
|
—
|
—
|
2.156 1000/mm3
Interval 1.52 to 2.82
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Screening
|
256 1000/mm3
Interval 226.0 to 292.0
|
275 1000/mm3
Interval 203.0 to 314.0
|
281 1000/mm3
Interval 238.0 to 374.0
|
258 1000/mm3
Interval 229.5 to 301.0
|
270.5 1000/mm3
Interval 245.0 to 314.0
|
334 1000/mm3
Interval 334.0 to 334.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Day 1 - 15
|
255 1000/mm3
Interval 225.0 to 291.0
|
274 1000/mm3
Interval 203.0 to 305.0
|
285 1000/mm3
Interval 251.0 to 366.0
|
258.5 1000/mm3
Interval 213.0 to 302.0
|
278 1000/mm3
Interval 212.0 to 312.0
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Day 57 - 71
|
247 1000/mm3
Interval 210.0 to 279.0
|
285 1000/mm3
Interval 214.0 to 319.0
|
—
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Day 99 - 113
|
—
|
—
|
290 1000/mm3
Interval 265.0 to 305.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Day 127 - 141
|
258 1000/mm3
Interval 228.0 to 323.5
|
294 1000/mm3
Interval 220.0 to 312.0
|
—
|
274 1000/mm3
Interval 218.0 to 310.0
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Day 169 - 183
|
249 1000/mm3
Interval 217.0 to 274.0
|
261 1000/mm3
Interval 197.0 to 302.0
|
278 1000/mm3
Interval 260.0 to 415.0
|
—
|
—
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Day 252 - 267
|
253 1000/mm3
Interval 221.5 to 276.0
|
266.5 1000/mm3
Interval 224.5 to 308.5
|
—
|
—
|
259.5 1000/mm3
Interval 194.0 to 325.5
|
—
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, White Blood Cells (WBC)
Platelets (1000/cubic mm)- Day 442 - 456
|
—
|
—
|
269 1000/mm3
Interval 229.0 to 336.0
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through IV infusion at visits 1 (screening), 4 (day 1-15), 7 (day 57-71), 10 (day 99-113), 12 (day 127-141), 14 (day 169-183), 16 (day 252-267), and 18 (day 442-456) (visits depending on which group participants are in)Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0.
Number of Participants with Chemistry and Hematology Laboratory Measures - Counts of Lab Grade \> 1 for alkaline phosphate (ALP), aspartate aminotransferase (AST), alanine aminotransferase (ALT), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC).
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 Participants
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)- Day 1 - 15
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
AST (U/L)- DayScreening
|
0 Participants
|
0 Participants
|
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 57 - 71
|
0 Participants
|
0 Participants
|
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 99 - 113
|
0 Participants
|
0 Participants
|
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 127 - 141
|
0 Participants
|
0 Participants
|
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 169 - 183
|
0 Participants
|
0 Participants
|
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 252 - 267
|
0 Participants
|
0 Participants
|
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 442 - 456
|
0 Participants
|
0 Participants
|
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)- DayScreening
|
0 Participants
|
0 Participants
|
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 1 - 15
|
0 Participants
|
0 Participants
|
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 57 - 71
|
0 Participants
|
0 Participants
|
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 442 - 456
|
0 Participants
|
0 Participants
|
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 169 - 183
|
0 Participants
|
0 Participants
|
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 252 - 267
|
0 Participants
|
0 Participants
|
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 99 - 113
|
0 Participants
|
0 Participants
|
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 127 - 141
|
0 Participants
|
0 Participants
|
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)- DayScreening
|
0 Participants
|
0 Participants
|
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 1 - 15
|
1 Participants
|
1 Participants
|
1 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 57 - 71
|
0 Participants
|
1 Participants
|
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 99 - 113
|
0 Participants
|
0 Participants
|
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 127 - 141
|
0 Participants
|
0 Participants
|
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 169 - 183
|
0 Participants
|
3 Participants
|
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 252 - 267
|
1 Participants
|
1 Participants
|
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 442 - 456
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000/cubic mm)- Day 99 - 113
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000/cubic mm)- Day 127 - 141
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000/cubic mm)- Day 169 - 183
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000/cubic mm)- Day 252 - 267
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000/cubic mm)- Day 442 - 456
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000/cubic mm)- DayScreening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000/cubic mm)- Day 1 - 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000/cubic mm)- Day 57 - 71
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000/cubic mm)- Day 99 - 113
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000/cubic mm)- Day 127 - 141
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000/cubic mm)- Day 169 - 183
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000/cubic mm)- Day 252 - 267
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Platelets (1000/cubic mm)- Day 442 - 456
|
0 Participants
|
0 Participants
|
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)- DayScreening
|
0 Participants
|
0 Participants
|
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 1 - 15
|
0 Participants
|
0 Participants
|
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 57 - 71
|
0 Participants
|
0 Participants
|
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 99 - 113
|
0 Participants
|
0 Participants
|
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 127 - 141
|
0 Participants
|
0 Participants
|
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 169 - 183
|
0 Participants
|
0 Participants
|
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 252 - 267
|
0 Participants
|
0 Participants
|
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 442 - 456
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000/cubic mm)- DayScreening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000/cubic mm)- Day 1 - 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000/cubic mm)- Day 57 - 71
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000/cubic mm)- Day 99 - 113
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000/cubic mm)- Day 127 - 141
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000/cubic mm)- Day 169 - 183
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000/cubic mm)- Day 252 - 267
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
WBC (1000/cubic mm)- Day 442 - 456
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000/cubic mm)- DayScreening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000/cubic mm)- Day 1 - 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000/cubic mm)- Day 57 - 71
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000/cubic mm)- Day 99 - 113
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000/cubic mm)- Day 127 - 141
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000/cubic mm)- Day 169 - 183
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000/cubic mm)- Day 252 - 267
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Neutrophils (1000/cubic mm)- Day 442 - 456
|
0 Participants
|
0 Participants
|
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)- DayScreening
|
0 Participants
|
0 Participants
|
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 1 - 15
|
0 Participants
|
0 Participants
|
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 57 - 71
|
0 Participants
|
0 Participants
|
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 99 - 113
|
0 Participants
|
0 Participants
|
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 127 - 141
|
0 Participants
|
0 Participants
|
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 169 - 183
|
0 Participants
|
0 Participants
|
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 252 - 267
|
0 Participants
|
0 Participants
|
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 442 - 456
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000/cubic mm)- DayScreening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000/cubic mm)- Day 1 - 15
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants With Chemistry and Hematology Laboratory Measures - Counts of Lab Grade > 1
Lymphocytes (1000/cubic mm)- Day 57 - 71
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)For participants reporting multiple AEs over the time frame, the maximum severity is counted
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 Participants
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Adverse Events (AEs)
Mild
|
5 Participants
|
3 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
Moderate
|
16 Participants
|
11 Participants
|
6 Participants
|
5 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
Severe
|
1 Participants
|
4 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
Potentially life-threatening
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Adverse Events (AEs)
No AE reported
|
1 Participants
|
5 Participants
|
0 Participants
|
9 Participants
|
7 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)For participants reporting multiple AEs over the time frame, the maximum severity is counted
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 Participants
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
SAE
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Serious Adverse Events (SAEs)
No SAE reported
|
23 Participants
|
22 Participants
|
6 Participants
|
16 Participants
|
9 Participants
|
1 Participants
|
PRIMARY outcome
Timeframe: Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)Tabulated by reason for discontinuation and treatment arm
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 Participants
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 Participants
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Rates of Participant Discontinuation
Coenrolled with an investigational agent
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Rates of Participant Discontinuation
Terminated to donate bone marrow
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Rates of Participant Discontinuation
Refused study product administration
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Rates of Participant Discontinuation
Clinical event (not reacto, HIV, death)
|
1 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Rates of Participant Discontinuation
Unable to contact participant for visits
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
|
Rates of Participant Discontinuation
Did not discontinue SPA
|
19 Participants
|
22 Participants
|
6 Participants
|
16 Participants
|
10 Participants
|
—
|
PRIMARY outcome
Timeframe: Measured through 6 months after the last infusionPopulation: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS.
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=16 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 2
|
0.02 µg/mL
Interval 0.02 to 0.02
|
0.02 µg/mL
Interval 0.02 to 0.02
|
—
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 2
|
0.02 µg/mL
Interval 0.02 to 0.02
|
0.02 µg/mL
Interval 0.02 to 0.02
|
—
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 3
|
—
|
—
|
0.05 µg/mL
Interval 0.02 to 0.08
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 3
|
—
|
—
|
0.05 µg/mL
Interval 0.02 to 0.13
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 4
|
72.42 µg/mL
Interval 62.99 to 99.58
|
215.65 µg/mL
Interval 172.82 to 271.26
|
194.99 µg/mL
Interval 177.75 to 215.86
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 5
|
19.57 µg/mL
Interval 10.11 to 24.03
|
54.09 µg/mL
Interval 40.84 to 58.16
|
60.48 µg/mL
Interval 53.49 to 74.24
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 7
|
50.95 µg/mL
Interval 42.03 to 82.81
|
202.99 µg/mL
Interval 153.76 to 271.53
|
29.72 µg/mL
Interval 19.91 to 36.55
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 4
|
64.83 µg/mL
Interval 48.7 to 129.28
|
185.55 µg/mL
Interval 140.18 to 211.36
|
240.46 µg/mL
Interval 220.3 to 335.77
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 5
|
19.77 µg/mL
Interval 14.53 to 25.6
|
49.27 µg/mL
Interval 41.83 to 62.52
|
72.31 µg/mL
Interval 71.59 to 73.77
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 9
|
13.48 µg/mL
Interval 7.85 to 18.73
|
54.76 µg/mL
Interval 43.67 to 63.84
|
8.51 µg/mL
Interval 6.55 to 12.15
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 9
|
14.84 µg/mL
Interval 13.27 to 17.46
|
49.05 µg/mL
Interval 46.68 to 53.2
|
5.81 µg/mL
Interval 4.14 to 16.84
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 7
|
62.08 µg/mL
Interval 52.76 to 105.56
|
274.67 µg/mL
Interval 227.19 to 364.53
|
20.99 µg/mL
Interval 15.45 to 38.65
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 12
|
29.11 µg/mL
Interval 22.83 to 36.53
|
112.28 µg/mL
Interval 94.48 to 128.0
|
1.65 µg/mL
Interval 1.3 to 2.72
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 12
|
36.48 µg/mL
Interval 28.65 to 51.21
|
104.97 µg/mL
Interval 94.57 to 116.37
|
1.71 µg/mL
Interval 1.05 to 4.85
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 14
|
81.92 µg/mL
Interval 63.44 to 104.76
|
174.79 µg/mL
Interval 132.71 to 226.69
|
0.66 µg/mL
Interval 0.55 to 0.84
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 14
|
72.35 µg/mL
Interval 59.34 to 150.89
|
228.43 µg/mL
Interval 191.91 to 264.03
|
0.67 µg/mL
Interval 0.48 to 1.06
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 15
|
9.6 µg/mL
Interval 8.64 to 16.55
|
26.85 µg/mL
Interval 21.48 to 32.15
|
—
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 15
|
11.5 µg/mL
Interval 8.73 to 51.29
|
62.81 µg/mL
Interval 41.08 to 79.96
|
—
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 16
|
1.25 µg/mL
Interval 0.64 to 1.96
|
3.03 µg/mL
Interval 1.7 to 7.35
|
—
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 16
|
1.12 µg/mL
Interval 0.73 to 4.82
|
6.85 µg/mL
Interval 3.02 to 18.29
|
—
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 17
|
0.02 µg/mL
Interval 0.02 to 0.1
|
0.11 µg/mL
Interval 0.08 to 0.55
|
—
|
—
|
—
|
—
|
|
Unnormalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 17
|
0.03 µg/mL
Interval 0.02 to 0.17
|
0.15 µg/mL
Interval 0.05 to 0.43
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through 6 months after the last infusionPopulation: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL)
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=16 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 2
|
0 pg mAb/ng IgG
Interval 0.0 to 0.0
|
0 pg mAb/ng IgG
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 2
|
0 pg mAb/ng IgG
Interval 0.0 to 0.0
|
0 pg mAb/ng IgG
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 3
|
—
|
—
|
0 pg mAb/ng IgG
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 3
|
—
|
—
|
0.01 pg mAb/ng IgG
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 4
|
6.28 pg mAb/ng IgG
Interval 4.98 to 7.32
|
13.82 pg mAb/ng IgG
Interval 11.41 to 23.35
|
17.02 pg mAb/ng IgG
Interval 16.1 to 25.71
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 4
|
6.8 pg mAb/ng IgG
Interval 3.61 to 10.16
|
12.94 pg mAb/ng IgG
Interval 8.1 to 16.54
|
22.1 pg mAb/ng IgG
Interval 17.5 to 27.14
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 5
|
1.54 pg mAb/ng IgG
Interval 0.73 to 2.68
|
4 pg mAb/ng IgG
Interval 2.52 to 5.09
|
7.09 pg mAb/ng IgG
Interval 4.28 to 9.57
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 5
|
1.44 pg mAb/ng IgG
Interval 0.69 to 2.89
|
3.59 pg mAb/ng IgG
Interval 2.49 to 5.02
|
5.48 pg mAb/ng IgG
Interval 3.4 to 7.25
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 7
|
4.26 pg mAb/ng IgG
Interval 2.78 to 7.3
|
19.67 pg mAb/ng IgG
Interval 11.04 to 23.09
|
2.31 pg mAb/ng IgG
Interval 1.84 to 3.48
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 7
|
5.75 pg mAb/ng IgG
Interval 3.28 to 7.04
|
23.75 pg mAb/ng IgG
Interval 19.2 to 24.5
|
1.62 pg mAb/ng IgG
Interval 1.07 to 2.32
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 9
|
0.9 pg mAb/ng IgG
Interval 0.63 to 1.68
|
3.61 pg mAb/ng IgG
Interval 3.26 to 4.49
|
0.79 pg mAb/ng IgG
Interval 0.54 to 1.17
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 9
|
1 pg mAb/ng IgG
Interval 0.83 to 1.74
|
3.55 pg mAb/ng IgG
Interval 2.92 to 5.13
|
0.41 pg mAb/ng IgG
Interval 0.31 to 1.32
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 12
|
1.94 pg mAb/ng IgG
Interval 1.26 to 2.76
|
8.41 pg mAb/ng IgG
Interval 6.4 to 11.49
|
0.15 pg mAb/ng IgG
Interval 0.11 to 0.25
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 12
|
3.07 pg mAb/ng IgG
Interval 1.49 to 4.68
|
7.49 pg mAb/ng IgG
Interval 5.81 to 9.33
|
0.13 pg mAb/ng IgG
Interval 0.07 to 0.34
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 14
|
6.55 pg mAb/ng IgG
Interval 4.24 to 10.13
|
13.11 pg mAb/ng IgG
Interval 8.17 to 19.83
|
0.06 pg mAb/ng IgG
Interval 0.05 to 0.07
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 14
|
7.13 pg mAb/ng IgG
Interval 5.29 to 13.1
|
21.79 pg mAb/ng IgG
Interval 11.23 to 24.13
|
0.06 pg mAb/ng IgG
Interval 0.03 to 0.08
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 15
|
0.78 pg mAb/ng IgG
Interval 0.63 to 1.43
|
1.88 pg mAb/ng IgG
Interval 1.11 to 3.41
|
—
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 15
|
0.84 pg mAb/ng IgG
Interval 0.57 to 5.41
|
3.38 pg mAb/ng IgG
Interval 2.91 to 5.56
|
—
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 16
|
0.09 pg mAb/ng IgG
Interval 0.04 to 0.12
|
0.17 pg mAb/ng IgG
Interval 0.14 to 0.74
|
—
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 16
|
0.08 pg mAb/ng IgG
Interval 0.05 to 0.48
|
0.39 pg mAb/ng IgG
Interval 0.16 to 1.72
|
—
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 17
|
0 pg mAb/ng IgG
Interval 0.0 to 0.01
|
0.01 pg mAb/ng IgG
Interval 0.0 to 0.05
|
—
|
—
|
—
|
—
|
|
IgG-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 17
|
0 pg mAb/ng IgG
Interval 0.0 to 0.01
|
0.01 pg mAb/ng IgG
Interval 0.0 to 0.03
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through 6 months after the last infusionPopulation: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL)
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=16 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 3
|
—
|
—
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 3
|
—
|
—
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 4
|
0.87 pg mAb/ng total protein
Interval 0.7 to 1.01
|
2.5 pg mAb/ng total protein
Interval 1.89 to 3.15
|
2.39 pg mAb/ng total protein
Interval 1.89 to 2.79
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 4
|
0.78 pg mAb/ng total protein
Interval 0.48 to 1.64
|
2.04 pg mAb/ng total protein
Interval 1.74 to 2.45
|
2.77 pg mAb/ng total protein
Interval 2.29 to 3.7
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 5
|
0.21 pg mAb/ng total protein
Interval 0.17 to 0.28
|
0.6 pg mAb/ng total protein
Interval 0.52 to 0.76
|
0.88 pg mAb/ng total protein
Interval 0.8 to 0.91
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 5
|
0.21 pg mAb/ng total protein
Interval 0.12 to 0.27
|
0.65 pg mAb/ng total protein
Interval 0.5 to 0.7
|
0.63 pg mAb/ng total protein
Interval 0.56 to 0.84
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 7
|
0.66 pg mAb/ng total protein
Interval 0.47 to 0.92
|
2.34 pg mAb/ng total protein
Interval 1.76 to 3.19
|
0.33 pg mAb/ng total protein
Interval 0.22 to 0.4
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 7
|
0.67 pg mAb/ng total protein
Interval 0.63 to 1.3
|
3.66 pg mAb/ng total protein
Interval 2.49 to 3.83
|
0.19 pg mAb/ng total protein
Interval 0.17 to 0.43
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 9
|
0.16 pg mAb/ng total protein
Interval 0.1 to 0.21
|
0.68 pg mAb/ng total protein
Interval 0.45 to 0.74
|
0.1 pg mAb/ng total protein
Interval 0.08 to 0.15
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 9
|
0.18 pg mAb/ng total protein
Interval 0.14 to 0.21
|
0.6 pg mAb/ng total protein
Interval 0.52 to 0.61
|
0.06 pg mAb/ng total protein
Interval 0.05 to 0.23
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 12
|
0.35 pg mAb/ng total protein
Interval 0.26 to 0.44
|
1.22 pg mAb/ng total protein
Interval 1.1 to 1.29
|
0.02 pg mAb/ng total protein
Interval 0.02 to 0.03
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 12
|
0.39 pg mAb/ng total protein
Interval 0.3 to 0.56
|
1.22 pg mAb/ng total protein
Interval 1.12 to 1.34
|
0.02 pg mAb/ng total protein
Interval 0.01 to 0.06
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 14
|
0.9 pg mAb/ng total protein
Interval 0.73 to 1.2
|
2.07 pg mAb/ng total protein
Interval 1.59 to 2.48
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 14
|
0.84 pg mAb/ng total protein
Interval 0.56 to 1.62
|
2.59 pg mAb/ng total protein
Interval 2.18 to 2.8
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 15
|
0.1 pg mAb/ng total protein
Interval 0.1 to 0.17
|
0.32 pg mAb/ng total protein
Interval 0.26 to 0.41
|
—
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 15
|
0.15 pg mAb/ng total protein
Interval 0.1 to 0.54
|
0.69 pg mAb/ng total protein
Interval 0.4 to 0.71
|
—
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 16
|
0.02 pg mAb/ng total protein
Interval 0.01 to 0.02
|
0.03 pg mAb/ng total protein
Interval 0.02 to 0.1
|
—
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 16
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.06
|
0.07 pg mAb/ng total protein
Interval 0.03 to 0.2
|
—
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Female-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Protein-normalized Serum Concentration of VRC01 Out to Month 6 After the Last Infusion (for Groups 1, 2, and 4)
Serum-Male-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through 6 months after the last infusionPopulation: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the estimated concentration of VRC01/VRC01LS.
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=16 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 2
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 4
|
—
|
—
|
0.9 µg/mL
Interval 0.86 to 1.0
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 5
|
—
|
—
|
0.26 µg/mL
Interval 0.17 to 0.29
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 9
|
—
|
—
|
0.03 µg/mL
Interval 0.03 to 0.04
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 12
|
—
|
—
|
0.01 µg/mL
Interval 0.01 to 0.03
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 14
|
0.28 µg/mL
Interval 0.22 to 0.39
|
0.91 µg/mL
Interval 0.77 to 1.08
|
0.01 µg/mL
Interval 0.01 to 0.02
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 15
|
0.06 µg/mL
Interval 0.03 to 0.06
|
0.17 µg/mL
Interval 0.08 to 0.19
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 16
|
0.01 µg/mL
Interval 0.01 to 0.02
|
0.02 µg/mL
Interval 0.01 to 0.03
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 17
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 2
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 2
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 4
|
—
|
—
|
0.33 µg/mL
Interval 0.24 to 0.43
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 5
|
—
|
—
|
0.09 µg/mL
Interval 0.07 to 0.15
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 9
|
—
|
—
|
0.01 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 12
|
—
|
—
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 14
|
0.1 µg/mL
Interval 0.09 to 0.12
|
0.16 µg/mL
Interval 0.13 to 0.18
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 14
|
0.06 µg/mL
Interval 0.03 to 0.11
|
0.23 µg/mL
Interval 0.19 to 0.32
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 15
|
0.02 µg/mL
Interval 0.01 to 0.04
|
0.04 µg/mL
Interval 0.02 to 0.05
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 15
|
0.02 µg/mL
Interval 0.01 to 0.02
|
0.06 µg/mL
Interval 0.05 to 0.11
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 16
|
0 µg/mL
Interval 0.0 to 0.01
|
0.01 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 16
|
0 µg/mL
Interval 0.0 to 0.0
|
0.01 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 17
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 17
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 1
|
—
|
—
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 2
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 2
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 4
|
0 µg/mL
Interval 0.0 to 0.01
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 4
|
0 µg/mL
Interval 0.0 to 0.01
|
0.02 µg/mL
Interval 0.0 to 0.09
|
0.01 µg/mL
Interval 0.01 to 0.01
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 5
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.05
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 5
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.01
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 7
|
0 µg/mL
Interval 0.0 to 0.0
|
0.01 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 7
|
0.01 µg/mL
Interval 0.0 to 0.01
|
0.02 µg/mL
Interval 0.01 to 0.11
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 9
|
0 µg/mL
Interval 0.0 to 0.0
|
0.01 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 9
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.04
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 12
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 12
|
0 µg/mL
Interval 0.0 to 0.01
|
0 µg/mL
Interval 0.0 to 0.01
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 14
|
0 µg/mL
Interval 0.0 to 0.02
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 14
|
0 µg/mL
Interval 0.0 to 0.04
|
0 µg/mL
Interval 0.0 to 0.03
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 15
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 15
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 16
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 16
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 17
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 17
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 1
|
—
|
—
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 2
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 4
|
0.15 µg/mL
Interval 0.08 to 0.2
|
0.43 µg/mL
Interval 0.37 to 0.56
|
0.49 µg/mL
Interval 0.3 to 0.58
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 5
|
0.05 µg/mL
Interval 0.02 to 0.06
|
0.14 µg/mL
Interval 0.09 to 0.2
|
0.16 µg/mL
Interval 0.14 to 0.26
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 7
|
0.14 µg/mL
Interval 0.11 to 0.19
|
0.46 µg/mL
Interval 0.34 to 0.62
|
0.05 µg/mL
Interval 0.04 to 0.09
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 9
|
0.04 µg/mL
Interval 0.03 to 0.07
|
0.17 µg/mL
Interval 0.12 to 0.19
|
0.02 µg/mL
Interval 0.01 to 0.03
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 12
|
0.12 µg/mL
Interval 0.1 to 0.15
|
0.32 µg/mL
Interval 0.25 to 0.34
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 14
|
0.13 µg/mL
Interval 0.1 to 0.17
|
0.42 µg/mL
Interval 0.36 to 0.87
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 15
|
0.04 µg/mL
Interval 0.02 to 0.06
|
0.12 µg/mL
Interval 0.07 to 0.2
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 16
|
0.01 µg/mL
Interval 0.0 to 0.02
|
0.01 µg/mL
Interval 0.01 to 0.02
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 17
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 1
|
—
|
—
|
0.02 µg/mL
Interval 0.01 to 0.02
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 2
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 4
|
0.28 µg/mL
Interval 0.23 to 0.5
|
0.67 µg/mL
Interval 0.59 to 0.75
|
0.93 µg/mL
Interval 0.8 to 1.27
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 5
|
0.04 µg/mL
Interval 0.02 to 0.07
|
0.16 µg/mL
Interval 0.1 to 0.33
|
0.2 µg/mL
Interval 0.18 to 0.21
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 7
|
0.29 µg/mL
Interval 0.17 to 0.31
|
0.97 µg/mL
Interval 0.73 to 1.43
|
0.08 µg/mL
Interval 0.03 to 0.14
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 9
|
0.04 µg/mL
Interval 0.04 to 0.08
|
0.24 µg/mL
Interval 0.21 to 0.27
|
0.06 µg/mL
Interval 0.04 to 0.08
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 12
|
0.43 µg/mL
Interval 0.34 to 0.52
|
0.71 µg/mL
Interval 0.49 to 1.16
|
0.01 µg/mL
Interval 0.01 to 0.01
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 14
|
0.33 µg/mL
Interval 0.26 to 0.4
|
0.6 µg/mL
Interval 0.28 to 0.91
|
0.01 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 15
|
0.09 µg/mL
Interval 0.04 to 0.11
|
0.09 µg/mL
Interval 0.03 to 0.17
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 16
|
0.01 µg/mL
Interval 0.01 to 0.01
|
0.04 µg/mL
Interval 0.01 to 0.14
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 17
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 2
|
0 µg/mL
Interval 0.0 to 0.0
|
0 µg/mL
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 4
|
—
|
—
|
0.7 µg/mL
Interval 0.55 to 1.4
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 5
|
—
|
—
|
0.29 µg/mL
Interval 0.15 to 0.69
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 9
|
—
|
—
|
0.03 µg/mL
Interval 0.02 to 0.03
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 12
|
—
|
—
|
0.01 µg/mL
Interval 0.01 to 0.03
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 14
|
0.13 µg/mL
Interval 0.07 to 0.38
|
0.87 µg/mL
Interval 0.73 to 1.1
|
0.01 µg/mL
Interval 0.01 to 0.02
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 15
|
0.05 µg/mL
Interval 0.02 to 0.06
|
0.11 µg/mL
Interval 0.04 to 0.17
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 16
|
0.01 µg/mL
Interval 0.0 to 0.01
|
0.03 µg/mL
Interval 0.01 to 0.04
|
—
|
—
|
—
|
—
|
|
Unnormalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 17
|
0 µg/mL
Interval 0.0 to 0.0
|
0.01 µg/mL
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through 6 months after the last infusionPopulation: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total IgG levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the IgG-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total IgG concentrations (ng/mL)
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=16 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 5
|
1.35 pg mAb/ng IgG
Interval 0.98 to 2.62
|
5.06 pg mAb/ng IgG
Interval 4.13 to 5.97
|
6.22 pg mAb/ng IgG
Interval 4.18 to 8.26
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 2
|
0.06 pg mAb/ng IgG
Interval 0.02 to 0.09
|
0.02 pg mAb/ng IgG
Interval 0.01 to 0.03
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 4
|
—
|
—
|
25.6 pg mAb/ng IgG
Interval 24.7 to 29.54
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 5
|
—
|
—
|
7.53 pg mAb/ng IgG
Interval 4.5 to 9.92
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 9
|
—
|
—
|
0.99 pg mAb/ng IgG
Interval 0.68 to 1.47
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 12
|
—
|
—
|
0.52 pg mAb/ng IgG
Interval 0.19 to 1.12
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 14
|
7.02 pg mAb/ng IgG
Interval 4.52 to 8.53
|
14.6 pg mAb/ng IgG
Interval 10.88 to 20.54
|
0.23 pg mAb/ng IgG
Interval 0.16 to 0.83
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 15
|
0.95 pg mAb/ng IgG
Interval 0.8 to 1.94
|
3.12 pg mAb/ng IgG
Interval 1.39 to 5.05
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 16
|
0.17 pg mAb/ng IgG
Interval 0.12 to 0.3
|
0.47 pg mAb/ng IgG
Interval 0.34 to 1.32
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 17
|
0.06 pg mAb/ng IgG
Interval 0.04 to 0.08
|
0.06 pg mAb/ng IgG
Interval 0.04 to 0.08
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 2
|
0.01 pg mAb/ng IgG
Interval 0.01 to 0.02
|
0.04 pg mAb/ng IgG
Interval 0.01 to 0.4
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 2
|
0.02 pg mAb/ng IgG
Interval 0.01 to 0.05
|
0.02 pg mAb/ng IgG
Interval 0.01 to 0.04
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 4
|
—
|
—
|
26.33 pg mAb/ng IgG
Interval 22.03 to 32.85
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 5
|
—
|
—
|
6.38 pg mAb/ng IgG
Interval 4.16 to 7.5
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 9
|
—
|
—
|
0.48 pg mAb/ng IgG
Interval 0.35 to 0.94
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 12
|
—
|
—
|
0.15 pg mAb/ng IgG
Interval 0.12 to 0.42
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 14
|
9.59 pg mAb/ng IgG
Interval 4.52 to 11.29
|
9.81 pg mAb/ng IgG
Interval 9.46 to 10.16
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 14
|
10.97 pg mAb/ng IgG
Interval 5.15 to 11.45
|
17.89 pg mAb/ng IgG
Interval 11.6 to 21.82
|
0.07 pg mAb/ng IgG
Interval 0.04 to 0.13
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 15
|
2.1 pg mAb/ng IgG
Interval 1.03 to 2.44
|
1.92 pg mAb/ng IgG
Interval 1.54 to 3.53
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 15
|
1.07 pg mAb/ng IgG
Interval 0.64 to 1.89
|
4.34 pg mAb/ng IgG
Interval 2.09 to 4.89
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 16
|
0.32 pg mAb/ng IgG
Interval 0.23 to 0.4
|
0.4 pg mAb/ng IgG
Interval 0.37 to 0.76
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 16
|
0.07 pg mAb/ng IgG
Interval 0.04 to 0.28
|
0.44 pg mAb/ng IgG
Interval 0.33 to 0.69
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 17
|
0.1 pg mAb/ng IgG
Interval 0.1 to 0.1
|
0.02 pg mAb/ng IgG
Interval 0.01 to 0.05
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 17
|
0.02 pg mAb/ng IgG
Interval 0.01 to 0.09
|
0.01 pg mAb/ng IgG
Interval 0.01 to 0.03
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 1
|
—
|
—
|
0.15 pg mAb/ng IgG
Interval 0.12 to 0.29
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 2
|
0.15 pg mAb/ng IgG
Interval 0.11 to 0.34
|
0.23 pg mAb/ng IgG
Interval 0.1 to 0.49
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 2
|
0.2 pg mAb/ng IgG
Interval 0.09 to 0.3
|
0.09 pg mAb/ng IgG
Interval 0.02 to 0.24
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 4
|
2.54 pg mAb/ng IgG
Interval 1.8 to 2.71
|
7.02 pg mAb/ng IgG
Interval 5.19 to 12.83
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 4
|
2.6 pg mAb/ng IgG
Interval 2.01 to 3.11
|
4.51 pg mAb/ng IgG
Interval 3.66 to 7.49
|
13.07 pg mAb/ng IgG
Interval 8.04 to 15.44
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 5
|
0.39 pg mAb/ng IgG
Interval 0.18 to 0.6
|
1.97 pg mAb/ng IgG
Interval 1.47 to 2.3
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 5
|
0.78 pg mAb/ng IgG
Interval 0.26 to 0.85
|
1.56 pg mAb/ng IgG
Interval 1.38 to 2.4
|
2.81 pg mAb/ng IgG
Interval 1.68 to 4.13
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 7
|
1.15 pg mAb/ng IgG
Interval 0.48 to 3.03
|
7.63 pg mAb/ng IgG
Interval 6.77 to 8.45
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 7
|
2.81 pg mAb/ng IgG
Interval 1.61 to 4.5
|
6.46 pg mAb/ng IgG
Interval 6.1 to 7.81
|
1.23 pg mAb/ng IgG
Interval 0.93 to 1.97
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 9
|
0.28 pg mAb/ng IgG
Interval 0.26 to 1.15
|
2.55 pg mAb/ng IgG
Interval 1.49 to 4.69
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 9
|
0.9 pg mAb/ng IgG
Interval 0.57 to 1.21
|
2.62 pg mAb/ng IgG
Interval 0.97 to 3.17
|
0.18 pg mAb/ng IgG
Interval 0.11 to 0.59
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 12
|
0.89 pg mAb/ng IgG
Interval 0.48 to 0.94
|
2.38 pg mAb/ng IgG
Interval 1.25 to 3.49
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 12
|
0.9 pg mAb/ng IgG
Interval 0.53 to 1.3
|
1.91 pg mAb/ng IgG
Interval 1.15 to 4.93
|
0.2 pg mAb/ng IgG
Interval 0.15 to 0.38
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 14
|
1.14 pg mAb/ng IgG
Interval 0.47 to 3.82
|
4.81 pg mAb/ng IgG
Interval 2.81 to 9.31
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 14
|
3.85 pg mAb/ng IgG
Interval 1.55 to 5.4
|
7.18 pg mAb/ng IgG
Interval 3.57 to 9.49
|
0.26 pg mAb/ng IgG
Interval 0.07 to 0.61
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 15
|
0.32 pg mAb/ng IgG
Interval 0.24 to 1.02
|
1.02 pg mAb/ng IgG
Interval 0.97 to 1.26
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 15
|
0.62 pg mAb/ng IgG
Interval 0.56 to 2.05
|
1.43 pg mAb/ng IgG
Interval 0.57 to 1.95
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 16
|
0.29 pg mAb/ng IgG
Interval 0.28 to 0.31
|
0.77 pg mAb/ng IgG
Interval 0.39 to 1.19
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 16
|
0.33 pg mAb/ng IgG
Interval 0.11 to 0.57
|
0.44 pg mAb/ng IgG
Interval 0.33 to 0.71
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 17
|
2.12 pg mAb/ng IgG
Interval 2.12 to 2.12
|
0.1 pg mAb/ng IgG
Interval 0.07 to 0.56
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 17
|
0.07 pg mAb/ng IgG
Interval 0.06 to 0.17
|
0.1 pg mAb/ng IgG
Interval 0.05 to 0.13
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 1
|
—
|
—
|
0.01 pg mAb/ng IgG
Interval 0.01 to 0.03
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 2
|
0 pg mAb/ng IgG
Interval 0.0 to 0.01
|
0 pg mAb/ng IgG
Interval 0.0 to 0.12
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 4
|
5.27 pg mAb/ng IgG
Interval 3.18 to 6.43
|
13.2 pg mAb/ng IgG
Interval 8.94 to 21.71
|
20.07 pg mAb/ng IgG
Interval 15.15 to 23.9
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 5
|
1.88 pg mAb/ng IgG
Interval 0.75 to 2.81
|
5.18 pg mAb/ng IgG
Interval 3.08 to 5.89
|
7.07 pg mAb/ng IgG
Interval 4.96 to 8.52
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 7
|
5.08 pg mAb/ng IgG
Interval 4.52 to 6.58
|
12.66 pg mAb/ng IgG
Interval 9.34 to 22.56
|
2.47 pg mAb/ng IgG
Interval 1.85 to 3.43
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 9
|
1.03 pg mAb/ng IgG
Interval 0.65 to 1.47
|
5.17 pg mAb/ng IgG
Interval 3.35 to 7.28
|
1 pg mAb/ng IgG
Interval 0.65 to 1.52
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 12
|
2.88 pg mAb/ng IgG
Interval 1.53 to 4.37
|
9.72 pg mAb/ng IgG
Interval 6.88 to 10.67
|
0.14 pg mAb/ng IgG
Interval 0.09 to 0.35
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 14
|
5.54 pg mAb/ng IgG
Interval 3.54 to 6.14
|
14.45 pg mAb/ng IgG
Interval 10.11 to 18.05
|
0.06 pg mAb/ng IgG
Interval 0.04 to 0.07
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 15
|
1.47 pg mAb/ng IgG
Interval 0.71 to 2.09
|
3.87 pg mAb/ng IgG
Interval 2.54 to 5.91
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 16
|
0.17 pg mAb/ng IgG
Interval 0.06 to 0.62
|
0.39 pg mAb/ng IgG
Interval 0.16 to 0.89
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 17
|
0.01 pg mAb/ng IgG
Interval 0.0 to 0.01
|
0.01 pg mAb/ng IgG
Interval 0.01 to 0.02
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 1
|
—
|
—
|
0.49 pg mAb/ng IgG
Interval 0.35 to 0.52
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 2
|
0.04 pg mAb/ng IgG
Interval 0.02 to 0.07
|
0.05 pg mAb/ng IgG
Interval 0.03 to 0.05
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 4
|
6.57 pg mAb/ng IgG
Interval 5.87 to 6.6
|
15.26 pg mAb/ng IgG
Interval 13.93 to 16.59
|
14.7 pg mAb/ng IgG
Interval 12.92 to 30.29
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 7
|
4.31 pg mAb/ng IgG
Interval 3.05 to 4.61
|
16.27 pg mAb/ng IgG
Interval 13.22 to 19.9
|
3.75 pg mAb/ng IgG
Interval 1.48 to 3.97
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 9
|
0.85 pg mAb/ng IgG
Interval 0.66 to 1.34
|
4.78 pg mAb/ng IgG
Interval 4.67 to 5.37
|
1.28 pg mAb/ng IgG
Interval 1.02 to 1.51
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 12
|
2.45 pg mAb/ng IgG
Interval 2.24 to 2.66
|
9.43 pg mAb/ng IgG
Interval 6.84 to 12.65
|
0.33 pg mAb/ng IgG
Interval 0.17 to 0.44
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 14
|
6.11 pg mAb/ng IgG
Interval 4.29 to 6.87
|
11.51 pg mAb/ng IgG
Interval 7.2 to 15.3
|
0.14 pg mAb/ng IgG
Interval 0.08 to 0.19
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 15
|
0.57 pg mAb/ng IgG
Interval 0.51 to 1.03
|
2.05 pg mAb/ng IgG
Interval 0.67 to 3.14
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 16
|
0.11 pg mAb/ng IgG
Interval 0.08 to 0.13
|
1.08 pg mAb/ng IgG
Interval 0.53 to 1.54
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 17
|
0.09 pg mAb/ng IgG
Interval 0.02 to 0.15
|
0.05 pg mAb/ng IgG
Interval 0.03 to 0.12
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 2
|
0.04 pg mAb/ng IgG
Interval 0.02 to 0.06
|
0.03 pg mAb/ng IgG
Interval 0.02 to 0.04
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 4
|
—
|
—
|
25 pg mAb/ng IgG
Interval 20.39 to 34.94
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 5
|
—
|
—
|
6.55 pg mAb/ng IgG
Interval 4.74 to 7.79
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 9
|
—
|
—
|
0.71 pg mAb/ng IgG
Interval 0.64 to 1.42
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 12
|
—
|
—
|
0.66 pg mAb/ng IgG
Interval 0.47 to 0.77
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 14
|
7.29 pg mAb/ng IgG
Interval 5.29 to 8.13
|
17.29 pg mAb/ng IgG
Interval 11.7 to 24.46
|
0.2 pg mAb/ng IgG
Interval 0.17 to 0.58
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 15
|
1 pg mAb/ng IgG
Interval 0.85 to 1.43
|
2.67 pg mAb/ng IgG
Interval 1.51 to 4.85
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 16
|
0.21 pg mAb/ng IgG
Interval 0.16 to 0.32
|
0.56 pg mAb/ng IgG
Interval 0.29 to 1.71
|
—
|
—
|
—
|
—
|
|
IgG-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 17
|
0.03 pg mAb/ng IgG
Interval 0.01 to 0.04
|
0.06 pg mAb/ng IgG
Interval 0.03 to 0.08
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Measured through 6 months after the last infusionPopulation: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Outcome measure will not be ready before the anticipated reporting date. VRC01/LS levels were measured by Singulex assay. VRC01/LS levels and total protein levels of study samples are calibrated via the respective standard curve on each assay plate. A five-parameter logistic (5PL) model is used to fit the standard curve data using the nCal package in R. Outcome measure is the protein-normalized VRC01/VRC01LS levels performed by dividing VRC01/LS levels (pg/mL) by the total protein concentrations (ng/mL)
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=16 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 4
|
—
|
—
|
1.12 pg mAb/ng total protein
Interval 0.93 to 1.26
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 5
|
—
|
—
|
0.24 pg mAb/ng total protein
Interval 0.23 to 0.26
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 9
|
—
|
—
|
0.04 pg mAb/ng total protein
Interval 0.03 to 0.05
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 12
|
—
|
—
|
0.02 pg mAb/ng total protein
Interval 0.01 to 0.03
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 14
|
0.3 pg mAb/ng total protein
Interval 0.26 to 0.48
|
0.87 pg mAb/ng total protein
Interval 0.84 to 0.96
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.03
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 15
|
0.05 pg mAb/ng total protein
Interval 0.04 to 0.1
|
0.16 pg mAb/ng total protein
Interval 0.1 to 0.22
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 16
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.02
|
0.03 pg mAb/ng total protein
Interval 0.01 to 0.05
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Cervical Biopsy Lysate-Female-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 4
|
—
|
—
|
0.41 pg mAb/ng total protein
Interval 0.3 to 0.53
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 5
|
—
|
—
|
0.08 pg mAb/ng total protein
Interval 0.06 to 0.12
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 9
|
—
|
—
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.02
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 12
|
—
|
—
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 14
|
0.13 pg mAb/ng total protein
Interval 0.09 to 0.18
|
0.17 pg mAb/ng total protein
Interval 0.16 to 0.19
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 14
|
0.1 pg mAb/ng total protein
Interval 0.07 to 0.17
|
0.23 pg mAb/ng total protein
Interval 0.2 to 0.39
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 15
|
0.03 pg mAb/ng total protein
Interval 0.02 to 0.04
|
0.04 pg mAb/ng total protein
Interval 0.03 to 0.04
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 15
|
0.02 pg mAb/ng total protein
Interval 0.01 to 0.03
|
0.06 pg mAb/ng total protein
Interval 0.05 to 0.1
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 16
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.02
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 16
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.02
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Female-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Biopsy Lysate-Male-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 1
|
—
|
—
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 4
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 4
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0.03 pg mAb/ng total protein
Interval 0.0 to 0.06
|
0.02 pg mAb/ng total protein
Interval 0.01 to 0.04
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 5
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.04
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 5
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 7
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.02
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 7
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0.03 pg mAb/ng total protein
Interval 0.02 to 0.1
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 9
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 9
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0 pg mAb/ng total protein
Interval 0.0 to 0.06
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 12
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 12
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.02
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 14
|
0 pg mAb/ng total protein
Interval 0.0 to 0.02
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 14
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.08
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.03
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 15
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 15
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 16
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 16
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Female-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Rectal Secretions-Male-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 1
|
—
|
—
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 4
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0.02 pg mAb/ng total protein
Interval 0.02 to 0.05
|
0.02 pg mAb/ng total protein
Interval 0.02 to 0.02
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 5
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 7
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0.02 pg mAb/ng total protein
Interval 0.02 to 0.03
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 9
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.02
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 12
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0.02 pg mAb/ng total protein
Interval 0.01 to 0.03
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 14
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
0.02 pg mAb/ng total protein
Interval 0.02 to 0.03
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 15
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.02
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 16
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Semen-Male-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 1
|
—
|
—
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.02
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 4
|
0.29 pg mAb/ng total protein
Interval 0.18 to 0.44
|
0.68 pg mAb/ng total protein
Interval 0.54 to 0.82
|
0.96 pg mAb/ng total protein
Interval 0.5 to 1.03
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 5
|
0.03 pg mAb/ng total protein
Interval 0.02 to 0.06
|
0.16 pg mAb/ng total protein
Interval 0.14 to 0.22
|
0.19 pg mAb/ng total protein
Interval 0.18 to 0.21
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 7
|
0.21 pg mAb/ng total protein
Interval 0.19 to 0.26
|
0.8 pg mAb/ng total protein
Interval 0.57 to 0.95
|
0.07 pg mAb/ng total protein
Interval 0.04 to 0.09
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 9
|
0.04 pg mAb/ng total protein
Interval 0.04 to 0.06
|
0.23 pg mAb/ng total protein
Interval 0.22 to 0.26
|
0.04 pg mAb/ng total protein
Interval 0.04 to 0.06
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 12
|
0.28 pg mAb/ng total protein
Interval 0.24 to 0.32
|
0.54 pg mAb/ng total protein
Interval 0.41 to 0.57
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 14
|
0.29 pg mAb/ng total protein
Interval 0.25 to 0.33
|
0.49 pg mAb/ng total protein
Interval 0.43 to 0.73
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 15
|
0.06 pg mAb/ng total protein
Interval 0.03 to 0.08
|
0.07 pg mAb/ng total protein
Interval 0.02 to 0.13
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 16
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
0.03 pg mAb/ng total protein
Interval 0.01 to 0.07
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Softcup Fluid-Female-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 2
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 4
|
—
|
—
|
0.86 pg mAb/ng total protein
Interval 0.59 to 1.1
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 5
|
—
|
—
|
0.25 pg mAb/ng total protein
Interval 0.14 to 0.31
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 9
|
—
|
—
|
0.03 pg mAb/ng total protein
Interval 0.02 to 0.04
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 12
|
—
|
—
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.02
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 14
|
0.21 pg mAb/ng total protein
Interval 0.14 to 0.32
|
0.76 pg mAb/ng total protein
Interval 0.7 to 0.82
|
0.01 pg mAb/ng total protein
Interval 0.0 to 0.02
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 15
|
0.04 pg mAb/ng total protein
Interval 0.03 to 0.05
|
0.11 pg mAb/ng total protein
Interval 0.07 to 0.14
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 16
|
0.01 pg mAb/ng total protein
Interval 0.01 to 0.01
|
0.02 pg mAb/ng total protein
Interval 0.01 to 0.05
|
—
|
—
|
—
|
—
|
|
Protein-normalized Levels of VRC01 in Genital and Rectal Secretions, as Well as Cervical, Vaginal, and Rectal Tissues (for Groups 1, 2, and 4)
Vaginal Biopsy Lysate-Female-Visit 17
|
0 pg mAb/ng total protein
Interval 0.0 to 0.0
|
0 pg mAb/ng total protein
Interval 0.0 to 0.01
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Cervical biopsies collected at visits 2 and 14; Rectal biopsies collected at visits 2, 14, 15, 16, 17, 18, 19 (19 not apply for Du422.1); Vaginal biopsies collected at visits 2 and 14, 15, 16, 17. RLU measured every 3 days, during culture days 3-21.Population: Visit schedule is not the same for each treatment group. For visits not on the schedule, number analyzed is 0 and median/IQR is ---.
Magnitudes of ex vivo HIV-1 infection were measured by the tissue luminescence assay (TLA). Susceptibility to viral infection in the ex vivo challenge assay is summarized by the area under the viral infectivity curve (AUC) based on log-transformed RLU values between 3-21 days of culture, indicated as AUCday3-21.
Outcome measures
| Measure |
Group 1: Vaccine
n=23 Participants
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 Participants
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 Participants
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Cervical Biopsy-Bal26-visit 2
|
134.61 Log(RLU)*Day
Interval 114.47 to 138.29
|
128.69 Log(RLU)*Day
Interval 120.23 to 132.74
|
125.66 Log(RLU)*Day
Interval 120.08 to 136.16
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Cervical Biopsy-Bal26-visit 14
|
81.74 Log(RLU)*Day
Interval 80.14 to 89.01
|
80.03 Log(RLU)*Day
Interval 78.51 to 80.27
|
82.33 Log(RLU)*Day
Interval 81.61 to 83.05
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-1086-visit 2
|
149.47 Log(RLU)*Day
Interval 145.48 to 152.04
|
151.28 Log(RLU)*Day
Interval 144.06 to 153.78
|
145.97 Log(RLU)*Day
Interval 134.13 to 150.66
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-1086-visit 14
|
147.95 Log(RLU)*Day
Interval 145.12 to 150.71
|
147.69 Log(RLU)*Day
Interval 141.98 to 151.35
|
152.22 Log(RLU)*Day
Interval 150.83 to 152.75
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-1086-visit 15
|
150.66 Log(RLU)*Day
Interval 143.88 to 158.18
|
148.86 Log(RLU)*Day
Interval 137.49 to 152.6
|
145.42 Log(RLU)*Day
Interval 139.31 to 147.3
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-1086-visit 16
|
147.24 Log(RLU)*Day
Interval 144.16 to 151.24
|
145.82 Log(RLU)*Day
Interval 142.66 to 151.74
|
153.31 Log(RLU)*Day
Interval 146.73 to 153.45
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-1086-visit 17
|
147.56 Log(RLU)*Day
Interval 138.79 to 150.2
|
148.37 Log(RLU)*Day
Interval 146.89 to 150.47
|
148.82 Log(RLU)*Day
Interval 136.03 to 154.05
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-1086-visit 18
|
—
|
—
|
139.29 Log(RLU)*Day
Interval 133.19 to 145.38
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-1086-visit 19
|
—
|
—
|
148.87 Log(RLU)*Day
Interval 148.87 to 148.87
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Bal26-visit 2
|
142.83 Log(RLU)*Day
Interval 139.27 to 144.63
|
139.99 Log(RLU)*Day
Interval 136.37 to 144.52
|
140.62 Log(RLU)*Day
Interval 140.35 to 140.69
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Bal26-visit 14
|
93.17 Log(RLU)*Day
Interval 90.26 to 96.57
|
97.41 Log(RLU)*Day
Interval 89.65 to 107.71
|
90.31 Log(RLU)*Day
Interval 88.38 to 91.73
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Bal26-visit 15
|
136.16 Log(RLU)*Day
Interval 107.58 to 144.78
|
117.51 Log(RLU)*Day
Interval 105.53 to 137.13
|
89.36 Log(RLU)*Day
Interval 88.87 to 97.36
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Bal26-visit 16
|
136.69 Log(RLU)*Day
Interval 130.48 to 142.45
|
135.71 Log(RLU)*Day
Interval 127.26 to 144.7
|
92.33 Log(RLU)*Day
Interval 88.39 to 114.91
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Bal26-visit 17
|
138.8 Log(RLU)*Day
Interval 135.35 to 143.92
|
140.59 Log(RLU)*Day
Interval 137.3 to 143.16
|
129.17 Log(RLU)*Day
Interval 105.55 to 140.14
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Bal26-visit 18
|
—
|
—
|
115.21 Log(RLU)*Day
Interval 91.07 to 139.34
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Bal26-visit 19
|
—
|
—
|
106.05 Log(RLU)*Day
Interval 106.05 to 106.05
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Du422.1-visit 2
|
141.44 Log(RLU)*Day
Interval 129.25 to 150.08
|
142.74 Log(RLU)*Day
Interval 127.52 to 145.48
|
151.14 Log(RLU)*Day
Interval 146.98 to 152.85
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Du422.1-visit 14
|
145.48 Log(RLU)*Day
Interval 137.7 to 155.83
|
138.99 Log(RLU)*Day
Interval 131.85 to 143.72
|
143.46 Log(RLU)*Day
Interval 129.24 to 151.88
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Du422.1-visit 15
|
141.14 Log(RLU)*Day
Interval 123.53 to 147.23
|
139.5 Log(RLU)*Day
Interval 123.33 to 148.93
|
145.45 Log(RLU)*Day
Interval 140.12 to 149.79
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Du422.1-visit 16
|
143.53 Log(RLU)*Day
Interval 139.83 to 147.13
|
142 Log(RLU)*Day
Interval 139.9 to 148.63
|
144.16 Log(RLU)*Day
Interval 138.03 to 149.44
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Du422.1-visit 17
|
145.72 Log(RLU)*Day
Interval 138.63 to 149.71
|
139.58 Log(RLU)*Day
Interval 133.97 to 145.52
|
150.64 Log(RLU)*Day
Interval 147.97 to 152.59
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Rectal Biopsy-Du422.1-visit 18
|
—
|
—
|
130.75 Log(RLU)*Day
Interval 130.75 to 130.75
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Vaginal Biopsy-Bal26-visit 2
|
128.69 Log(RLU)*Day
Interval 127.25 to 135.46
|
130.33 Log(RLU)*Day
Interval 122.46 to 140.45
|
116.62 Log(RLU)*Day
Interval 81.53 to 140.27
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Vaginal Biopsy-Bal26-visit 14
|
80.78 Log(RLU)*Day
Interval 78.33 to 88.97
|
82.89 Log(RLU)*Day
Interval 80.98 to 92.99
|
80.88 Log(RLU)*Day
Interval 79.45 to 82.32
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Vaginal Biopsy-Bal26-visit 15
|
94.41 Log(RLU)*Day
Interval 81.3 to 109.8
|
89.85 Log(RLU)*Day
Interval 81.33 to 105.55
|
82.26 Log(RLU)*Day
Interval 80.61 to 83.04
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Vaginal Biopsy-Bal26-visit 16
|
128.28 Log(RLU)*Day
Interval 118.47 to 132.88
|
104.97 Log(RLU)*Day
Interval 93.97 to 112.99
|
82.76 Log(RLU)*Day
Interval 79.37 to 83.01
|
—
|
—
|
—
|
|
Ex Vivo Inhibition of HIV-1 Infectivity in Tissue Biopsies (for Groups 1, 2, and 3)
Vaginal Biopsy-Bal26-visit 17
|
131.37 Log(RLU)*Day
Interval 131.37 to 131.37
|
137.49 Log(RLU)*Day
Interval 130.71 to 144.27
|
—
|
—
|
—
|
—
|
Adverse Events
Group 1: Vaccine
Serious events: 0 serious events
Other events: 22 other events
Deaths: 0 deaths
Group 2: Vaccine
Serious events: 1 serious events
Other events: 18 other events
Deaths: 0 deaths
Group 3: Vaccine
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 4: Vaccine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 5: Vaccine
Serious events: 1 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 6: Pre-treatment
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Vaccine
n=23 participants at risk
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 participants at risk
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 participants at risk
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 participants at risk
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 participants at risk
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 participants at risk
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Blood and lymphatic system disorders
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Blood and lymphatic system disorders
Blood loss anaemia
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Appendicitis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Nervous system disorders
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Nervous system disorders
Transient ischaemic attack
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
Other adverse events
| Measure |
Group 1: Vaccine
n=23 participants at risk
VRC01 10 mg/kg mo(0,2,4,6)
|
Group 2: Vaccine
n=23 participants at risk
VRC01 30 mg/kg mo(0,2,4,6)
|
Group 3: Vaccine
n=7 participants at risk
VRC01LS 30 mg/kg mo(0,3,6)
|
Group 4: Vaccine
n=16 participants at risk
VRC01 30 mg/kg mo(0)
|
Group 5: Vaccine
n=10 participants at risk
VRC01LS 30 mg/kg mo(0)
|
Group 6: Pre-treatment
n=1 participants at risk
Biopsy collected but was not randomized to any treatment group
|
|---|---|---|---|---|---|---|
|
Gastrointestinal disorders
Anal haemorrhage
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Anal pruritus
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Anorectal discomfort
|
4.3%
1/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Constipation
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Dental caries
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
13.0%
3/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Dyschezia
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Dyspepsia
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Food poisoning
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Gastritis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Abdominal pain
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Abdominal pain upper
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Ear and labyrinth disorders
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Eye disorders
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Eye disorders
Vitreous floaters
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Any Event in SOC
|
30.4%
7/23 • Number of events 10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
26.1%
6/23 • Number of events 13 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
28.6%
2/7 • Number of events 6 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
28.6%
2/7 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Tendonitis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cystadenofibroma of fallopian tube
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Nervous system disorders
Any Event in SOC
|
21.7%
5/23 • Number of events 5 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
21.7%
5/23 • Number of events 7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Nervous system disorders
Dizziness
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Irritable bowel syndrome
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Rectal haemorrhage
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Nervous system disorders
Headache
|
13.0%
3/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Gastrointestinal disorders
Toothache
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
General disorders
Any Event in SOC
|
8.7%
2/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
General disorders
Chest discomfort
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
General disorders
Fatigue
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
General disorders
Influenza like illness
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
General disorders
Injury associated with device
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Any Event in SOC
|
69.6%
16/23 • Number of events 37 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
73.9%
17/23 • Number of events 31 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
100.0%
7/7 • Number of events 12 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
12.5%
2/16 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Abscess limb
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Acarodermatitis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Bacterial vaginosis
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Body tinea
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Candida cervicitis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Candida infection
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Cellulitis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Conjunctivitis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Dysentery
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Folliculitis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Gastroenteritis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Gastroenteritis norovirus
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Genitourinary chlamydia infection
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Gingivitis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Haemorrhoid infection
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Impetigo
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Laryngitis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Localised infection
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Lower respiratory tract infection
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Oral herpes
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Pharyngitis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Post procedural infection
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Rhinitis
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Sinusitis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Subcutaneous abscess
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Tinea capitis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Tinea pedis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Tinea versicolour
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Upper respiratory tract infection
|
39.1%
9/23 • Number of events 13 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
39.1%
9/23 • Number of events 15 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
42.9%
3/7 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Urinary tract infection
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Viral upper respiratory tract infection
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
13.0%
3/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Vulvovaginal candidiasis
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Infections and infestations
Vulvovaginal mycotic infection
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Nervous system disorders
Presyncope
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
30.4%
7/23 • Number of events 8 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
13.0%
3/23 • Number of events 6 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
12.5%
2/16 • Number of events 4 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Infusion related reaction
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Neck injury
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Procedural dizziness
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Procedural nausea
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Injury, poisoning and procedural complications
Skin laceration
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Any Event in SOC
|
39.1%
9/23 • Number of events 22 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
43.5%
10/23 • Number of events 16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
42.9%
3/7 • Number of events 8 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
12.5%
2/16 • Number of events 5 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Alanine aminotransferase increased
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
13.0%
3/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Blood alkaline phosphatase increased
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Blood creatinine increased
|
13.0%
3/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
21.7%
5/23 • Number of events 6 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Blood pressure increased
|
26.1%
6/23 • Number of events 11 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
13.0%
3/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
28.6%
2/7 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Haemoglobin decreased
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Neutrophil count decreased
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Platelet count decreased
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
Vitamin D decreased
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Investigations
White blood cell count decreased
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Metabolism and nutrition disorders
Any Event in SOC
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Metabolism and nutrition disorders
Decreased appetite
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
26.1%
6/23 • Number of events 7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
13.0%
3/23 • Number of events 4 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
42.9%
3/7 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Flank pain
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Nervous system disorders
Restless legs syndrome
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Nervous system disorders
Tension headache
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Pregnancy, puerperium and perinatal conditions
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Pregnancy, puerperium and perinatal conditions
Ectopic pregnancy
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Psychiatric disorders
Any Event in SOC
|
13.0%
3/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Psychiatric disorders
Anxiety
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Psychiatric disorders
Post-traumatic stress disorder
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Renal and urinary disorders
Any Event in SOC
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Renal and urinary disorders
Glycosuria
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Any Event in SOC
|
26.1%
6/23 • Number of events 13 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Adenomyosis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Breast mass
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Menstruation irregular
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Vaginal haemorrhage
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Vulva cyst
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Vulvovaginal discomfort
|
8.7%
2/23 • Number of events 7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Reproductive system and breast disorders
Vulvovaginal pruritus
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Respiratory, thoracic and mediastinal disorders
Paranasal sinus discomfort
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
6.2%
1/16 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Any Event in SOC
|
26.1%
6/23 • Number of events 9 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
17.4%
4/23 • Number of events 5 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
28.6%
2/7 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Dermatitis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
8.7%
2/23 • Number of events 3 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Eczema
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Macule
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Papule
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Rash pruritic
|
8.7%
2/23 • Number of events 2 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Skin ulcer
|
4.3%
1/23 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
14.3%
1/7 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Vascular disorders
Any Event in SOC
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
100.0%
1/1 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Vascular disorders
Hot flush
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
10.0%
1/10 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
|
Vascular disorders
Thrombophlebitis
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/23 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/7 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/16 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
0.00%
0/10 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
100.0%
1/1 • Number of events 1 • Measured through participant's last study visit, at 6 months to 1 1/2 years after study entry (depending on which group participants are in)
|
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