Trial Outcomes & Findings for Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART (NCT NCT00270205)
NCT ID: NCT00270205
Last Updated: 2021-11-04
Results Overview
Primary safety endpoint is defined as occurrence of at least one grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment. Event's relationship to the study treatment was determined by the protocol core team, including site clinicians on the team, blinded to the treatment arm. Adverse events solely attributed to an allergic reaction to the adhesive of the tape used to adhere the vaccination patch to the skin and not the vaccine itself were not used in determination of the primary safety endpoint.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
28 participants
Primary outcome timeframe
From start of study vaccination to 28 days after the last study vaccination
Results posted on
2021-11-04
Participant Flow
Participants were enrolled from February 2006 to October 2008 in 5 different U.S. sites. Enrollment was done by cohort with each cohort enrolling six participants for LC002 vaccine and 2 participants for its corresponding placebo. Cohorts were enrolled sequentially, with later cohorts receiving higher dose of the LC002 vaccine.
Study participants were HIV-1-infected men and women 18-50 years of age with CD4 count \>350 cells/mm\^3 and plasma HIV-1 RNA \<50 copies/ml (on an ultrasensitive assay) and who were on a stable HAART regimen. One enrolled participant never started study treatment/vaccination.
Participant milestones
| Measure |
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
|---|---|---|---|---|
|
Overall Study
STARTED
|
6
|
6
|
6
|
7
|
|
Overall Study
COMPLETED
|
5
|
6
|
6
|
6
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
0
|
1
|
Reasons for withdrawal
| Measure |
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
|---|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
0
|
1
|
Baseline Characteristics
Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART
Baseline characteristics by cohort
| Measure |
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=6 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=7 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
Total
n=25 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
44 years
n=5 Participants
|
41 years
n=7 Participants
|
46 years
n=5 Participants
|
34 years
n=4 Participants
|
39 years
n=21 Participants
|
|
Age, Customized
18-30
|
1 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
2 participants
n=4 Participants
|
5 participants
n=21 Participants
|
|
Age, Customized
31-40
|
2 participants
n=5 Participants
|
2 participants
n=7 Participants
|
1 participants
n=5 Participants
|
5 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Age, Customized
41-50
|
3 participants
n=5 Participants
|
3 participants
n=7 Participants
|
4 participants
n=5 Participants
|
0 participants
n=4 Participants
|
10 participants
n=21 Participants
|
|
Sex: Female, Male
Female
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
6 Participants
n=4 Participants
|
23 Participants
n=21 Participants
|
|
Region of Enrollment
United States
|
6 participants
n=5 Participants
|
6 participants
n=7 Participants
|
6 participants
n=5 Participants
|
7 participants
n=4 Participants
|
25 participants
n=21 Participants
|
PRIMARY outcome
Timeframe: From start of study vaccination to 28 days after the last study vaccinationPopulation: Only those participants who started study treatment/vaccination were included in the analysis.
Primary safety endpoint is defined as occurrence of at least one grade 3 or higher adverse event, including signs/symptoms, lab toxicities, and/or clinical events that is possibly or definitely related to study treatment. Event's relationship to the study treatment was determined by the protocol core team, including site clinicians on the team, blinded to the treatment arm. Adverse events solely attributed to an allergic reaction to the adhesive of the tape used to adhere the vaccination patch to the skin and not the vaccine itself were not used in determination of the primary safety endpoint.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=6 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=7 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Percent of Participants With Primary Safety Endpoint
|
0 percentage of participants
Interval 0.0 to 40.2
|
0 percentage of participants
Interval 0.0 to 37.7
|
0 percentage of participants
Interval 0.0 to 40.2
|
0 percentage of participants
Interval 0.0 to 40.2
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 61Population: Only those participants who started study vaccination and who have complete and non-missing CD4+ T-cell count responses at all study visits were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method, of CD4+ T-cell count responses was used to characterize each participant's overall CD4+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=5 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=4 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs
|
745.0 cells/mm3
Interval 484.0 to 765.0
|
731.0 cells/mm3
Interval 552.0 to 769.0
|
735.0 cells/mm3
Interval 658.0 to 765.0
|
1169.5 cells/mm3
Interval 752.0 to 1424.5
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 61Population: Only those participants who started study vaccination and who have complete and non-missing CD8+ T-cell count responses at all study visits were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method, of CD8+ T-cell count responses was used to characterize each participant's overall CD8+ count response. Each AUC was divided by 61 weeks to have the same unit as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=5 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=4 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of CD8+ T-cell Count in PBMCs
|
686.0 cells/mm^3
Interval 590.0 to 697.0
|
587.0 cells/mm^3
Interval 483.0 to 842.0
|
612.0 cells/mm^3
Interval 601.0 to 682.0
|
1061.0 cells/mm^3
Interval 539.0 to 1402.0
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 37Population: Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.
At each week, the mean spot-forming cells/10\^6 PBMCs detected by the PHPC (precursors with high proliferative capacity) assay across gag p17, gag p24, gag p15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=6 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
|
920.1 spot-forming cells/10^6 PBMC
Interval 133.6 to 4817.9
|
1760.4 spot-forming cells/10^6 PBMC
Interval 650.0 to 3122.9
|
16441.8 spot-forming cells/10^6 PBMC
Interval 1896.1 to 37519.0
|
25797.0 spot-forming cells/10^6 PBMC
Interval 4708.3 to 46438.4
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 37Population: Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen as detected by the PHPC assay. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=6 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
gag p17
|
1422.0 spot-forming cells/10^6 PBMC
Interval 104.5 to 7798.8
|
3120.7 spot-forming cells/10^6 PBMC
Interval 1076.0 to 6756.2
|
18779.2 spot-forming cells/10^6 PBMC
Interval 2232.8 to 25283.1
|
6653.5 spot-forming cells/10^6 PBMC
Interval 4282.8 to 7466.4
|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
gag p24
|
585.1 spot-forming cells/10^6 PBMC
Interval 244.8 to 1360.1
|
641.2 spot-forming cells/10^6 PBMC
Interval 292.7 to 1749.9
|
15691.4 spot-forming cells/10^6 PBMC
Interval 2351.1 to 89228.3
|
33446.0 spot-forming cells/10^6 PBMC
Interval 6903.0 to 77524.8
|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
gag p15
|
1163.5 spot-forming cells/10^6 PBMC
Interval 163.9 to 2340.1
|
2244.4 spot-forming cells/10^6 PBMC
Interval 91.5 to 3349.3
|
17977.7 spot-forming cells/10^6 PBMC
Interval 723.8 to 23520.9
|
13921.4 spot-forming cells/10^6 PBMC
Interval 6206.1 to 60107.5
|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each PHPC Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
tat/rev
|
268.3 spot-forming cells/10^6 PBMC
Interval 38.8 to 1149.9
|
712.8 spot-forming cells/10^6 PBMC
Interval 18.8 to 2035.2
|
1272.0 spot-forming cells/10^6 PBMC
Interval 630.2 to 5226.8
|
2912.0 spot-forming cells/10^6 PBMC
Interval 2168.3 to 9518.1
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 37Population: Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.
At each week, the mean spot-forming cells/10\^6 PBMCs across gag p17, gag p24, gag 15 and tat/rev was obtained per participant. Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=6 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by Taking the Mean of the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
|
214.2 spot-forming cells/10^6 PBMC
Interval 59.4 to 576.2
|
126.7 spot-forming cells/10^6 PBMC
Interval 68.7 to 145.3
|
421.8 spot-forming cells/10^6 PBMC
Interval 401.8 to 443.0
|
274.5 spot-forming cells/10^6 PBMC
Interval 134.0 to 784.1
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 37Population: Only those participants who started study vaccination and who have complete and non-missing mean responses to gag-1, gag-2, gag-3 and tat/rev through 37 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method for each antigen was used to characterize each participant's overall response to the antigen. Each AUC was divided by 37 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=6 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
gag p17
|
409.8 spot-forming cells/10^6 PBMC
Interval 159.8 to 1028.9
|
152.6 spot-forming cells/10^6 PBMC
Interval 57.8 to 234.1
|
270.9 spot-forming cells/10^6 PBMC
Interval 130.0 to 364.7
|
186.5 spot-forming cells/10^6 PBMC
Interval 25.8 to 332.5
|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
gag p24
|
135.3 spot-forming cells/10^6 PBMC
Interval 54.3 to 1193.5
|
103.8 spot-forming cells/10^6 PBMC
Interval 29.1 to 256.9
|
213.6 spot-forming cells/10^6 PBMC
Interval 113.0 to 795.9
|
458.4 spot-forming cells/10^6 PBMC
Interval 345.6 to 1999.4
|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
gag p15
|
31.0 spot-forming cells/10^6 PBMC
Interval 14.4 to 184.6
|
95.4 spot-forming cells/10^6 PBMC
Interval 35.0 to 277.5
|
141.5 spot-forming cells/10^6 PBMC
Interval 85.4 to 379.5
|
345.8 spot-forming cells/10^6 PBMC
Interval 31.5 to 386.1
|
|
Time-averaged AUC of the Magnitude of HIV-specific Immune Response, as Determined by the Number of Spot-forming Cells/10^6 PBMCs Observed in Each ELISPOT Assay for IFN-gamma Production for Gag p17, Gag p24, Gag p15 and Tat/Rev.
tat/rev
|
31.7 spot-forming cells/10^6 PBMC
Interval 15.3 to 133.5
|
33.3 spot-forming cells/10^6 PBMC
Interval 7.0 to 55.3
|
7.9 spot-forming cells/10^6 PBMC
Interval 6.0 to 419.6
|
22.9 spot-forming cells/10^6 PBMC
Interval 5.9 to 174.6
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 61Population: All participants who started study vaccination and who have anti-ds DNA results at baseline and week 17 or 61 were included in the analysis.
Results report the number of participants who had negative anti-dsDNA antibody result at baseline and at week 17 or 61.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=6 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Anti-dsDNA Antibody Response
|
6 participants
|
6 participants
|
5 participants
|
6 participants
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev
p24
|
27.1 cells/mm3
Interval 13.2 to 32.3
|
13.0 cells/mm3
Interval 5.1 to 19.3
|
46.4 cells/mm3
Interval 44.8 to 91.7
|
21.5 cells/mm3
Interval 11.4 to 26.7
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev
gag/pol/env
|
8.4 cells/mm3
Interval 7.8 to 22.2
|
16.8 cells/mm3
Interval 0.5 to 25.7
|
27.5 cells/mm3
Interval 12.5 to 36.7
|
9.2 cells/mm3
Interval 8.0 to 20.5
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev
tat/rev
|
0.2 cells/mm3
Interval 0.0 to 0.3
|
10.1 cells/mm3
Interval 1.8 to 14.7
|
4.0 cells/mm3
Interval 1.1 to 14.2
|
4.0 cells/mm3
Interval 1.2 to 8.6
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to whole HIV-1 antigen were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=3 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen
|
4.6 cells/mm^3
Interval 0.0 to 28.9
|
6.0 cells/mm^3
Interval 3.5 to 73.0
|
305.3 cells/mm^3
Interval 19.5 to 328.3
|
68.6 cells/mm^3
Interval 6.2 to 459.0
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks to anti-CD3 antigen were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=5 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3
|
200.4 cells/mm^3
Interval 182.0 to 274.2
|
248.8 cells/mm^3
Interval 213.4 to 293.3
|
333.6 cells/mm^3
Interval 298.5 to 355.4
|
334.9 cells/mm^3
Interval 210.4 to 548.6
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev.
p24
|
4.9 percent
Interval 1.4 to 6.9
|
2.0 percent
Interval 0.7 to 3.1
|
10.0 percent
Interval 6.7 to 11.3
|
3.5 percent
Interval 1.2 to 4.6
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev.
gag/pol/env
|
1.8 percent
Interval 0.9 to 2.2
|
2.5 percent
Interval 0.1 to 3.7
|
4.3 percent
Interval 1.7 to 4.7
|
1.4 percent
Interval 1.1 to 2.2
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env and Tat/Rev.
tat/rev
|
0 percent
Interval 0.0 to 0.1
|
1.4 percent
Interval 0.2 to 1.8
|
0.6 percent
Interval 0.2 to 1.7
|
0.3 percent
Interval 0.1 to 1.9
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=3 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Whole HIV-1 Antigen
|
1.1 percent
Interval 0.0 to 7.1
|
0.9 percent
Interval 0.5 to 15.2
|
42.0 percent
Interval 3.0 to 64.8
|
10.6 percent
Interval 1.7 to 44.2
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=5 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3
|
31.1 percent
Interval 31.1 to 38.3
|
48.5 percent
Interval 36.2 to 49.1
|
47.7 percent
Interval 41.3 to 51.8
|
37.4 percent
Interval 35.7 to 53.7
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.
p24
|
1.0 cells/mm^3
Interval 0.8 to 5.0
|
2.5 cells/mm^3
Interval 0.8 to 5.1
|
10.5 cells/mm^3
Interval 5.3 to 14.7
|
11.1 cells/mm^3
Interval 3.5 to 12.0
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.
gag/pol/env
|
38.2 cells/mm^3
Interval 22.4 to 62.2
|
44.3 cells/mm^3
Interval 31.6 to 49.4
|
88.7 cells/mm^3
Interval 72.8 to 107.0
|
59.1 cells/mm^3
Interval 34.4 to 68.4
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.
tat/rev
|
5.7 cells/mm^3
Interval 0.2 to 17.4
|
3.8 cells/mm^3
Interval 1.6 to 6.1
|
2.5 cells/mm^3
Interval 2.2 to 45.5
|
4.8 cells/mm^3
Interval 1.7 to 17.1
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.
HIV-1 MN
|
73.5 cells/mm^3
Interval 53.3 to 111.9
|
89.7 cells/mm^3
Interval 37.1 to 118.5
|
118.6 cells/mm^3
Interval 43.9 to 169.0
|
120.3 cells/mm^3
Interval 60.9 to 130.9
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=5 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3
|
350.4 cells/mm^3
Interval 332.3 to 375.6
|
278.9 cells/mm^3
Interval 222.2 to 449.4
|
330.6 cells/mm^3
Interval 313.7 to 331.1
|
486.2 cells/mm^3
Interval 458.6 to 727.9
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.
p24
|
0.1 percent
Interval 0.1 to 0.6
|
0.5 percent
Interval 0.1 to 0.7
|
2.1 percent
Interval 1.0 to 2.6
|
0.7 percent
Interval 0.4 to 1.4
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.
gag/pol/env
|
6.0 percent
Interval 3.0 to 7.4
|
6.0 percent
Interval 5.2 to 11.7
|
14.3 percent
Interval 9.9 to 15.1
|
4.8 percent
Interval 1.5 to 7.4
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.
tat/rev
|
1.1 percent
Interval 0.0 to 2.6
|
0.5 percent
Interval 0.3 to 0.7
|
0.5 percent
Interval 0.3 to 4.0
|
0.4 percent
Interval 0.2 to 1.0
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to p24 Protein, Gag/Pol/Env, Tat/Rev and Whole HIV-1 Antigen.
HIV-1 MN
|
10.4 percent
Interval 7.0 to 16.5
|
15.4 percent
Interval 6.5 to 16.7
|
24.9 percent
Interval 7.5 to 26.0
|
7.5 percent
Interval 6.1 to 12.0
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=5 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=5 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry With CFSE Staining to Detect Antigen-specific Lymphocyte Proliferation Responding to Anti-CD3
|
48.5 percent
Interval 43.2 to 63.9
|
53.5 percent
Interval 47.9 to 62.5
|
58.4 percent
Interval 57.5 to 62.7
|
54.3 percent
Interval 34.5 to 67.7
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=4 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
gag/pol/env
|
0.1 cells/mm^3
Interval 0.0 to 0.3
|
0 cells/mm^3
Interval 0.0 to 0.2
|
0.7 cells/mm^3
Interval 0.7 to 1.0
|
0 cells/mm^3
Interval 0.0 to 0.1
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
HIV-1 MN
|
0.1 cells/mm^3
Interval 0.0 to 0.3
|
0 cells/mm^3
Interval 0.0 to 0.0
|
1.2 cells/mm^3
Interval 0.7 to 1.4
|
0.3 cells/mm^3
Interval 0.0 to 0.5
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
tat/rev
|
0 cells/mm^3
Interval 0.0 to 0.0
|
0.2 cells/mm^3
Interval 0.0 to 0.6
|
0.4 cells/mm^3
Interval 0.3 to 0.8
|
0.3 cells/mm^3
Interval 0.2 to 0.3
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
SEB
|
6.1 cells/mm^3
Interval 4.7 to 23.5
|
10.4 cells/mm^3
Interval 7.4 to 18.4
|
18.3 cells/mm^3
Interval 17.4 to 21.7
|
24.2 cells/mm^3
Interval 7.6 to 65.4
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=4 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
SEB
|
1.2 percent
Interval 1.0 to 3.7
|
2.0 percent
Interval 1.4 to 2.4
|
2.6 percent
Interval 2.2 to 2.9
|
3.6 percent
Interval 1.1 to 8.2
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
HIV-1 MN
|
0 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.0
|
0.2 percent
Interval 0.1 to 0.2
|
0 percent
Interval 0.0 to 0.1
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
gag/pol/env
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.1
|
0.1 percent
Interval 0.1 to 0.2
|
0 percent
Interval 0.0 to 0.0
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
tat/rev
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.1
|
0.1 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=4 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
HIV-1 MN
|
0 cells/mm^3
Interval 0.0 to 0.5
|
0 cells/mm^3
Interval 0.0 to 0.1
|
0.4 cells/mm^3
Interval 0.0 to 0.4
|
0.3 cells/mm^3
Interval 0.2 to 0.5
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
gag/pol/env
|
1.0 cells/mm^3
Interval 0.2 to 1.8
|
1.0 cells/mm^3
Interval 0.1 to 2.0
|
3.1 cells/mm^3
Interval 1.0 to 3.2
|
2.0 cells/mm^3
Interval 1.9 to 10.5
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
tat/rev
|
0.3 cells/mm^3
Interval 0.1 to 0.7
|
1.1 cells/mm^3
Interval 0.6 to 1.9
|
2.2 cells/mm^3
Interval 0.4 to 5.6
|
0.5 cells/mm^3
Interval 0.5 to 1.2
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
SEB
|
32.2 cells/mm^3
Interval 16.2 to 49.1
|
17.2 cells/mm^3
Interval 9.4 to 30.6
|
19.2 cells/mm^3
Interval 11.0 to 25.5
|
31.4 cells/mm^3
Interval 25.0 to 35.9
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=4 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
HIV-1 MN
|
0 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.1
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
gag/pol/env
|
0.2 percent
Interval 0.1 to 0.3
|
0.1 percent
Interval 0.0 to 0.3
|
0.5 percent
Interval 0.1 to 0.7
|
0.2 percent
Interval 0.2 to 0.6
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
tat/rev
|
0.1 percent
Interval 0.0 to 0.1
|
0.2 percent
Interval 0.1 to 0.3
|
0.3 percent
Interval 0.1 to 0.9
|
0.1 percent
Interval 0.0 to 0.3
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IFN-gamma-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
SEB
|
5.1 percent
Interval 3.7 to 6.8
|
3.1 percent
Interval 2.8 to 3.3
|
4.0 percent
Interval 3.0 to 4.1
|
4.9 percent
Interval 1.7 to 6.0
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=4 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
SEB
|
7.9 cells/mm^3
Interval 5.0 to 11.5
|
12.7 cells/mm^3
Interval 8.2 to 15.8
|
16.9 cells/mm^3
Interval 10.6 to 17.6
|
13.6 cells/mm^3
Interval 7.0 to 19.5
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
HIV-1 MN
|
0 cells/mm^3
Interval 0.0 to 0.7
|
0 cells/mm^3
Interval 0.0 to 0.1
|
0.6 cells/mm^3
Interval 0.0 to 0.6
|
0.1 cells/mm^3
Interval 0.1 to 0.2
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
gag/pol/env
|
0 cells/mm^3
Interval 0.0 to 0.1
|
0.1 cells/mm^3
Interval 0.0 to 0.3
|
0.1 cells/mm^3
Interval 0.1 to 0.3
|
0 cells/mm^3
Interval 0.0 to 0.2
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
tat/rev
|
0 cells/mm^3
Interval 0.0 to 0.0
|
0.1 cells/mm^3
Interval 0.0 to 0.4
|
0.2 cells/mm^3
Interval 0.0 to 0.4
|
0 cells/mm^3
Interval 0.0 to 0.1
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=4 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
HIV-1 MN
|
0 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.0
|
0.1 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.0
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
gag/pol/env
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.0
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
tat/rev
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.0
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD4+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
SEB
|
1.5 percent
Interval 1.1 to 1.8
|
2.1 percent
Interval 1.6 to 2.9
|
2.1 percent
Interval 1.9 to 2.2
|
1.9 percent
Interval 1.8 to 2.4
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=4 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
HIV-1 MN
|
0 cells/mm^3
Interval 0.0 to 1.3
|
0.1 cells/mm^3
Interval 0.0 to 0.1
|
0 cells/mm^3
Interval 0.0 to 0.3
|
0.1 cells/mm^3
Interval 0.1 to 0.3
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
gag/pol/env
|
0 cells/mm^3
Interval 0.0 to 0.3
|
0 cells/mm^3
Interval 0.0 to 0.1
|
0.3 cells/mm^3
Interval 0.0 to 0.3
|
0.3 cells/mm^3
Interval 0.0 to 0.5
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
tat/rev
|
0 cells/mm^3
Interval 0.0 to 0.1
|
0 cells/mm^3
Interval 0.0 to 0.1
|
0.3 cells/mm^3
Interval 0.1 to 0.5
|
0 cells/mm^3
Interval 0.0 to 0.2
|
|
Time-averaged AUC of T-cell Count of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
SEB
|
4.2 cells/mm^3
Interval 2.9 to 5.7
|
2.1 cells/mm^3
Interval 1.1 to 3.5
|
1.9 cells/mm^3
Interval 1.4 to 2.8
|
5.3 cells/mm^3
Interval 3.4 to 9.2
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Area under the curve (AUC) using linear trapezoidal method was used to characterize each participant's overall response. Each AUC was divided by 24 weeks to have the same unit of measure as the raw data.
Outcome measures
| Measure |
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=4 Participants
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=6 Participants
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=5 Participants
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 Participants
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
|---|---|---|---|---|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
HIV-1 MN
|
0 percent
Interval 0.0 to 0.2
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
gag/pol/env
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
0.1 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.1
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
tat/rev
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.0
|
0 percent
Interval 0.0 to 0.1
|
0 percent
Interval 0.0 to 0.1
|
|
Time-averaged AUC of T-cell Percent of HIV-1-specific CD8+ T-cell Subsets, Based on Flow Cytometry to Detect Antigen-specific IL-2-producing Cells Responding to Whole Zn-finger Inactivated Virus Stimulation and Various HIV-1 Peptide Antigens
SEB
|
0.7 percent
Interval 0.4 to 1.4
|
0.3 percent
Interval 0.2 to 0.5
|
0.3 percent
Interval 0.3 to 0.4
|
0.5 percent
Interval 0.3 to 1.5
|
SECONDARY outcome
Timeframe: From start of study vaccination to week 24Population: There are no data available for the analysis.
The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.
Outcome measures
Outcome data not reported
OTHER_PRE_SPECIFIED outcome
Timeframe: From start of study vaccination to week 24Population: There are no data available for the analysis.
Additional outcome measure for possible supportive exploratory analysis. The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.
Outcome measures
Outcome data not reported
Adverse Events
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Placebo
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 participants at risk
Participants receiving three separate low-dose vaccinations of LC002 (0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites \[on the left and right upper back\] of 80 cm\^2 each, 0.4 ml/site) at weeks 1, 7, and 13.
|
C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13
n=6 participants at risk
Participants receiving three separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at weeks 1, 7, and 13.
|
E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13
n=6 participants at risk
Participants receiving six separate high-dose vaccinations of LC002 (0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites \[on the left and right upper back and left and right upper ventral thigh\] of 80 cm\^2 each, 0.8 ml/site) at study entry and weeks 1, 6, 7, 12, and 13.
|
Placebo
n=7 participants at risk
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
|
|---|---|---|---|---|
|
Blood and lymphatic system disorders
Lymphadenopathy
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Eye disorders
Eye pain
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Eye disorders
Lacrimation decreased
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Eye disorders
Macular degeneration
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Abdominal distension
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Abdominal pain lower
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Hiatus hernia
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Nausea
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Proctalgia
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Rectal ulcer
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Gastrointestinal disorders
Vomiting
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
General disorders
Chills
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
General disorders
Fatigue
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
28.6%
2/7 • From start of study vaccination to week 61
|
|
General disorders
Injection site discomfort
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
General disorders
Injection site erythema
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
42.9%
3/7 • From start of study vaccination to week 61
|
|
General disorders
Injection site mass
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
General disorders
Injection site pain
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
General disorders
Injection site pruritus
|
50.0%
3/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
General disorders
Malaise
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
General disorders
Oedema peripheral
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
General disorders
Pain
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
General disorders
Pyrexia
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
General disorders
Vaccination site erythema
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
General disorders
Vaccination site pain
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
General disorders
Vaccination site reaction
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Infections and infestations
Hordeolum
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Infections and infestations
Secondary syphilis
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Injury, poisoning and procedural complications
Burns second degree
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Investigations
Aspartate aminotransferase increased
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Investigations
Blood bicarbonate
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Investigations
Blood creatine phosphokinase increased
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Investigations
Blood creatinine increased
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Investigations
Blood glucose abnormal
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Investigations
Blood glucose decreased
|
0.00%
0/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Investigations
Blood phosphorus decreased
|
33.3%
2/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Investigations
Blood sodium decreased
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Investigations
Weight decreased
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Metabolism and nutrition disorders
Decreased appetite
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
50.0%
3/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Musculoskeletal and connective tissue disorders
Groin pain
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Nervous system disorders
Amnesia
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Nervous system disorders
Dizziness
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
28.6%
2/7 • From start of study vaccination to week 61
|
|
Nervous system disorders
Dysgeusia
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Nervous system disorders
Headache
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Psychiatric disorders
Insomnia
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.00%
0/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory tract congestion
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Skin and subcutaneous tissue disorders
Alopecia areata
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Skin and subcutaneous tissue disorders
Erythema
|
33.3%
2/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
66.7%
4/6 • From start of study vaccination to week 61
|
42.9%
3/7 • From start of study vaccination to week 61
|
|
Skin and subcutaneous tissue disorders
Lipoatrophy
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Skin and subcutaneous tissue disorders
Papule
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
100.0%
6/6 • From start of study vaccination to week 61
|
42.9%
3/7 • From start of study vaccination to week 61
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
0.00%
0/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Skin and subcutaneous tissue disorders
Rash macular
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
14.3%
1/7 • From start of study vaccination to week 61
|
|
Skin and subcutaneous tissue disorders
Rash papular
|
0.00%
0/6 • From start of study vaccination to week 61
|
16.7%
1/6 • From start of study vaccination to week 61
|
33.3%
2/6 • From start of study vaccination to week 61
|
0.00%
0/7 • From start of study vaccination to week 61
|
Additional Information
ACTG Clinicaltrials.gov Coordinator
ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee In accordance with the Clinical Trial Agreement between NIAID (DAIDS) and company collaborators, NIAID (DAIDS) provides companies with a copy of any abstract, press release, or manuscript prior to submission for publication with sufficient time for company review and comment. The publication/other disclosure can be delayed for up to 30 additional business days for manuscripts and five (5) business days for abstracts, to preserve U.S. or foreign patent or other intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER