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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HIV Infections
- Sponsor
- International AIDS Vaccine Initiative
- Enrollment
- 75
- Locations
- 3
- Primary Endpoint
- Number of participants with adverse events as a measure of safety and tolerability
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
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
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.
Investigators
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,
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Number of participants with adverse events as a measure of safety and tolerability
Time Frame: 13 months approximately
To evaluate the safety and tolerability of HIV-MAG, GENEVAX® IL-12, and Ad35-GRIN/ENV administered in five heterologous prime-boost regimens.
Secondary Outcomes
- Immunogenicity(12 months)