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

International AIDS Vaccine Initiative

Status and phase: Completed; Phase 1

Conditions: HIV Infections

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

Study type: Interventional

Funder types: NETWORK; Industry

Identifiers

NCT01496989

IAVI B004

Details and patient eligibility

About

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.

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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75 participants in 5 patient groups

Group 1: HIV-MAG followed by Ad35-GRIN/ENV

Experimental group

Description:

HIV-MAG (IM/EP) at Months 0,1,2 followed by Ad35-GRIN/ENV (IM) at Month 6. (Vaccine:Placebo = 12/3)

Treatment:

Biological: Ad35-GRIN/ENV

Biological: HIV-MAG (3,000mcg)

Group 2: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV

Experimental group

Description:

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)

Treatment:

Biological: Ad35-GRIN/ENV

Biological: GENEVAX® IL-12 (100mcg)

Biological: HIV-MAG (3,000mcg)

Group 3: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV

Experimental group

Description:

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)

Treatment:

Biological: GENEVAX® IL-12 (1000mcg)

Biological: Ad35-GRIN/ENV

Biological: HIV-MAG (3,000mcg)

Group 4: HIV-MAG+GENEVAX® IL-12 followed by Ad35-GRIN/ENV

Experimental group

Description:

HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 0 followed by Ad35-GRIN/ENV (IM) at Month 4. (Vaccine:Placebo=12/3)

Treatment:

Biological: GENEVAX® IL-12 (1000mcg)

Biological: Ad35-GRIN/ENV

Biological: HIV-MAG (3,000mcg)

Group 5: Ad35-GRIN/ENV followed by HIV-MAG+GENEVAX® IL-12

Experimental group

Description:

Ad35-GRIN/ENV (IM) at Month 0 followed by HIV-MAG + GENEVAX® IL-12 (IM/EP) at Month 4. (Vaccine:Placebo=12/3)

Treatment:

Biological: GENEVAX® IL-12 (1000mcg)

Biological: Ad35-GRIN/ENV

Biological: HIV-MAG (3,000mcg)