Trial Outcomes & Findings for A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults (NCT NCT05627258)
NCT ID: NCT05627258
Last Updated: 2025-08-22
Results Overview
New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 24 for Groups 1-4 and through Week 48 for Groups 5-6. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
23 participants
Primary outcome timeframe
Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48 for Groups 5-6
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Group 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing, 3 times 12 weeks apart
|
Group 6
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing, 3 times 12 weeks apart
|
|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
4
|
3
|
3
|
3
|
5
|
5
|
|
Overall Study
Completed Product Administration
|
3
|
3
|
3
|
3
|
2
|
3
|
|
Overall Study
COMPLETED
|
1
|
3
|
2
|
3
|
3
|
5
|
|
Overall Study
NOT COMPLETED
|
3
|
0
|
1
|
0
|
2
|
0
|
Reasons for withdrawal
| Measure |
Group 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing, 3 times 12 weeks apart
|
Group 6
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing, 3 times 12 weeks apart
|
|---|---|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Withdrawal by Subject
|
0
|
0
|
0
|
0
|
2
|
0
|
|
Overall Study
Enrolled, but product not administered
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Other subject illness/injury
|
1
|
0
|
0
|
0
|
0
|
0
|
|
Overall Study
Subject moved from area
|
0
|
0
|
1
|
0
|
0
|
0
|
Baseline Characteristics
A Study of the Safety and Pharmacokinetics of a Human Monoclonal Antibody, VRCHIVMAB0115-00-AB (VRC01.23LS), Administered Intravenously or Subcutaneously to Healthy Adults
Baseline characteristics by cohort
| Measure |
Group 1
n=4 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS- 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing:3 times, 12 weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times, 12 weeks apart
|
Total
n=23 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
28.3 years
STANDARD_DEVIATION 3.2 • n=5 Participants
|
44.3 years
STANDARD_DEVIATION 7.1 • n=7 Participants
|
21.3 years
STANDARD_DEVIATION 0.6 • n=5 Participants
|
28.7 years
STANDARD_DEVIATION 12.2 • n=4 Participants
|
26.2 years
STANDARD_DEVIATION 4.3 • n=21 Participants
|
29.6 years
STANDARD_DEVIATION 5.6 • n=8 Participants
|
29.3 years
STANDARD_DEVIATION 8.4 • n=8 Participants
|
|
Age, Customized
AGE · Ages 18-20
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Age, Customized
AGE · Ages 21-30
|
3 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
4 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Age, Customized
AGE · Ages 31-40
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
6 Participants
n=8 Participants
|
|
Age, Customized
AGE · Ages 41-60
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
11 Participants
n=8 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
12 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
3 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
5 Participants
n=21 Participants
|
5 Participants
n=8 Participants
|
19 Participants
n=8 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
1 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
3 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=8 Participants
|
4 Participants
n=8 Participants
|
|
Race (NIH/OMB)
White
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
4 Participants
n=8 Participants
|
13 Participants
n=8 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Weight
|
68.0 kg
STANDARD_DEVIATION 16.8 • n=5 Participants
|
82.9 kg
STANDARD_DEVIATION 11.4 • n=7 Participants
|
66.7 kg
STANDARD_DEVIATION 11.7 • n=5 Participants
|
75.2 kg
STANDARD_DEVIATION 18.3 • n=4 Participants
|
81.7 kg
STANDARD_DEVIATION 26.9 • n=21 Participants
|
68.6 kg
STANDARD_DEVIATION 11.00 • n=8 Participants
|
73.8 kg
STANDARD_DEVIATION 17.1 • n=8 Participants
|
|
Education
Less than a high school graduate
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
|
Education
High school graduate/GED
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
2 Participants
n=8 Participants
|
|
Education
College/University
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
3 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
|
Education
Advanced degree
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=8 Participants
|
5 Participants
n=8 Participants
|
|
Education
Not Collected
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=8 Participants
|
0 Participants
n=8 Participants
|
PRIMARY outcome
Timeframe: 7 days after product administrationPopulation: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.
Participants recorded the occurrence of solicited local symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Local Symptom" is the number of participants reporting any local symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017)
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Mild
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · None
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pain/Tenderness · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · None
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritus · None
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Swelling · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · None
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritus · Mild
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritus · Moderate
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Pruritus · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · None
|
3 Participants
|
3 Participants
|
1 Participants
|
3 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Mild
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Bruising · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · None
|
3 Participants
|
1 Participants
|
1 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Mild
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Local Symptom · Severe
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Redness · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 7 days after product administrationPopulation: Population included all enrolled participants who received study product and provided safety data (via diary card and/or laboratory results) following vaccine administration (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.
Participants recorded the occurrence of solicited systemic symptoms on a diary card for 7 days after study product administration and reviewed the diary card with clinic staff at a follow up visit. Participants were counted once for each symptom at the worst severity if they indicated experiencing the symptom more than one time at any severity during the reporting period. The number reported for "Any Systemic Symptom" is the number of participants reporting any systemic symptom at the worst severity. Reactogenicity grading (Mild, Moderate, Severe) was done using the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events (Corrected Version 2.1 - July 2017
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · None
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Malaise · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · None
|
2 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Myalgia · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · None
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
2 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Headache · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · None
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Chills · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · None
|
2 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
3 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Nausea · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Temperature · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · None
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Mild
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Joint Pain · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · None
|
2 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
1 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Mild
|
1 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
2 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Moderate
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
1 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms Within 7 Days of Product Administration
Any Systemic Symptom · Severe
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 168, up to Week 24 for participants in Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for participants in Group 5 and 6.Population: Population included all enrolled participants who received study product (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.
SAEs were recorded from receipt of product administration through the last study visit at Week 24 for participants in Groups 1, 2, 3, 4. SAEs were recorded from receipt of product administration through the last study visit at Week 48 for participants in Groups 5 or 6. The relationship between a SAE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Serious Adverse Events Following Product Administration
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events Following Product Administration
Unrelated to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events Following Product Administration
Total Number of Participants who had SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Serious Adverse Events Following Product Administration
Total number of Participants who did not have SAE
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 through 28 days post product administration, up to Week 4Population: Population included all enrolled participants who received study product (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.
Unsolicited AEs and attribution assessments were recorded in the study database from receipt of study product administration through the visit scheduled for 4 weeks after study product administration. At other time periods greater than 4 weeks after the study product administration, only serious AEs (SAEs reported as a separate outcome and in the AE module) and new chronic medical conditions were recorded through the last study visit. The relationship between an AE and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Related to Study Product
|
0 participants
|
0 participants
|
1 participants
|
3 participants
|
2 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Unrelated to Study Product
|
0 participants
|
0 participants
|
1 participants
|
0 participants
|
1 participants
|
0 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Total Number of Participants who had One or More Non-Serious Unsolicited AE
|
0 participants
|
0 participants
|
2 participants
|
3 participants
|
3 participants
|
2 participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With One or More Unsolicited Non-Serious Adverse Events (AEs) Following Product Administration
Total Number of Participants who had no Unsolicited AEs
|
3 participants
|
3 participants
|
1 participants
|
0 participants
|
2 participants
|
3 participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48 for Groups 5-6Population: Population included all enrolled participants who received study product (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.
New chronic medical conditions that required ongoing medical management were recorded from receipt of study product administration through the last expected study visit at Week 24 for Groups 1-4 and through Week 48 for Groups 5-6. The relationship between a new chronic medical condition and the study product was assessed by the investigator based on clinical judgment and the definitions outlined in the protocol. A participant with multiple experiences of the same event is counted once using the event of worst severity.
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Related to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Unrelated to Study Product
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Number of Participants With New Chronic Medical Condition
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With New Chronic Medical Conditions Following Product Administration
Number of Participants With No New Chronic Medical Condition
|
3 Participants
|
3 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: Day 0 after product administration through Day 140, up to Week 24 for Groups 1-4. Day 0 after product administration through Day 336, up to Week 48, for Groups 5-6Population: Population included all enrolled participants who received study product (N=22). One participant in Group 1 did not receive study product due to onset of a panic attack after IV insertion.
Abnormal lab results recorded as unsolicited adverse events (AEs) are summarized. Safety lab parameters included pregnancy test, hematology and chemistry labs, and HIV Serology diagnostic test. Institutional lab normal ranges as well as the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 - July 2017 were used.
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Bilirubin
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Creatinine
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
—
|
—
|
—
|
—
|
|
Number of Participants With Abnormal Laboratory Measures of Safety Following Product Administration
Number of Participants With No Abnormal lab results recorded as unsolicited adverse events (AEs)
|
3 Participants
|
3 Participants
|
3 Participants
|
2 Participants
|
4 Participants
|
5 Participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after VRC01.23LS product administrationCmax is the peak serum concentration that VRC01.23LS achieves after it has been administered; it is determined as a maximum value on the summary pharmacokinetic (PK) curve for each study group.
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
n=2 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of VRC01.23LS: Maximum Observed Serum Concentration (Cmax)
|
96.4 mcg/mL
Standard Deviation 9.7
|
13.4 mcg/mL
Standard Deviation 3.9
|
343.5 mcg/mL
Standard Deviation 51.7
|
719.8 mcg/mL
Standard Deviation 109.7
|
14.1 mcg/mL
Standard Deviation 5.4
|
12.9 mcg/mL
Standard Deviation 5.1
|
19 mcg/mL
Standard Deviation 5.9
|
428 mcg/mL
Standard Deviation 60.9
|
491 mcg/mL
Standard Deviation 61
|
437 mcg/mL
Standard Deviation 85
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after VRC01.23LS product administrationTmax is the time it takes to reach Cmax of VRC01.23LS after it has been administered; it is determined based on the summary PK curve for each dose group.
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
n=2 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of VRC01.23LS: Time to Reach Maximum Observed Serum Concentration (Tmax)
|
0.024 days
Standard Deviation 0.003
|
2.9 days
Standard Deviation 0.011
|
0.024 days
Standard Deviation 0.001
|
0.042 days
Standard Deviation 0.019
|
2.7 days
Standard Deviation 0.42
|
2.9 days
Standard Deviation 0
|
4 days
Standard Deviation 1.4
|
0.023 days
Standard Deviation 0.001
|
0.032 days
Standard Deviation 0.021
|
0.039 days
Standard Deviation 0.013
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after VRC01.23LS product administrationBeta half-life (T1/2b) is the time required for half of the VRC01.23LS product to be eliminated from the serum.
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of VRC01.23LS: Beta Half-life (T1/2b)
|
27.2 days
Standard Deviation 1.8
|
43.3 days
Standard Deviation 9.8
|
51.4 days
Standard Deviation 3.2
|
53.6 days
Standard Deviation 4.3
|
53.3 days
Standard Deviation 26.9
|
40.9 days
Standard Deviation 4
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after VRC01.23LS product administrationClearance is the rate of VRC01.23LS elimination divided by the plasma VRC01.23LS concentration; determined based on the summary pharmacokinetic (PK) curve for each study group. Clearance following a SC administration is calculated as Clearance (CL)/Bioavailability (F).
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of VRC01.23LS: Clearance Rate
|
395.6 mL/day
Standard Deviation 61.6
|
667.5 mL/day
Standard Deviation 43.8
|
478.2 mL/day
Standard Deviation 81.1
|
504.4 mL/day
Standard Deviation 94.1
|
688 mL/day
Standard Deviation 255.9
|
458.1 mL/day
Standard Deviation 88.2
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline through 24 weeks after VRC01.23LS product administrationTheoretical volume that would be necessary to contain the total amount of administered drug at the same concentration as observed in plasma. It represents the degree to which a drug is distributed in body tissue rather than the plasma and calculated based in the PK curve for each study group. Volume of distribution following a SC administration is calculated as Volume of distribution (V)/Bioavailability (F).
Outcome measures
| Measure |
Group 1
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS -5 mg/kg SC repeat dosing: 3 times 12, weeks apart
|
Group 6
n=5 Participants
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times 12, weeks apart
|
Group 5/ Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing
|
Group 6/Dose 1
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 2
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
Group 6/Dose 3
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Pharmacokinetic (PK) Parameters of VRC01.23LS: Volume of Distribution
|
14.7 L
Standard Deviation 1.6
|
38.2 L
Standard Deviation 6.9
|
32.3 L
Standard Deviation 3.7
|
35.6 L
Standard Deviation 4.2
|
44.7 L
Standard Deviation 40.7
|
24.7 L
Standard Deviation 3.9
|
—
|
—
|
—
|
—
|
Adverse Events
Group 1
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
Group 2
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Group 3
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 4
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Group 5
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Group 6
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Group 1
n=3 participants at risk
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg IV single administration
|
Group 2
n=3 participants at risk
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC single administration
|
Group 3
n=3 participants at risk
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV single administration
|
Group 4
n=3 participants at risk
VRC-HIVMAB0115-00-AB: VRC01.23LS - 40 mg/kg IV single administration
|
Group 5
n=5 participants at risk
VRC-HIVMAB0115-00-AB: VRC01.23LS - 5 mg/kg SC repeat dosing: 3 times, 12 weeks apart
|
Group 6
n=5 participants at risk
VRC-HIVMAB0115-00-AB: VRC01.23LS - 20 mg/kg IV repeat dosing: 3 times, 12 weeks apart
|
|---|---|---|---|---|---|---|
|
Cardiac disorders
Palpitations
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
100.0%
3/3 • Number of events 3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
2/5 • Number of events 4 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Respiratory, thoracic and mediastinal disorders
Upper Respiratory Tract Infection
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Chest Discomfort
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Hepatobiliary disorders
Hyperbilirubinemia
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Renal and urinary disorders
Dysuria
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Renal and urinary disorders
Urinary Tract Infection
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Viral Infection
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Malaise
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
60.0%
3/5 • Number of events 6 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
2/5 • Number of events 12 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
60.0%
3/5 • Number of events 5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 2 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Nervous system disorders
Headache
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
60.0%
3/5 • Number of events 7 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
2/5 • Number of events 4 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Chills
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 2 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
2/5 • Number of events 3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
Gastrointestinal disorders
Nausea
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
2/5 • Number of events 3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site pain
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 2 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
2/5 • Number of events 8 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site swelling
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site erythema
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 4 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
2/5 • Number of events 3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site prurituis
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
33.3%
1/3 • Number of events 1 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
40.0%
2/5 • Number of events 2 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
|
General disorders
Administration site bruising
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
66.7%
2/3 • Number of events 14 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/3 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
20.0%
1/5 • Number of events 4 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
0.00%
0/5 • Solicited adverse events (AEs) were reported for 7 days after product administration. Unsolicited AEs were reported for 4 weeks after study product administration. Serious AEs and new chronic medical conditions were reported through last study visit (up to Week 24 for Groups 1-4 and up to 48 weeks for Groups 5 and 6).
The overall Arms/Groups summarize AEs collected after product administration separately and grouped by the study product and dose. Solicited AEs collected through systematic assessment and unsolicited AEs collected through non-systematic assessment represent the number and percentage of participants reporting the event. A participant with multiple experiences of the same event is counted once using the event of worst severity. Influenza/ILI were collected separately and not included as AE.
|
Additional Information
Lesia K. Dropulic, M.D./Principal Investigator; Laura Novik, R.N., M.A./Study Coordinator
Vaccine Research Center Clinical Trials Program, NIAID
Phone: 301-451-8717
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place