Safety, Tolerability and Immune Response to LC002, an Exp... | NCT00270205

ID	Type	Description	Link
10126	Registry Identifier	DAIDS ES
ACTG A5176

Name	Class
Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections	NETWORK

Description Module

Detailed Description

The use of highly active antiretroviral therapy (HAART) has dramatically improved the rates of survival, morbidity, and mortality among HIV-infected people throughout the world. However, the costs, long-term toxicity, and problems with adherence associated with HAART regimens make such treatment plans less than optimal for individuals seeking treatment for HIV infection. Also, because viral reservoirs cannot be eradicated, HIV-infected people must usually be on HAART indefinitely in order to keep their infection under control. While the mechanism is still unclear, the immune system weakens as HIV disease progresses. A therapeutic HIV vaccine given to HIV infected people may help to promote better immune responses. LC002 is a novel HIV therapeutic vaccine containing a DNA plasmid that codes for most of HIV-1's proteins. LC002 is a unique vaccine in that it is given through topical administration; this allows for Langerhans cells (immune cells located under the surface of the skin) to pick up the vaccine and deliver it to the lymph nodes, causing an immune reaction. This study evaluated the safety, tolerability, and immunogenicity of LC002 in HIV-infected adults currently receiving HAART.

There were three cohorts in this study which were enrolled sequentially. Participants in a given cohort were randomly assigned to receive either LC002 (6 participants) or placebo (2 participants).

In Cohort 1, participants received three separate low-dose vaccinations of LC002 (Arm A: 0.1 mg DNA/participant, 0.8 ml total, administered over two skin sites of 80 cm^2 each, 0.4 ml/site) or 3 separate vaccinations of placebo (Arm B: 0.8 ml total, administered over two skin sites of 80 cm^2 each, 0.4 ml/site). Vaccinations were given over two skin sites on the left and right upper back. Participants received vaccinations at weeks 1, 7, and 13.
In Cohort 2, participants received three separate high-dose vaccinations of LC002 (Arm C: 0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites of 80 cm^2 each, 0.8 ml/site) or three separate vaccinations of placebo (Arm D: 3.2 ml total, administered over four skin sites of 80 cm^2 each, 0.8 ml/site). Vaccinations were given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants received vaccinations at weeks 1, 7, and 13.
In Cohort 3, participants received six separate high-dose vaccinations of LC002 (Arm E: 0.4 mg DNA/participant, 3.2 ml total, administered over four skin sites of 80 cm^2 each, 0.8 ml/site) or six vaccinations of placebo (Arm F: 3.2 ml total, administered over four skin sites of 80 cm^2 each, 0.8 ml/site). Vaccinations were given over four skin sites on the left and right upper back and left and right upper ventral thigh. Participants received vaccinations at study entry and weeks 1, 6, 7, 12, and 13.

The decision to open the next cohort was made when all participants in the current cohort have remained on study for >=14 days after the second vaccination or prematurely discontinued from study or had a primary safety endpoint (see primary outcome measure definition). Dose escalation required no primary safety endpoint and on-study follow-up for >=6 participants in the previous cohort(s).

Prior to receiving the vaccine, the chosen vaccine administration site on the back or thigh was disinfected and exfoliated. A skin patch was applied to the site, and the vaccine solution was placed on the skin underneath the patch with a needleless syringe. Participants were allowed to remove the skin patch 3 hours post vaccination. For the first and second vaccinations, participants were required to remain at the clinic for 3 hours post-vaccination so study staff can assess for side effects. If no side effects occurred after the first two vaccinations, participants were required to stay at the clinic for only 30 minutes after receiving later vaccinations.

At the start of the study, participants were asked to keep a diary and record daily any side effects or skin irritation they may have experienced following vaccination. Participants were required to bring their diaries with them to their next clinic visit. Two days after vaccination, participants were followed-up by phone and were asked about any side effects they may have experienced. Participants who experienced side effects were asked to return to the clinic for examination. There were 13 study visits; they occurred at study entry and Weeks 1, 3, 6, 7, 9, 12, 13, 15, 17, 24, 37, and 61. Study visits included medication history, a physical exam, and collection of diaries. Blood and urine collection occurred at selected visits. HAART was not be provided by the study.

Label	Type	Description	Intervention Names
A: 0.1 mg DNA/participant vaccination at weeks 1,7,13	Experimental	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.	Biological: LC002 standard vaccination
B	Experimental	Participants receiving three separate vaccinations of LC002 placebo (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.	Biological: LC002 placebo vaccination
C: 0.4 mg DNA/participant vaccination at weeks 1, 7, 13	Experimental	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.	Biological: LC002 high-dose vaccination
D	Experimental	Participants receiving three separate vaccinations of LC002 placebo (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.	Biological: LC002 placebo vaccination

Name	Type	Description	Arm Group Labels	Other Names
LC002 standard vaccination	Biological	0.1 mg DNA/participant, 0.8 ml total administered subcutaneously	A: 0.1 mg DNA/participant vaccination at weeks 1,7,13

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

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

Measure	Description	Time Frame
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	Additional outcome measure for possible supportive exploratory analysis. The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

HIV-1-infected
On a stable HAART regimen without changes or interruptions for more than 4 consecutive days for at least 12 weeks prior to study entry. Patients must be currently taking regimens containing drugs of at least two different classes.
Two readings of plasma HIV-1 viral load of less than 50 copies/ml within 30 days prior to study entry. More information on this criterion can be found in the protocol.
CD4 count greater than 350 cells/mm^3 within 12 weeks prior to study entry
Lowest CD4 count greater than 250 cells/mm^3 at any time prior to study entry
Willing to use acceptable forms of contraception
Karnofsky performance score 90 or higher obtained within 30 days prior to study entry

Exclusion Criteria:

HIV-1 viral load greater than 500 copies/ml within the 24 weeks prior to study entry
History of or current active skin disease (e.g., atopic dermatitis, psoriasis) or any chronic autoimmune disease (e.g., Graves' disease). Participants with minor, localized skin conditions that, in the opinion of the investigator, do not represent a safety concern, are not excluded.
Treatment with topical corticosteroids at the proposed vaccination sites (Cohort 1: left and right upper back; Cohorts 2 and 3: left and right upper back and left and right upper ventral thigh) within 2 weeks of study entry
Excessive exposure to the sun (e.g., sunbathing, tanning bed) within 2 weeks prior to study entry
Laser hair removal within 2 weeks prior to study entry
Use of any local skin treatments (e.g., topical/chemical hair removal, ointments, possible irritants) to the targeted vaccination sites within 7 days prior to study entry
History of diabetes or bleeding disorders
Previous CDC Category C event. More information on this criterion can be found in the protocol.
Use of immunomodulating therapy, including cyclosporine, IgG-containing products, interleukins, interferons, or systemic glucocorticosteroids (including those inhaled) within 6 months prior to study entry
Exposure to an experimental HIV vaccine within 6 months prior to study entry
Any vaccine within 30 days prior to study entry
Investigational products within 12 weeks prior to study entry
Allergy or sensitivity to study vaccine products, adhesives, or polyester
Current drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with the study
Serious illness requiring systemic treatment and/or hospitalization. Participants who complete therapy or are clinically stable on therapy for at least 14 days prior to study entry are not excluded.
Positive hepatitis B surface antigen or positive anti-hepatitis C antibody at screening
History of treatment with HAART during primary infection
History of lymph node irradiation
Pregnant or breastfeeding
Certain abnormal laboratory results. More information on this criterion can be found in the protocol

Name	Affiliation	Role
Benigno Rodriguez, MD	Division of Infectious Diseases ACTU, University Hospital of Cleveland, Cleveland, OH, USA	Study Chair

Facility	Status	City	State	ZIP	Country	Contacts
Univ. of California Davis Med. Ctr., ACTU		Sacramento	California	95814	United States
Chicago Children's CRS

PubMed Identifier	Type	Citation	Retractions
15627031	Background	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. doi: 10.1097/00002030-200501030-00004.
15755566	Background	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. doi: 10.1016/j.vaccine.2005.01.004.

ID	Title	Description
FG000	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.
FG001

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Percent of Participants With Primary Safety Endpoint

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.

Only those participants who started study treatment/vaccination were included in the analysis.

Posted

Number

95% Confidence Interval

percentage of participants

From start of study vaccination to 28 days after the last study vaccination

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.
OG003	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.

Units	Counts
Participants	OG0006 OG0016 OG0026 OG003

Title

Denominators

Categories

Title	Measurements
	OG0000(0 to 40.2) OG0010(0 to 40.2) OG0020(0 to 40.2) OG003

Secondary

Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs

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.

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.

Posted

Median

Inter-Quartile Range

cells/mm3

From start of study vaccination to week 61

ID	Title	Description
OG000	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.
OG001	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.
OG002	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13

Secondary

Time-averaged AUC of CD8+ T-cell Count in PBMCs

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.

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.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 61

ID	Title	Description
OG000	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.
OG001	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.
OG002	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13

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.

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.

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.

Posted

Median

Inter-Quartile Range

spot-forming cells/10^6 PBMC

From start of study vaccination to week 37

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

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.

Posted

Median

Inter-Quartile Range

spot-forming cells/10^6 PBMC

From start of study vaccination to week 37

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

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.

Posted

Median

Inter-Quartile Range

spot-forming cells/10^6 PBMC

From start of study vaccination to week 37

ID	Title	Description
OG000	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.
OG001	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.

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.

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.

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.

Posted

Median

Inter-Quartile Range

spot-forming cells/10^6 PBMC

From start of study vaccination to week 37

ID	Title	Description
OG000	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.
OG001	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.

Secondary

Anti-dsDNA Antibody Response

Results report the number of participants who had negative anti-dsDNA antibody result at baseline and at week 17 or 61.

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.

Posted

Number

participants

From start of study vaccination to week 61

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

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

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.

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

cells/mm3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

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.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

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.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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.

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13

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.

Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13

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.

Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

cells/mm^3

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

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

Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.

Posted

Median

Inter-Quartile Range

percent

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002

Secondary

Lymphocyte Proliferation Stimulation Index (SI) in Response to Whole HIV-1 Antigen, p24 Antigen, and Pooled HIV-1 Peptide Antigens

The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.

There are no data available for the analysis.

Posted

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002	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.

Other Pre-specified

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

Additional outcome measure for possible supportive exploratory analysis. The assay was not run due to published data showing that this assay is less sensitive than the PHPC assays (used in secondary outcomes 4 and 5). There are no data available for the analysis.

There are no data available for the analysis.

Posted

From start of study vaccination to week 24

ID	Title	Description
OG000	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.
OG001	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.
OG002	E: 0.4 mg DNA/Participant Vaccination at Weeks 0,1,6,7,12,13

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymphadenopathy	Blood and lymphatic system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG0030 affected7 at risk
Eye pain	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Lacrimation decreased	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Macular degeneration	Eye disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Abdominal distension	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Abdominal pain	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Abdominal pain lower	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Diarrhoea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0022 affected6 at risk EG003
Hiatus hernia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Nausea	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Proctalgia	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Rectal ulcer	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Vomiting	Gastrointestinal disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Chills	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Fatigue	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Injection site discomfort	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Injection site erythema	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Injection site mass	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Injection site pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Injection site pruritus	General disorders	MedDRA 14.0	Systematic Assessment	EG0003 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Malaise	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Oedema peripheral	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Pyrexia	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Vaccination site erythema	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Vaccination site pain	General disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Vaccination site reaction	General disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Hordeolum	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Secondary syphilis	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Vaginitis bacterial	Infections and infestations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Burns second degree	Injury, poisoning and procedural complications	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Alanine aminotransferase increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Aspartate aminotransferase increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Blood bicarbonate	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Blood bilirubin increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Blood creatine phosphokinase increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Blood creatinine increased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Blood glucose abnormal	Investigations	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Blood glucose decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0020 affected6 at risk EG003
Blood phosphorus decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0002 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Blood sodium decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Weight decreased	Investigations	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Decreased appetite	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Hypoglycaemia	Metabolism and nutrition disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Arthralgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Back pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0023 affected6 at risk EG003
Groin pain	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Muscle spasms	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Myalgia	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Pain in extremity	Musculoskeletal and connective tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Amnesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Burning sensation	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Dizziness	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Dysgeusia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Headache	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Paraesthesia	Nervous system disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Anxiety	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Insomnia	Psychiatric disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0010 affected6 at risk EG0021 affected6 at risk EG003
Cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0020 affected6 at risk EG003
Nasal congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0020 affected6 at risk EG003
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Productive cough	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0020 affected6 at risk EG003
Respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Upper respiratory tract congestion	Respiratory, thoracic and mediastinal disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0012 affected6 at risk EG0020 affected6 at risk EG003
Alopecia areata	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Erythema	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0002 affected6 at risk EG0012 affected6 at risk EG0024 affected6 at risk EG003
Lipoatrophy	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Papule	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0022 affected6 at risk EG003
Pruritus	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0026 affected6 at risk EG003
Rash	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0010 affected6 at risk EG0020 affected6 at risk EG003
Rash macular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0001 affected6 at risk EG0011 affected6 at risk EG0021 affected6 at risk EG003
Rash papular	Skin and subcutaneous tissue disorders	MedDRA 14.0	Systematic Assessment	EG0000 affected6 at risk EG0011 affected6 at risk EG0022 affected6 at risk EG003

ID	Term
D000086982	Blood-Borne Infections
D003141	Communicable Diseases
D007239	Infections
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D016180	Lentivirus Infections
D012192	Retroviridae Infections
D012327	RNA Virus Infections
D014777	Virus Diseases
D000091662	Genital Diseases
D000091642	Urogenital Diseases
D007153	Immunologic Deficiency Syndromes
D007154	Immune System Diseases

ID	Term
D016233	Immunotherapy, Active
D007114	Immunization
D007167	Immunotherapy
D056747	Immunomodulation
D001691	Biological Therapy
D013812	Therapeutics
D007158	Immunologic Techniques
D008919	Investigative Techniques
D011322	Primary Prevention
D011314	Preventive Health Services
D006296	Health Services
D005159	Health Care Facilities Workforce and Services
D003140	Communicable Disease Control
D015980	Public Health Practice
D011634	Public Health
D004778	Environment and Public Health

ID	Title	Description
BG000	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.
BG001	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.
BG002	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.
BG003	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.
BG004	Total	Total of all reporting groups

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	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.	6	6	5	6
EG001	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.	6	6	6	6
EG002	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.	6	6	6	6
EG003	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.	7	7	6	7