Safety, Tolerability and Immune Response to LC002, an Experimental Therapeutic Vaccine, in Adults Receiving HAART

This study has been completed.

Sponsor:

Collaborator:

AIDS Clinical Trials Group

Information provided by (Responsible Party):

National Institute of Allergy and Infectious Diseases (NIAID)

ClinicalTrials.gov Identifier:

NCT00270205

First received: December 21, 2005

Last updated: May 17, 2012

Last verified: May 2012

History of Changes

Results First Received: September 7, 2011

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety/Efficacy Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Caregiver, Investigator); Primary Purpose: Treatment
Condition:	HIV Infections
Interventions:	Biological: LC002 standard vaccination Biological: LC002 high-dose vaccination Biological: LC002 placebo vaccination

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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.

Reporting Groups

	Description
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.

Participant Flow: Overall Study

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
STARTED	6	6 ^[1]	6	7
COMPLETED	5	6	6	6
NOT COMPLETED	1	0	0	1
Lost to Follow-up	1	0	0	1

[1]	7 participants enrolled. One never started study vaccination and was excluded from all analyses.

Baseline Characteristics

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Reporting Groups

	Description
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.
Total	Total of all reporting groups

Baseline Measures

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo	Total
Number of Participants [units: participants]	6	6	6	7	25
Age ^[1] [units: years] Median ( Inter-Quartile Range )	44 ( 32 to 48 )	41 ( 38 to 43 )	46 ( 34 to 47 )	34 ( 30 to 35 )	39 ( 32 to 45 )
Age, Customized ^[1] [units: participants]
18-30	1	1	1	2	5
31-40	2	2	1	5	10
41-50	3	3	4	0	10
Gender ^[2] [units: participants]
Female	1	0	0	1	2
Male	5	6	6	6	23
Region of Enrollment [units: participants]
United States	6	6	6	7	25

[1]	Age (in years) at study entry. Participants who never started study vaccination were excluded.
[2]	Participants who never started study vaccination were excluded.

Outcome Measures

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1. Primary:

Percent of Participants With Primary Safety Endpoint [ Time Frame: From start of study vaccination to 28 days after the last study vaccination ]

Measure Type	Primary
Measure Title	Percent of Participants With Primary Safety Endpoint
Measure Description	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.
Time Frame	From start of study vaccination to 28 days after the last study vaccination
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study treatment/vaccination were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	6	6	6	7
Percent of Participants With Primary Safety Endpoint [units: percentage of participants] Number ( 95% Confidence Interval )	0 ( 0 to 40.2 )	0 ( 0 to 40.2 )	0 ( 0 to 40.2 )	0 ( 0 to 37.7 )

No statistical analysis provided for Percent of Participants With Primary Safety Endpoint

2. Secondary:

Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs [ Time Frame: From start of study vaccination to week 61 ]

Measure Type	Secondary
Measure Title	Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs
Measure Description	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.
Time Frame	From start of study vaccination to week 61
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	4	5	5
Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs [units: cells/mm3] Median ( Inter-Quartile Range )	735.0 ( 658.0 to 765.0 )	1169.5 ( 752.0 to 1424.5 )	745.0 ( 484.0 to 765.0 )	731.0 ( 552.0 to 769.0 )

No statistical analysis provided for Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs

3. Secondary:

Time-averaged AUC of CD8+ T-cell Count in PBMCs [ Time Frame: From start of study vaccination to week 61 ]

Measure Type	Secondary
Measure Title	Time-averaged AUC of CD8+ T-cell Count in PBMCs
Measure Description	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.
Time Frame	From start of study vaccination to week 61
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	4	5	5
Time-averaged AUC of CD8+ T-cell Count in PBMCs [units: cells/mm^3] Median ( Inter-Quartile Range )	612.0 ( 601.0 to 682.0 )	1061.0 ( 539.0 to 1402.0 )	686.0 ( 590.0 to 697.0 )	587.0 ( 483.0 to 842.0 )

No statistical analysis provided for Time-averaged AUC of CD8+ T-cell Count in PBMCs

4. Secondary:

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. [ Time Frame: From start of study vaccination to week 37 ]

Measure Type	Secondary
Measure Title	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.
Measure Description	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.
Time Frame	From start of study vaccination to week 37
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	5	6	6
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. [units: spot-forming cells/10^6 PBMC] Median ( Inter-Quartile Range )	16441.8 ( 1896.1 to 37519.0 )	25797.0 ( 4708.3 to 46438.4 )	920.1 ( 133.6 to 4817.9 )	1760.4 ( 650.0 to 3122.9 )

No statistical analysis provided for 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.

5. Secondary:

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. [ Time Frame: From start of study vaccination to week 37 ]

Measure Type	Secondary
Measure Title	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.
Measure Description	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.
Time Frame	From start of study vaccination to week 37
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	5	6	6
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. [units: spot-forming cells/10^6 PBMC] Median ( Inter-Quartile Range )
gag p17	18779.2 ( 2232.8 to 25283.1 )	6653.5 ( 4282.8 to 7466.4 )	1422.0 ( 104.5 to 7798.8 )	3120.7 ( 1076.0 to 6756.2 )
gag p24	15691.4 ( 2351.1 to 89228.3 )	33446.0 ( 6903.0 to 77524.8 )	585.1 ( 244.8 to 1360.1 )	641.2 ( 292.7 to 1749.9 )
gag p15	17977.7 ( 723.8 to 23520.9 )	13921.4 ( 6206.1 to 60107.5 )	1163.5 ( 163.9 to 2340.1 )	2244.4 ( 91.5 to 3349.3 )
tat/rev	1272.0 ( 630.2 to 5226.8 )	2912.0 ( 2168.3 to 9518.1 )	268.3 ( 38.8 to 1149.9 )	712.8 ( 18.8 to 2035.2 )

No statistical analysis provided for 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.

6. Secondary:

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. [ Time Frame: From start of study vaccination to week 37 ]

Measure Type	Secondary
Measure Title	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.
Measure Description	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.
Time Frame	From start of study vaccination to week 37
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	6	6
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. [units: spot-forming cells/10^6 PBMC] Median ( Inter-Quartile Range )	421.8 ( 401.8 to 443.0 )	274.5 ( 134.0 to 784.1 )	214.2 ( 59.4 to 576.2 )	126.7 ( 68.7 to 145.3 )

No statistical analysis provided for 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.

7. Secondary:

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. [ Time Frame: From start of study vaccination to week 37 ]

Measure Type	Secondary
Measure Title	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.
Measure Description	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.
Time Frame	From start of study vaccination to week 37
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	6	6
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. [units: spot-forming cells/10^6 PBMC] Median ( Inter-Quartile Range )
gag p17	270.9 ( 130.0 to 364.7 )	186.5 ( 25.8 to 332.5 )	409.8 ( 159.8 to 1028.9 )	152.6 ( 57.8 to 234.1 )
gag p24	213.6 ( 113.0 to 795.9 )	458.4 ( 345.6 to 1999.4 )	135.3 ( 54.3 to 1193.5 )	103.8 ( 29.1 to 256.9 )
gag p15	141.5 ( 85.4 to 379.5 )	345.8 ( 31.5 to 386.1 )	31.0 ( 14.4 to 184.6 )	95.4 ( 35.0 to 277.5 )
tat/rev	7.9 ( 6.0 to 419.6 )	22.9 ( 5.9 to 174.6 )	31.7 ( 15.3 to 133.5 )	33.3 ( 7.0 to 55.3 )

No statistical analysis provided for 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.

8. Secondary:

Anti-dsDNA Antibody Response [ Time Frame: From start of study vaccination to week 61 ]

Measure Type	Secondary
Measure Title	Anti-dsDNA Antibody Response
Measure Description	Results report the number of participants who had negative anti-dsDNA antibody result at baseline and at week 17 or 61.
Time Frame	From start of study vaccination to week 61
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	6	6
Anti-dsDNA Antibody Response [units: participants]	5	6	6	6

No statistical analysis provided for Anti-dsDNA Antibody Response

9. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	5	6
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 [units: cells/mm3] Median ( Inter-Quartile Range )
p24	46.4 ( 44.8 to 91.7 )	21.5 ( 11.4 to 26.7 )	27.1 ( 13.2 to 32.3 )	13.0 ( 5.1 to 19.3 )
gag/pol/env	27.5 ( 12.5 to 36.7 )	9.2 ( 8.0 to 20.5 )	8.4 ( 7.8 to 22.2 )	16.8 ( 0.5 to 25.7 )
tat/rev	4.0 ( 1.1 to 14.2 )	4.0 ( 1.2 to 8.6 )	0.2 ( 0 to 0.3 )	10.1 ( 1.8 to 14.7 )

No statistical analysis provided for 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

10. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	3	6
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 [units: cells/mm^3] Median ( Inter-Quartile Range )	305.3 ( 19.5 to 328.3 )	68.6 ( 6.2 to 459.0 )	4.6 ( 0 to 28.9 )	6.0 ( 3.5 to 73.0 )

11. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	5	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 Anti-CD3 [units: cells/mm^3] Median ( Inter-Quartile Range )	333.6 ( 298.5 to 355.4 )	334.9 ( 210.4 to 548.6 )	200.4 ( 182.0 to 274.2 )	248.8 ( 213.4 to 293.3 )

12. Secondary:

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. [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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.
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	5	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. [units: percent] Median ( Inter-Quartile Range )
p24	10.0 ( 6.7 to 11.3 )	3.5 ( 1.2 to 4.6 )	4.9 ( 1.4 to 6.9 )	2.0 ( 0.7 to 3.1 )
gag/pol/env	4.3 ( 1.7 to 4.7 )	1.4 ( 1.1 to 2.2 )	1.8 ( 0.9 to 2.2 )	2.5 ( 0.1 to 3.7 )
tat/rev	0.6 ( 0.2 to 1.7 )	0.3 ( 0.1 to 1.9 )	0 ( 0 to 0.1 )	1.4 ( 0.2 to 1.8 )

No statistical analysis provided for 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.

13. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	3	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 Whole HIV-1 Antigen [units: percent] Median ( Inter-Quartile Range )	42.0 ( 3.0 to 64.8 )	10.6 ( 1.7 to 44.2 )	1.1 ( 0 to 7.1 )	0.9 ( 0.5 to 15.2 )

14. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	5	5
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 [units: percent] Median ( Inter-Quartile Range )	47.7 ( 41.3 to 51.8 )	37.4 ( 35.7 to 53.7 )	31.1 ( 31.1 to 38.3 )	48.5 ( 36.2 to 49.1 )

15. Secondary:

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. [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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.
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	5	5	6
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. [units: cells/mm^3] Median ( Inter-Quartile Range )
p24	10.5 ( 5.3 to 14.7 )	11.1 ( 3.5 to 12.0 )	1.0 ( 0.8 to 5.0 )	2.5 ( 0.8 to 5.1 )
gag/pol/env	88.7 ( 72.8 to 107.0 )	59.1 ( 34.4 to 68.4 )	38.2 ( 22.4 to 62.2 )	44.3 ( 31.6 to 49.4 )
tat/rev	2.5 ( 2.2 to 45.5 )	4.8 ( 1.7 to 17.1 )	5.7 ( 0.2 to 17.4 )	3.8 ( 1.6 to 6.1 )
HIV-1 MN	118.6 ( 43.9 to 169.0 )	120.3 ( 60.9 to 130.9 )	73.5 ( 53.3 to 111.9 )	89.7 ( 37.1 to 118.5 )

No statistical analysis provided for 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.

16. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	5	5	5
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 [units: cells/mm^3] Median ( Inter-Quartile Range )	330.6 ( 313.7 to 331.1 )	486.2 ( 458.6 to 727.9 )	350.4 ( 332.3 to 375.6 )	278.9 ( 222.2 to 449.4 )

17. Secondary:

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. [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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.
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	5	6
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. [units: percent] Median ( Inter-Quartile Range )
p24	2.1 ( 1.0 to 2.6 )	0.7 ( 0.4 to 1.4 )	0.1 ( 0.1 to 0.6 )	0.5 ( 0.1 to 0.7 )
gag/pol/env	14.3 ( 9.9 to 15.1 )	4.8 ( 1.5 to 7.4 )	6.0 ( 3.0 to 7.4 )	6.0 ( 5.2 to 11.7 )
tat/rev	0.5 ( 0.3 to 4.0 )	0.4 ( 0.2 to 1.0 )	1.1 ( 0 to 2.6 )	0.5 ( 0.3 to 0.7 )
HIV-1 MN	24.9 ( 7.5 to 26.0 )	7.5 ( 6.1 to 12.0 )	10.4 ( 7.0 to 16.5 )	15.4 ( 6.5 to 16.7 )

No statistical analysis provided for 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.

18. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	5	5
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 [units: percent] Median ( Inter-Quartile Range )	58.4 ( 57.5 to 62.7 )	54.3 ( 34.5 to 67.7 )	48.5 ( 43.2 to 63.9 )	53.5 ( 47.9 to 62.5 )

19. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	4	6
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 [units: cells/mm^3] Median ( Inter-Quartile Range )
HIV-1 MN	1.2 ( 0.7 to 1.4 )	0.3 ( 0 to 0.5 )	0.1 ( 0 to 0.3 )	0 ( 0 to 0 )
gag/pol/env	0.7 ( 0.7 to 1.0 )	0 ( 0 to 0.1 )	0.1 ( 0 to 0.3 )	0 ( 0 to 0.2 )
tat/rev	0.4 ( 0.3 to 0.8 )	0.3 ( 0.2 to 0.3 )	0 ( 0 to 0 )	0.2 ( 0 to 0.6 )
SEB	18.3 ( 17.4 to 21.7 )	24.2 ( 7.6 to 65.4 )	6.1 ( 4.7 to 23.5 )	10.4 ( 7.4 to 18.4 )

No statistical analysis provided for 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

20. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	4	6
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 [units: percent] Median ( Inter-Quartile Range )
HIV-1 MN	0.2 ( 0.1 to 0.2 )	0 ( 0 to 0.1 )	0 ( 0 to 0.1 )	0 ( 0 to 0 )
gag/pol/env	0.1 ( 0.1 to 0.2 )	0 ( 0 to 0 )	0 ( 0 to 0 )	0 ( 0 to 0.1 )
tat/rev	0.1 ( 0 to 0.1 )	0 ( 0 to 0.1 )	0 ( 0 to 0 )	0 ( 0 to 0.1 )
SEB	2.6 ( 2.2 to 2.9 )	3.6 ( 1.1 to 8.2 )	1.2 ( 1.0 to 3.7 )	2.0 ( 1.4 to 2.4 )

No statistical analysis provided for 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

21. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	5	4	6
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 [units: cells/mm^3] Median ( Inter-Quartile Range )
HIV-1 MN	0.4 ( 0 to 0.4 )	0.3 ( 0.2 to 0.5 )	0 ( 0 to 0.5 )	0 ( 0 to 0.1 )
gag/pol/env	3.1 ( 1.0 to 3.2 )	2.0 ( 1.9 to 10.5 )	1.0 ( 0.2 to 1.8 )	1.0 ( 0.1 to 2.0 )
tat/rev	2.2 ( 0.4 to 5.6 )	0.5 ( 0.5 to 1.2 )	0.3 ( 0.1 to 0.7 )	1.1 ( 0.6 to 1.9 )
SEB	19.2 ( 11.0 to 25.5 )	31.4 ( 25.0 to 35.9 )	32.2 ( 16.2 to 49.1 )	17.2 ( 9.4 to 30.6 )

No statistical analysis provided for 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

22. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	4	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 [units: percent] Median ( Inter-Quartile Range )
HIV-1 MN	0 ( 0 to 0.1 )	0 ( 0 to 0.1 )	0 ( 0 to 0.1 )	0 ( 0 to 0 )
gag/pol/env	0.5 ( 0.1 to 0.7 )	0.2 ( 0.2 to 0.6 )	0.2 ( 0.1 to 0.3 )	0.1 ( 0 to 0.3 )
tat/rev	0.3 ( 0.1 to 0.9 )	0.1 ( 0 to 0.3 )	0.1 ( 0 to 0.1 )	0.2 ( 0.1 to 0.3 )
SEB	4.0 ( 3.0 to 4.1 )	4.9 ( 1.7 to 6.0 )	5.1 ( 3.7 to 6.8 )	3.1 ( 2.8 to 3.3 )

No statistical analysis provided for 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

23. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	4	6
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 [units: cells/mm^3] Median ( Inter-Quartile Range )
HIV-1 MN	0.6 ( 0 to 0.6 )	0.1 ( 0.1 to 0.2 )	0 ( 0 to 0.7 )	0 ( 0 to 0.1 )
gag/pol/env	0.1 ( 0.1 to 0.3 )	0 ( 0 to 0.2 )	0 ( 0 to 0.1 )	0.1 ( 0 to 0.3 )
tat/rev	0.2 ( 0 to 0.4 )	0 ( 0 to 0.1 )	0 ( 0 to 0 )	0.1 ( 0 to 0.4 )
SEB	16.9 ( 10.6 to 17.6 )	13.6 ( 7.0 to 19.5 )	7.9 ( 5.0 to 11.5 )	12.7 ( 8.2 to 15.8 )

No statistical analysis provided for 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

24. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	4	6
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 [units: percent] Median ( Inter-Quartile Range )
HIV-1 MN	0.1 ( 0 to 0.1 )	0 ( 0 to 0 )	0 ( 0 to 0.1 )	0 ( 0 to 0 )
gag/pol/env	0 ( 0 to 0.1 )	0 ( 0 to 0 )	0 ( 0 to 0 )	0 ( 0 to 0 )
tat/rev	0 ( 0 to 0.1 )	0 ( 0 to 0 )	0 ( 0 to 0 )	0 ( 0 to 0.1 )
SEB	2.1 ( 1.9 to 2.2 )	1.9 ( 1.8 to 2.4 )	1.5 ( 1.1 to 1.8 )	2.1 ( 1.6 to 2.9 )

No statistical analysis provided for 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

25. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	5	4	6
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 [units: cells/mm^3] Median ( Inter-Quartile Range )
HIV-1 MN	0 ( 0 to 0.3 )	0.1 ( 0.1 to 0.3 )	0 ( 0 to 1.3 )	0.1 ( 0 to 0.1 )
gag/pol/env	0.3 ( 0 to 0.3 )	0.3 ( 0 to 0.5 )	0 ( 0 to 0.3 )	0 ( 0 to 0.1 )
tat/rev	0.3 ( 0.1 to 0.5 )	0 ( 0 to 0.2 )	0 ( 0 to 0.1 )	0 ( 0 to 0.1 )
SEB	1.9 ( 1.4 to 2.8 )	5.3 ( 3.4 to 9.2 )	4.2 ( 2.9 to 5.7 )	2.1 ( 1.1 to 3.5 )

No statistical analysis provided for 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

26. Secondary:

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 [ Time Frame: From start of study vaccination to week 24 ]

Measure Type	Secondary
Measure Title	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
Measure Description	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.
Time Frame	From start of study vaccination to week 24
Safety Issue	No

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Reporting Groups

	Description
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.

Measured Values

	A: 0.1 mg DNA/Participant Vaccination at Weeks 1, 7, 13	C: 0.4 mg DNA/Participant Vaccination at Weeks 1, 7, 13	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13	Placebo
Number of Participants Analyzed [units: participants]	5	6	4	6
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 [units: percent] Median ( Inter-Quartile Range )
HIV-1 MN	0 ( 0 to 0 )	0 ( 0 to 0 )	0 ( 0 to 0.2 )	0 ( 0 to 0 )
gag/pol/env	0.1 ( 0 to 0.1 )	0 ( 0 to 0.1 )	0 ( 0 to 0 )	0 ( 0 to 0 )
tat/rev	0 ( 0 to 0.1 )	0 ( 0 to 0.1 )	0 ( 0 to 0 )	0 ( 0 to 0 )
SEB	0.3 ( 0.3 to 0.4 )	0.5 ( 0.3 to 1.5 )	0.7 ( 0.4 to 1.4 )	0.3 ( 0.2 to 0.5 )

No statistical analysis provided for 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

27. Secondary:

Lymphocyte Proliferation Stimulation Index (SI) in Response to Whole HIV-1 Antigen, p24 Antigen, and Pooled HIV-1 Peptide Antigens [ Time Frame: Throughout study ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

28. Secondary:

Breadth of HIV-1-specific Immune Response, as Determined by the Number of Overlapping HIV-1 Peptides for Which the ELISPOT Assay for IFN-gamma Production is Observed to Have Five or More Spot-forming Cells/ 10^5 PBMCs [ Time Frame: Throughout study ]

Results not yet posted. Anticipated Posting Date: No text entered. Safety Issue: No

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed. Restriction Description: 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.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
This is a Phase I/II small sample study that was not powered for the secondary efficacy endpoints.

Results Point of Contact:

Name/Title: Clinicaltrials.gov Coordinator
Organization: Center for Biostatistics in AIDS Research, Harvard School of Public Health
phone: (617)432-2829
e-mail: CBAR.ClinicalTrials.Gov@sdac.harvard.edu

Publications:

Lisziewicz J, Trocio J, Xu J, Whitman L, Ryder A, Bakare N, Lewis MG, Wagner W, Pistorio A, Arya S, Lori F. Control of viral rebound through therapeutic immunization with DermaVir. AIDS. 2005 Jan 3;19(1):35-43.

Lori F, Trocio J, Bakare N, Kelly LM, Lisziewicz J. DermaVir, a novel HIV immunisation technology. Vaccine. 2005 Mar 18;23(17-18):2030-4.

Lori F, Weiner DB, Calarota SA, Kelly LM, Lisziewicz J. Cytokine-adjuvanted HIV-DNA vaccination strategies. Springer Semin Immunopathol. 2006 Nov;28(3):231-8. Epub 2006 Oct 20.

Rajcani J, Mosko T, Rezuchova I. Current developments in viral DNA vaccines: shall they solve the unsolved? Rev Med Virol. 2005 Sep-Oct;15(5):303-25. Review.

Cristillo AD, Lisziewicz J, He L, Lori F, Galmin L, Trocio JN, Unangst T, Whitman L, Hudacik L, Bakare N, Whitney S, Restrepo S, Suschak J, Ferrari MG, Chung HK, Kalyanaraman VS, Markham P, Pal R. HIV-1 prophylactic vaccine comprised of topical DermaVir prime and protein boost elicits cellular immune responses and controls pathogenic R5 SHIV162P3. Virology. 2007 Sep 15;366(1):197-211. Epub 2007 May 11.

Lisziewicz J, Trocio J, Whitman L, Varga G, Xu J, Bakare N, Erbacher P, Fox C, Woodward R, Markham P, Arya S, Behr JP, Lori F. DermaVir: a novel topical vaccine for HIV/AIDS. J Invest Dermatol. 2005 Jan;124(1):160-9.

Lisziewicz J, Rosenberg E, Lieberman J, Jessen H, Lopalco L, Siliciano R, Walker B, Lori F. Control of HIV despite the discontinuation of antiretroviral therapy. N Engl J Med. 1999 May 27;340(21):1683-4. No abstract available.

Calarota SA, Foli A, Maserati R, Baldanti F, Paolucci S, Young MA, Tsoukas CM, Lisziewicz J, Lori F. HIV-1-specific T cell precursors with high proliferative capacity correlate with low viremia and high CD4 counts in untreated individuals. J Immunol. 2008 May 1;180(9):5907-15.

Gudmundsdotter L, Wahren B, Haller BK, Boberg A, Edback U, Bernasconi D, Butto S, Gaines H, Imami N, Gotch F, Lori F, Lisziewicz J, Sandstrom E, Hejdeman B. Amplified antigen-specific immune responses in HIV-1 infected individuals in a double blind DNA immunization and therapy interruption trial. Vaccine 29(33):5558-5566, 2011.

Responsible Party:	National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:	NCT00270205 History of Changes
Other Study ID Numbers:	A5176, 10126, ACTG A5176
Study First Received:	December 21, 2005
Results First Received:	September 7, 2011
Last Updated:	May 17, 2012
Health Authority:	United States: Food and Drug Administration

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