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

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ClinicalTrials.gov Identifier: NCT00270205
Recruitment Status : Completed
First Posted : December 26, 2005
Results First Posted : October 13, 2011
Last Update Posted : January 10, 2018
Sponsor:
Collaborator:
AIDS Clinical Trials Group
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Care Provider, Investigator);   Primary Purpose: Treatment
Condition HIV Infections
Interventions Biological: LC002 standard vaccination
Biological: LC002 high-dose vaccination
Biological: LC002 placebo vaccination
Enrollment 28
Recruitment Details 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 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.
Arm/Group Title 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
Hide Arm/Group Description 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. 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. 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. All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Period Title: Overall Study
Started 6 6 [1] 6 7
Completed 5 6 6 6
Not Completed 1 0 0 1
Reason Not Completed
Lost to Follow-up             1             0             0             1
[1]
7 participants enrolled. One never started study vaccination and was excluded from all analyses.
Arm/Group Title 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
Hide Arm/Group Description 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. 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. 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. 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 of all reporting groups
Overall Number of Baseline Participants 6 6 6 7 25
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous   [1] 
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
44
(32 to 48)
41
(38 to 43)
46
(34 to 47)
34
(30 to 35)
39
(32 to 45)
[1]
Measure Description: Age (in years) at study entry. Participants who never started study vaccination were excluded.
Age, Customized   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
18-30 1 1 1 2 5
31-40 2 2 1 5 10
41-50 3 3 4 0 10
[1]
Measure Description: Age (in years) at study entry. Participants who never started study vaccination were excluded.
Sex: Female, Male   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
Female
1
  16.7%
0
   0.0%
0
   0.0%
1
  14.3%
2
   8.0%
Male
5
  83.3%
6
 100.0%
6
 100.0%
6
  85.7%
23
  92.0%
[1]
Measure Description: Participants who never started study vaccination were excluded.
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 6 participants 6 participants 6 participants 7 participants 25 participants
6 6 6 7 25
1.Primary Outcome
Title Percent of Participants With Primary Safety Endpoint
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study treatment/vaccination were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 6 6 6 7
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of participants
0
(0 to 40.2)
0
(0 to 40.2)
0
(0 to 40.2)
0
(0 to 37.7)
2.Secondary Outcome
Title Time-averaged Area Under the Curve (AUC) of CD4+ T-cell Count in PBMCs
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 4 5 5
Median (Inter-Quartile Range)
Unit of Measure: cells/mm3
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)
3.Secondary Outcome
Title Time-averaged AUC of CD8+ T-cell Count in PBMCs
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 4 5 5
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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)
4.Secondary Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 5 6 6
Median (Inter-Quartile Range)
Unit of Measure: spot-forming cells/10^6 PBMC
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)
5.Secondary Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 5 6 6
Median (Inter-Quartile Range)
Unit of Measure: spot-forming cells/10^6 PBMC
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)
6.Secondary Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 6 6
Median (Inter-Quartile Range)
Unit of Measure: spot-forming cells/10^6 PBMC
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)
7.Secondary Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 6 6
Median (Inter-Quartile Range)
Unit of Measure: spot-forming cells/10^6 PBMC
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)
8.Secondary Outcome
Title Anti-dsDNA Antibody Response
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 6 6
Measure Type: Number
Unit of Measure: participants
5 6 6 6
9.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 5 6
Median (Inter-Quartile Range)
Unit of Measure: cells/mm3
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)
10.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 3 6
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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 Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 5 5
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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 Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 5 6
Median (Inter-Quartile Range)
Unit of Measure: percent
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)
13.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 3 6
Median (Inter-Quartile Range)
Unit of Measure: percent
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 Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 5 5
Median (Inter-Quartile Range)
Unit of Measure: percent
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 Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 5 5 6
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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)
16.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 5 5 5
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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 Outcome
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.
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 5 6
Median (Inter-Quartile Range)
Unit of Measure: percent
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)
18.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through week 24 were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 5 5
Median (Inter-Quartile Range)
Unit of Measure: percent
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 Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 4 6
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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)
20.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 4 6
Median (Inter-Quartile Range)
Unit of Measure: percent
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)
21.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 5 4 6
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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)
22.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 4 6
Median (Inter-Quartile Range)
Unit of Measure: percent
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)
23.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 4 6
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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)
24.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 4 6
Median (Inter-Quartile Range)
Unit of Measure: percent
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)
25.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 5 4 6
Median (Inter-Quartile Range)
Unit of Measure: cells/mm^3
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)
26.Secondary Outcome
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
Hide 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Only those participants who started study vaccination and who have complete and non-missing responses through 24 weeks were included in the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 5 6 4 6
Median (Inter-Quartile Range)
Unit of Measure: percent
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)
27.Secondary Outcome
Title Lymphocyte Proliferation Stimulation Index (SI) in Response to Whole HIV-1 Antigen, p24 Antigen, and Pooled HIV-1 Peptide Antigens
Hide Description 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.
Time Frame From start of study vaccination to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There are no data available for the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
28.Other Pre-specified Outcome
Title 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
Hide Description 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.
Time Frame From start of study vaccination to week 24
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
There are no data available for the analysis.
Arm/Group Title 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
Hide Arm/Group Description:
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.
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.
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.
All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
Overall Number of Participants Analyzed 0 0 0 0
No data displayed because Outcome Measure has zero total analyzed.
Time Frame From start of study vaccination to week 61
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 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
Hide Arm/Group Description 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. 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. 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. All participants receiving vaccinations of LC002 placebo were combined together in this arm/group. This includes those participants in arms B, D and F.
All-Cause Mortality
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/7 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/6 (0.00%)   0/6 (0.00%)   0/6 (0.00%)   0/7 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
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
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   5/6 (83.33%)   6/6 (100.00%)   6/6 (100.00%)   6/7 (85.71%) 
Blood and lymphatic system disorders         
Lymphadenopathy  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Eye disorders         
Eye pain  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Lacrimation decreased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Macular degeneration  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Gastrointestinal disorders         
Abdominal distension  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Abdominal pain  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%) 
Abdominal pain lower  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Diarrhoea  1  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  1/7 (14.29%) 
Hiatus hernia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Nausea  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Proctalgia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Rectal ulcer  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Vomiting  1  1/6 (16.67%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%) 
General disorders         
Chills  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Fatigue  1  1/6 (16.67%)  1/6 (16.67%)  0/6 (0.00%)  2/7 (28.57%) 
Injection site discomfort  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Injection site erythema  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  3/7 (42.86%) 
Injection site mass  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Injection site pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Injection site pruritus  1  3/6 (50.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Malaise  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Oedema peripheral  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Pain  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Pyrexia  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Vaccination site erythema  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Vaccination site pain  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%) 
Vaccination site reaction  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Infections and infestations         
Hordeolum  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Secondary syphilis  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Vaginitis bacterial  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Injury, poisoning and procedural complications         
Burns second degree  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Investigations         
Alanine aminotransferase increased  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Aspartate aminotransferase increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Blood bicarbonate  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Blood bilirubin increased  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/7 (14.29%) 
Blood creatine phosphokinase increased  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Blood creatinine increased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Blood glucose abnormal  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  0/7 (0.00%) 
Blood glucose decreased  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  1/7 (14.29%) 
Blood phosphorus decreased  1  2/6 (33.33%)  1/6 (16.67%)  1/6 (16.67%)  1/7 (14.29%) 
Blood sodium decreased  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Weight decreased  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%) 
Metabolism and nutrition disorders         
Decreased appetite  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Hypoglycaemia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Musculoskeletal and connective tissue disorders         
Arthralgia  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Back pain  1  0/6 (0.00%)  0/6 (0.00%)  3/6 (50.00%)  0/7 (0.00%) 
Groin pain  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Muscle spasms  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Myalgia  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Pain in extremity  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  0/7 (0.00%) 
Nervous system disorders         
Amnesia  1  1/6 (16.67%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Burning sensation  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  1/7 (14.29%) 
Dizziness  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  2/7 (28.57%) 
Dysgeusia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Headache  1  0/6 (0.00%)  1/6 (16.67%)  1/6 (16.67%)  1/7 (14.29%) 
Paraesthesia  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Psychiatric disorders         
Anxiety  1  0/6 (0.00%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Insomnia  1  1/6 (16.67%)  0/6 (0.00%)  1/6 (16.67%)  0/7 (0.00%) 
Respiratory, thoracic and mediastinal disorders         
Cough  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/7 (0.00%) 
Nasal congestion  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/7 (0.00%) 
Oropharyngeal pain  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Productive cough  1  0/6 (0.00%)  1/6 (16.67%)  0/6 (0.00%)  0/7 (0.00%) 
Respiratory tract congestion  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Upper respiratory tract congestion  1  0/6 (0.00%)  2/6 (33.33%)  0/6 (0.00%)  0/7 (0.00%) 
Skin and subcutaneous tissue disorders         
Alopecia areata  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Erythema  1  2/6 (33.33%)  2/6 (33.33%)  4/6 (66.67%)  3/7 (42.86%) 
Lipoatrophy  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Papule  1  0/6 (0.00%)  0/6 (0.00%)  2/6 (33.33%)  0/7 (0.00%) 
Pruritus  1  1/6 (16.67%)  1/6 (16.67%)  6/6 (100.00%)  3/7 (42.86%) 
Rash  1  0/6 (0.00%)  0/6 (0.00%)  0/6 (0.00%)  1/7 (14.29%) 
Rash macular  1  1/6 (16.67%)  1/6 (16.67%)  1/6 (16.67%)  1/7 (14.29%) 
Rash papular  1  0/6 (0.00%)  1/6 (16.67%)  2/6 (33.33%)  0/7 (0.00%) 
1
Term from vocabulary, MedDRA 14.0
Indicates events were collected by systematic assessment
This is a Phase I/II small sample study that was not powered for the secondary efficacy endpoints.
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.
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.
Results Point of Contact
Name/Title: ACTG Clinicaltrials.gov Coordinator
Organization: ACTG Network Coordinating Center, Social and Scientific Systems, Inc.
Phone: (301) 628-3313
Publications of Results:
Natz E, Lisziewicz J. Rational Design of Formulated DNA Vaccines: The DermaVir Approach. In J. Thalhamer, R. Weiss & S. Scheiblhofer (Eds.), Gene Vaccines. In press.
Other Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00270205     History of Changes
Other Study ID Numbers: A5176
10126 ( Registry Identifier: DAIDS ES )
ACTG A5176
First Submitted: December 21, 2005
First Posted: December 26, 2005
Results First Submitted: September 7, 2011
Results First Posted: October 13, 2011
Last Update Posted: January 10, 2018