HIV Infections Clinical Trial
Official title:
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
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Prevention
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