Safety and Immunogenicity Study of HIV-MAG Vaccine +/- IL-12 and Ad35-GRIN/ENV in HIV-uninfected Volunteers
HIV Infections
About this trial
This is an interventional prevention trial for HIV Infections focused on measuring HIV, AIDS, HIV vaccine, HIV prevention
Eligibility Criteria
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.
Sites / Locations
- Kenya AIDS Vaccine Initiative, Kangemi
- Projet San Francisco
- Uganda Virus Research Institute-IAVI
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Experimental
Experimental
Experimental
Experimental
Experimental
Group 1: HIV-MAG followed by Ad35-GRIN/ENV
Group 2: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
Group 3: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
Group 4: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV
Group 5: Ad35-GRIN/ENV followed by HIV-MAG+GENEVAX® IL-12
HIV-MAG (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo = 12/3)
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)
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)
HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 0 followed by Ad35-GRIN/ENV (IM) at Month 4. (Vaccine:Placebo=12/3)
Ad35-GRIN/ENV (IM) at Month 0 followed by HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 4. (Vaccine:Placebo=12/3)