Trial Outcomes & Findings for A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells (NCT NCT03856996)
NCT ID: NCT03856996
Last Updated: 2024-07-12
Results Overview
Graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Recruitment status
COMPLETED
Study phase
PHASE1
Target enrollment
30 participants
Primary outcome timeframe
Measured through 7 days after each vaccine dose
Results posted on
2024-07-12
Participant Flow
Participant milestones
| Measure |
Group 1: Vaccine
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Overall Study
STARTED
|
15
|
15
|
|
Overall Study
COMPLETED
|
12
|
13
|
|
Overall Study
NOT COMPLETED
|
3
|
2
|
Reasons for withdrawal
| Measure |
Group 1: Vaccine
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
1
|
|
Overall Study
Adverse Event
|
1
|
1
|
|
Overall Study
Other
|
1
|
0
|
Baseline Characteristics
A Clinical Trial in Healthy, HIV-1-Uninfected Adult Participants to Compare the Safety, Tolerability and Immunogenicity of CH505TF gp120 Produced From Stably Transfected Cells to CH505TF gp120 Produced From Transiently Transfected Cells
Baseline characteristics by cohort
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
Total
n=30 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28 years
n=5 Participants
|
28 years
n=7 Participants
|
28 years
n=5 Participants
|
|
Age, Customized
Less than 18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
18 - 20 years
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Age, Customized
21 - 30 years
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Age, Customized
31 - 40 years
|
3 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Age, Customized
41 - 50 years
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Age, Customized
Above 50 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Customized
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
8 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
14 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
15 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine doseGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
None
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Mild
|
9 Participants
|
12 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Moderate
|
4 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Pain and/or Tenderness
Potentially Life-threatening
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine doseGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · None
|
12 Participants
|
15 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Not gradable
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 2: 5 to less than 10 cm dim.
|
3 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 3: >= 10cm dim.
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 3: complications AE
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema/Redness · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · None
|
14 Participants
|
14 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Not gradable
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 2: 5 to less than 10 cm dim.
|
1 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 3: >= 10cm dim.
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 3: complications AE
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Induration/Swelling · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · None
|
12 Participants
|
14 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Not gradable
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 1: 2.5 to less than 5 cm dim.
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 2: 5 to less than 10 cm dim.
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: >= 10cm dim.
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 3: complications AE
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Local Reactogenicity Signs and Symptoms: Erythema and/or Induration
Erythema and/or Induration · Gr 4: complications AE
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured through 7 days after each vaccine doseGraded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 2.1 \[July 2017\]. The maximum grade observed for each symptom over the time frame is presented.
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · None
|
9 Participants
|
9 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Mild
|
4 Participants
|
4 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Moderate
|
2 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Headache · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · None
|
13 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Mild
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · None
|
9 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Mild
|
3 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Moderate
|
3 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Malaise and/or fatigue · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · None
|
12 Participants
|
11 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Mild
|
1 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Moderate
|
2 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Myalgia · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Nausea · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · None
|
13 Participants
|
14 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Mild
|
2 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Moderate
|
0 Participants
|
1 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Chills · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · None
|
13 Participants
|
13 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Mild
|
1 Participants
|
2 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Arthralgia · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · None
|
6 Participants
|
5 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Mild
|
5 Participants
|
7 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Moderate
|
4 Participants
|
3 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Max. Systemic Symptoms · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · None
|
14 Participants
|
15 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Mild
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Moderate
|
1 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Severe
|
0 Participants
|
0 Participants
|
|
Number of Participants Reporting Systemic Reactogenicity Signs and Symptoms
Temperature · Potentially Life-threatening
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182, 273Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alanine Aminotransferase -Baseline
|
22 U/L
Interval 17.0 to 31.0
|
19 U/L
Interval 14.0 to 25.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alanine Aminotransferase -Day 14
|
20 U/L
Interval 13.0 to 26.0
|
17 U/L
Interval 10.0 to 21.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alanine Aminotransferase -Day 70
|
18.5 U/L
Interval 15.5 to 29.0
|
18 U/L
Interval 12.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alanine Aminotransferase -Day 182
|
17 U/L
Interval 14.0 to 20.0
|
18.5 U/L
Interval 12.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alanine Aminotransferase -Day 273
|
17 U/L
Interval 11.0 to 21.0
|
19 U/L
Interval 16.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Aspartate Aminotransferase -Baseline
|
25 U/L
Interval 19.0 to 27.0
|
19 U/L
Interval 14.0 to 22.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Aspartate Aminotransferase -Day 14
|
18 U/L
Interval 16.0 to 23.0
|
18 U/L
Interval 12.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Aspartate Aminotransferase -Day 70
|
18 U/L
Interval 15.0 to 34.0
|
21 U/L
Interval 16.0 to 24.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Aspartate Aminotransferase -Day 182
|
16 U/L
Interval 13.0 to 24.0
|
21.5 U/L
Interval 16.0 to 23.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Aspartate Aminotransferase -Day 273
|
16 U/L
Interval 14.0 to 23.0
|
24 U/L
Interval 17.0 to 28.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alkaline Phosphatase -Baseline
|
61 U/L
Interval 49.0 to 75.0
|
60 U/L
Interval 50.0 to 67.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alkaline Phosphatase -Day 14
|
58 U/L
Interval 54.0 to 76.0
|
60 U/L
Interval 51.0 to 63.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alkaline Phosphatase -Day 70
|
64 U/L
Interval 55.5 to 69.5
|
61 U/L
Interval 56.0 to 63.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alkaline Phosphatase -Day 182
|
61 U/L
Interval 51.0 to 67.0
|
64 U/L
Interval 51.0 to 69.0
|
|
Chemistry and Hematology Laboratory Measures - Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Alkaline Phosphatase (ALP) in U/L
Alkaline Phosphatase -Day 273
|
63 U/L
Interval 57.0 to 74.0
|
60 U/L
Interval 52.0 to 68.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182, 273Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine -Baseline
|
0.91 mg/dL
Interval 0.8 to 0.98
|
0.79 mg/dL
Interval 0.74 to 0.99
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine -Day 14
|
0.89 mg/dL
Interval 0.8 to 0.98
|
0.88 mg/dL
Interval 0.74 to 0.99
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine -Day 70
|
0.87 mg/dL
Interval 0.8 to 0.94
|
0.84 mg/dL
Interval 0.81 to 1.04
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine -Day 182
|
0.88 mg/dL
Interval 0.86 to 0.97
|
0.82 mg/dL
Interval 0.71 to 0.96
|
|
Chemistry and Hematology Laboratory Measures - Creatinine in mg/dL
Creatinine -Day 273
|
0.91 mg/dL
Interval 0.85 to 0.98
|
0.85 mg/dL
Interval 0.74 to 1.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182, 273Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin -Baseline
|
14 g/dL
Interval 13.0 to 16.0
|
14 g/dL
Interval 13.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin -Day 14
|
13 g/dL
Interval 12.0 to 15.0
|
13 g/dL
Interval 12.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin -Day 70
|
14 g/dL
Interval 13.0 to 16.0
|
14 g/dL
Interval 12.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin -Day 182
|
14 g/dL
Interval 13.0 to 16.0
|
14 g/dL
Interval 13.0 to 15.0
|
|
Chemistry and Hematology Laboratory Measures - Hemoglobin in g/dL
Hemoglobin -Day 273
|
15 g/dL
Interval 13.0 to 15.0
|
14 g/dL
Interval 13.0 to 15.0
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182, 273Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
For each local laboratory measure, summary statistics were presented by treatment group and timepoint for the overall population.
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
WBC -Baseline
|
6.3 1000 cells/cubic mm
Interval 5.4 to 8.1
|
6.6 1000 cells/cubic mm
Interval 6.3 to 7.8
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
WBC -Day 14
|
6.3 1000 cells/cubic mm
Interval 5.4 to 7.2
|
6.2 1000 cells/cubic mm
Interval 5.2 to 7.6
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
WBC -Day 70
|
6.4 1000 cells/cubic mm
Interval 5.45 to 7.0
|
6.3 1000 cells/cubic mm
Interval 4.9 to 7.2
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
WBC -Day 182
|
6.8 1000 cells/cubic mm
Interval 5.2 to 7.3
|
6.4 1000 cells/cubic mm
Interval 5.3 to 7.9
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
WBC -Day 273
|
6.2 1000 cells/cubic mm
Interval 5.6 to 7.4
|
6.3 1000 cells/cubic mm
Interval 5.5 to 7.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Platelets -Baseline
|
238 1000 cells/cubic mm
Interval 220.0 to 316.0
|
268 1000 cells/cubic mm
Interval 230.0 to 332.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Platelets -Day 14
|
257 1000 cells/cubic mm
Interval 220.0 to 313.0
|
267 1000 cells/cubic mm
Interval 241.0 to 352.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Platelets -Day 70
|
238 1000 cells/cubic mm
Interval 214.0 to 328.5
|
262 1000 cells/cubic mm
Interval 227.0 to 351.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Platelets -Day 182
|
243 1000 cells/cubic mm
Interval 221.0 to 311.0
|
267.5 1000 cells/cubic mm
Interval 232.0 to 347.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Platelets -Day 273
|
238 1000 cells/cubic mm
Interval 205.0 to 323.0
|
265 1000 cells/cubic mm
Interval 236.0 to 290.0
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Lymphocytes -Baseline
|
2.128 1000 cells/cubic mm
Interval 1.687 to 2.3
|
2.2 1000 cells/cubic mm
Interval 1.65 to 2.411
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Lymphocytes -Day 14
|
1.84 1000 cells/cubic mm
Interval 1.39 to 2.118
|
1.98 1000 cells/cubic mm
Interval 1.59 to 2.461
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Lymphocytes -Day 70
|
1.981 1000 cells/cubic mm
Interval 1.619 to 2.317
|
1.91 1000 cells/cubic mm
Interval 1.553 to 2.221
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Lymphocytes -Day 182
|
2.06 1000 cells/cubic mm
Interval 1.7 to 2.55
|
1.874 1000 cells/cubic mm
Interval 1.717 to 2.14
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Lymphocytes -Day 273
|
2.07 1000 cells/cubic mm
Interval 1.879 to 2.198
|
1.729 1000 cells/cubic mm
Interval 1.52 to 1.96
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Neutrophils -Baseline
|
3.74 1000 cells/cubic mm
Interval 2.81 to 5.06
|
3.713 1000 cells/cubic mm
Interval 3.237 to 4.53
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Neutrophils -Day 14
|
3.631 1000 cells/cubic mm
Interval 2.917 to 4.26
|
3.93 1000 cells/cubic mm
Interval 2.746 to 5.1
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Neutrophils -Day 70
|
3.503 1000 cells/cubic mm
Interval 2.923 to 4.32
|
3.437 1000 cells/cubic mm
Interval 2.81 to 4.498
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Neutrophils -Day 182
|
3.623 1000 cells/cubic mm
Interval 2.774 to 4.44
|
3.582 1000 cells/cubic mm
Interval 2.825 to 4.684
|
|
Chemistry and Hematology Laboratory Measures - Lymphocyte Count, Neutrophil Count, Platelets, WBC in 1000 Cells/Cubic mm
Neutrophils -Day 273
|
3.329 1000 cells/cubic mm
Interval 2.915 to 5.11
|
3.6 1000 cells/cubic mm
Interval 3.39 to 4.445
|
PRIMARY outcome
Timeframe: Measured during screening, Days 14, 70, 182, 273Population: Overall Number of Participants Analyzed represents participants enrolled and eligible for laboratory assessment. Participants do not have laboratory assessments if they attended the visit but laboratory specimens were not collected, missed the scheduled visit, or terminated participation in the study prior to the scheduled visit.
The number (percentage) of participants with lab grade \> 1 for alanine aminotransferase (ALT), aspartate aminotransferase (AST), alkaline phosphatase (ALP), creatinine, hemoglobin, lymphocyte count, neutrophil count, platelets, white blood cells (WBC) was summarized by arm
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alanine Aminotransferase (U/L)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alanine Aminotransferase (U/L)-Day 273
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Aspartate Aminotransferase (U/L)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Aspartate Aminotransferase (U/L)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Aspartate Aminotransferase (U/L)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Aspartate Aminotransferase (U/L)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Aspartate Aminotransferase (U/L)-Day 273
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alkaline Phosphatase (U/L)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alkaline Phosphatase (U/L)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alkaline Phosphatase (U/L)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alkaline Phosphatase (U/L)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Alkaline Phosphatase (U/L)-Day 273
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Hemoglobin (g/dL)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Hemoglobin (g/dL)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Hemoglobin (g/dL)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Hemoglobin (g/dL)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Hemoglobin (g/dL)-Day 273
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Creatinine (mg/dL)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Creatinine (mg/dL)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Creatinine (mg/dL)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Creatinine (mg/dL)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Creatinine (mg/dL)-Day 273
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
WBC (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
WBC (1000 cells/cubic mm)-Day 273
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Platelets (1000 cells/cubic mm)-Day 273
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Lymphocytes (1000 cells/cubic mm)-Day 273
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Baseline
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 14
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 70
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 182
|
0 Participants
|
0 Participants
|
|
The Number (Percentage) of Participants With Lab Grade > 1 for ALT, AST, ALP, Creatinine, Hemoglobin, Lymphocyte Count, Neutrophil Count, Platelets, WBC Was Summarized by Arm
Neutrophils (1000 cells/cubic mm)-Day 273
|
0 Participants
|
0 Participants
|
PRIMARY outcome
Timeframe: Adverse Events of Special Interest (AESI) health contact is at month 18AEs of special interest (AESI) for this protocol include but are not limited to potential immune-mediated diseases. AESI are reported regardless of relationship to study product(s). All AEs are graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, Corrected Version 2.1, July 2017.
Outcome measures
| Measure |
Group 1: Vaccine
n=15 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=15 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Adverse Events of Special Interest (AESIs)
Y
|
0 Participants
|
1 Participants
|
|
Adverse Events of Special Interest (AESIs)
N
|
15 Participants
|
14 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall number of participants analyzed" represents the HIV uninfected participants with available BAMA data at Month 6.5. "Number Analyzed" shows the number of positive responders with available BAMA data after filtering for assay specific quality control criteria at Month 6.5.
Serum HIV-1 specific IgG responses were measured on a BioPlex instrument using a standardized custom HIV1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI). Samples were titrated for IgG to CH505TF gp120 (transient transfection) and CH505TF gp120 (stable transfection) at month 0 (Visit 2) and month 6.5 (Visit 7), with a starting 1:50 dilution followed by a 5-fold dilution series. Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) the net MFI (MFI minus Blank) values were ≥ antigen-specific cutoff at the 1:50 dilution level for IgG, (2) the net MFI values were greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values were greater than 3 times the baseline MFI values.
Outcome measures
| Measure |
Group 1: Vaccine
n=13 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=14 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Occurrence of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins
CH505TF gp120 Stable
|
12 Participants
|
13 Participants
|
|
Occurrence of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins
CH505TF gp120 Transient
|
12 Participants
|
13 Participants
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall number of participants analyzed" represents the number of participants with positive total IgG Binding Antibody responses at Month 6.5. "Number Analyzed" shows the number of participants with positive total IgG Binding Antibody responses after filtering for assay specific quality control criteria at Month 6.5.
Serum HIV-1 specific IgG responses were measured on a BioPlex instrument using a standardized custom HIV1 Luminex assay. The readout was background-subtracted mean fluorescence intensity (MFI), where background referred to a plate level control (i.e., a blank well run on each plate). Net MFI less than 1 is set to 1, and net MFI \> 22,000 is set to 22,000. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500. Samples from post-enrollment visits have positive responses if: (1) the net MFI (MFI minus Blank) values were ≥ antigen-specific cutoff at the 1:50 dilution level for IgG, (2) the net MFI values were greater than 3 times the baseline (day 0) net MFI, and (3) the MFI values were greater than 3 times the baseline MFI values.
Outcome measures
| Measure |
Group 1: Vaccine
n=12 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=13 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Levels of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins (Measured by Net MFI)
CH505TF gp120 Stable
|
22000 Net mean fluorescent intensity (net MFI)
Interval 22000.0 to 22000.0
|
22000 Net mean fluorescent intensity (net MFI)
Interval 22000.0 to 22000.0
|
|
Levels of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins (Measured by Net MFI)
CH505TF gp120 Transient
|
22000 Net mean fluorescent intensity (net MFI)
Interval 22000.0 to 22000.0
|
22000 Net mean fluorescent intensity (net MFI)
Interval 22000.0 to 22000.0
|
PRIMARY outcome
Timeframe: Measured at Month 6.5Population: "Overall number of participants analyzed" represents the number of participants with positive total IgG Binding Antibody responses at Month 6.5. "Number Analyzed" shows the number of participants with positive total IgG Binding Antibody responses after filtering for assay specific quality control criteria at Month 6.5.
Samples were titrated for IgG to CH505TF gp120 (transient transfection) and CH505TF gp120 (stable transfection) at month 0 (Visit 2) and month 6.5 (Visit 7), with a starting 1:50 dilution followed by a 5-fold dilution series, ending at 1:156250 dilution. The AUC value was calculated using the trapezoidal rule based on the raw MFI values truncated at zero across the log base 10 dilution series. For each combination of individual and antigen, AUC at each time point was the sum of the areas of the trapezoids calculated between any non-excluded data points in the analyte/titration. AUC was not calculated for any samples which were incompletely titrated, or where a dilution was missing due to failing QC criteria. Data are excluded if blood draw date was outside the allowable window, a participant was HIV-infected, reference antigen \> 5,000 MFI, or baseline net MFI \> 6,500.
Outcome measures
| Measure |
Group 1: Vaccine
n=12 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=13 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins
CH505TF gp120 Stable
|
21550.9 MFI*log10(1/dilution)
Interval 16359.2 to 29267.1
|
34973.9 MFI*log10(1/dilution)
Interval 19147.8 to 39506.9
|
|
Area Under Titration Curve of HIV-specific Total IgG Binding Antibody Response Elicited by the CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods Against the Homologous Proteins
CH505TF gp120 Transient
|
23190.6 MFI*log10(1/dilution)
Interval 18054.6 to 30777.6
|
36942.1 MFI*log10(1/dilution)
Interval 21130.4 to 43019.9
|
SECONDARY outcome
Timeframe: Measured at Months 2.5 and 6.5Population: "Overall number of participants analyzed" represents the HIV uninfected participants with available nAB data at Months 2.5 and/or 6.5. "Number Analyzed" shows the number of HIV uninfected participants with available nAB data after filtering for assay specific quality control criteria at each timepoint.
Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tatregulated luciferase (Luc) reporter gene expression in TZMbl cells. Response to a virus/isolate was considered positive if the neutralization titer was above a prespecified cutoff. A titer was defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). The prespecified cutoff for ID50 and ID80 was 10. Data are excluded if blood draw date was outside the allowable window, assay results are deemed unreliable for analysis by the lab, or a participant was HIV-infected.
Outcome measures
| Measure |
Group 1: Vaccine
n=14 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=14 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505.w4.3, Titer, (ID50), V5, M2.5
|
11 Participants
|
13 Participants
|
|
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505.w4.3, Titer (ID50), V7, M6.5
|
12 Participants
|
14 Participants
|
|
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505.w4.3, Titer (ID80), V5, M2.5
|
10 Participants
|
12 Participants
|
|
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505.w4.3, Titer (ID80), V7, M6.5
|
11 Participants
|
13 Participants
|
|
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505TF, Titer (ID50), V5, M2.5
|
0 Participants
|
0 Participants
|
|
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505TF, Titer (ID50), V7, M6.5
|
0 Participants
|
2 Participants
|
|
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505TF, Titer (ID80), V5, M2.5
|
0 Participants
|
0 Participants
|
|
Occurrence of Neutralizing Antibody (nAB) Response Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505TF, Titer (ID80), V7, M6.5
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Measured at Months 2.5 and 6.5Population: "Overall number of participants analyzed" represents the number of participants with positive nAB responses at Months 2.5 and/or 6.5. "Number Analyzed" shows the number of participants with positive nAB responses after filtering for assay specific quality control criteria at each timepoint.
Neutralizing antibodies against tier 1 and tier 2 strains of HIV-1 were measured as a function of reductions in Tatregulated luciferase (Luc) reporter gene expression in TZMbl cells. Response magnitudes were assessed using neutralization titer, which is defined as the serum dilution that reduced relative luminescence units (RLUs) by 50% and 80% relative to the RLUs in virus control wells (cells + virus only) after subtraction of background RLU (cells only). Higher neutralization titer indicates higher response level. Response to a virus/isolate was considered positive if the neutralization titer was above 10. Data are excluded if blood draw date was outside the allowable window, assay results are deemed unreliable for analysis by the lab, or a participant was HIV-infected.
Outcome measures
| Measure |
Group 1: Vaccine
n=13 Participants
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2, and 6
|
Group 2: Vaccine
n=14 Participants
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505.w4.3, Titer (ID50), V5, M2.5
|
135.7 1/dilution
Interval 72.8 to 226.7
|
122.9 1/dilution
Interval 68.8 to 185.1
|
|
Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505.w4.3, Titer (ID50), V5, M6.5
|
492.5 1/dilution
Interval 144.7 to 1126.3
|
404.1 1/dilution
Interval 219.9 to 1274.9
|
|
Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505.w4.3, Titer (ID80), V7, M2.5
|
32.9 1/dilution
Interval 24.6 to 56.5
|
39.4 1/dilution
Interval 25.5 to 55.8
|
|
Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505.w4.3, Titer (ID80), V7, M6.5
|
173.2 1/dilution
Interval 77.4 to 300.8
|
135.7 1/dilution
Interval 77.0 to 356.7
|
|
Neutralization Titers of nAB Responses Against CH505TF gp120 Proteins Produced Via Transient and Stable Transfection Methods
CH505TF, Titer (ID50), V5, M6.5
|
—
|
11.6 1/dilution
Interval 11.5 to 11.7
|
Adverse Events
Group 1: Vaccine
Serious events: 1 serious events
Other events: 7 other events
Deaths: 0 deaths
Group 2: Vaccine
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Group 1: Vaccine
n=15 participants at risk
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
Group 2: Vaccine
n=15 participants at risk
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Nervous system disorders
Any Event in SOC
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Nervous system disorders
Migraine
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
Other adverse events
| Measure |
Group 1: Vaccine
n=15 participants at risk
100 mcg of Stable CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
Group 2: Vaccine
n=15 participants at risk
100 mcg of Transient CH505TF gp120 admixed with 10 mcg of GLA-SE, to be administered as a 1mL IM injection in the deltoid of the non-dominant arm at months 0, 2 and 6
|
|---|---|---|
|
Blood and lymphatic system disorders
Any Event in SOC
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
General disorders
Any Event in SOC
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
General disorders
Influenza like illness
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Infections and infestations
Any Event in SOC
|
20.0%
3/15 • Number of events 3 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
33.3%
5/15 • Number of events 5 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Infections and infestations
Influenza
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
13.3%
2/15 • Number of events 2 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Infections and infestations
Upper respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Injury, poisoning and procedural complications
Any Event in SOC
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Investigations
Any Event in SOC
|
20.0%
3/15 • Number of events 6 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
20.0%
3/15 • Number of events 3 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Investigations
Alanine aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Investigations
Aspartate aminotransferase increased
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Investigations
Blood creatine increased
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Investigations
Blood creatine phosphokinase increased
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Investigations
Blood pressure increased
|
20.0%
3/15 • Number of events 3 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Investigations
Haemoglobin decreased
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Musculoskeletal and connective tissue disorders
Any Event in SOC
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Nervous system disorders
Any Event in SOC
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Nervous system disorders
Sensory disturbance
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Respiratory, thoracic and mediastinal disorders
Any Event in SOC
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Vascular disorders
Any Event in SOC
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
|
Vascular disorders
Haematoma
|
6.7%
1/15 • Number of events 1 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
0.00%
0/15 • Serious Adverse events and non-serious adverse are collected until month 12. All-cause mortality are collected until month 18.
|
Additional Information
Jessica Andriesen, PhD, Associate Director of HVTN SDMC Operations
Fred Hutchinson Cancer Research Center
Phone: 206-667-5812
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place