Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety, tolerability and immunogenicity of multiantigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine in low-risk for HIV-uninfected healthy adults.

Detailed Description
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The study is a randomized, double-blind placebo-controlled trial assessing the safety and tolerability of HIV-MAG with or without co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM) followed by Ad35-GRIN/ENV in each of four different regimens. An additional group will evaluate the safety and tolerability of Ad35-GRIN/ENV followed by HIV-MAG with co-administered GENEVAX® IL-12 given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM). Volunteers will be screened up to 42 days before the 1st vaccination and will be followed for 12 months after the first vaccine administration. It is anticipated that it will take approximately 3 months to enrol the study. Approximately 75 volunteers (60 vaccine/15 placebo recipients) will be included in the study.

Official Title
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A Phase 1 Double-Blind, Randomized, Placebo-Controlled Trial to Evaluate Safety and Immunogenicity of a Multiantigen HIV (HIV-MAG) pDNA Vaccine With or Without Human IL-12 pDNA GENEVAX® IL-12) and Ad35-GRIN/ENV Vaccine in HIV-Uninfected, Healthy Volunteers

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: HIV-MAG (3,000mcg)
* Biological: GENEVAX® IL-12 (100mcg)
* Biological: GENEVAX® IL-12 (1000mcg)
* Biological: Ad35-GRIN/ENV


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy male or female adults, 18 to 50 years of age (21 to 50 years of age for volunteers in Rwanda), who do not report high-risk behaviour for HIV infection, who are available for the duration of the trial, who are willing to undergo HIV testing, use an effective method of contraception, and who, in the opinion of the principal investigator or designee, understand the study and who provide written informed consent. Principal exclusion criteria: confirmed HIV infection, pregnancy and lactation, significant acute or chronic disease, clinically significant laboratory abnormalities, recent vaccination or receipt of a blood product, previous receipt of an HIV vaccine, and previous severe local or systemic reactions to vaccination or history of severe allergic reactions.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group 1: HIV-MAG followed by Ad35-GRIN/ENV<br>HIV-MAG (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo = 12/3) | Biological: HIV-MAG (3,000mcg)<br>* Delivered intramuscularly by in vivo electroporation<br>Biological: Ad35-GRIN/ENV<br>* (2x10^10vp) Delivered intramuscularly by standard needle injection<br>|
| Experimental: Group 2: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV<br>HIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo=12/3) | Biological: HIV-MAG (3,000mcg)<br>* Delivered intramuscularly by in vivo electroporation<br>Biological: GENEVAX® IL-12 (100mcg)<br>* Co-administered with HIV-MAG, delivered intramuscularly by in vivo electroporation<br>Biological: Ad35-GRIN/ENV<br>* (2x10^10vp) Delivered intramuscularly by standard needle injection<br>|
| Experimental: Group 3: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV<br>HIV-MAG + GENEVAX® IL-12 (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo= 12/3) | Biological: HIV-MAG (3,000mcg)<br>* Delivered intramuscularly by in vivo electroporation<br>Biological: GENEVAX® IL-12 (1000mcg)<br>* Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation<br>Biological: Ad35-GRIN/ENV<br>* (2x10^10vp) Delivered intramuscularly by standard needle injection<br>|
| Experimental: Group 4: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV<br>HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 0 followed by Ad35-GRIN/ENV (IM) at Month 4. (Vaccine:Placebo=12/3) | Biological: HIV-MAG (3,000mcg)<br>* Delivered intramuscularly by in vivo electroporation<br>Biological: GENEVAX® IL-12 (1000mcg)<br>* Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation<br>Biological: Ad35-GRIN/ENV<br>* (2x10^10vp) Delivered intramuscularly by standard needle injection<br>|
| Experimental: Group 5: Ad35-GRIN/ENV followed by HIV-MAG+GENEVAX® IL-12<br>Ad35-GRIN/ENV (IM) at Month 0 followed by HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 4. (Vaccine:Placebo=12/3) | Biological: HIV-MAG (3,000mcg)<br>* Delivered intramuscularly by in vivo electroporation<br>Biological: GENEVAX® IL-12 (1000mcg)<br>* Co-administered with HIV-MAG, delivered intramuscular by in vivo electroporation<br>Biological: Ad35-GRIN/ENV<br>* (2x10^10vp) Delivered intramuscularly by standard needle injection<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as a measure of safety and tolerability | To evaluate the safety and tolerability of HIV-MAG, GENEVAX® IL-12, and Ad35-GRIN/ENV administered in five heterologous prime-boost regimens. | 13 months approximately | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity | To assess (qualitative and quantitative) immune responses elicited by the different prime-boost regimens. | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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HIV, AIDS, HIV vaccine, HIV prevention