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IAVI B004

Phase:
I
Status:
Ongoing
Strategies:
DNA, Viral Vector - Adeno
Candidates:
HIV-MAG+GENEVAX® IL-12, Ad35-GRIN/ENV
Countries:
Kenya;Uganda;Rwanda
Volunteers:
75
Partners:
Kenya AIDS Vaccine Initiative (KAVI-Kangemi)-Kangemi, Kenya; Projet San Francisco (PSF-Kigali)-Kigali, Rwanda; Uganda Virus Research Institute-International AIDS Vaccine Initiative (UVRI-IAVI), Entebbe, Uganda; Profectus BioSciences Inc.; Ichor Medical Systems.

 
Study Summary:
 
The study is a randomized, double-blind placebo-controlled trial assessing the safety and immunogenicity of a multi-antigen HIV (HIV-MAG) plasmid DNA (pDNA) vaccine co-administered with recombinant human IL-12 pDNA (GENEVAX® IL-12) given intramuscularly by in vivo electroporation (IM/EP) using the Ichor Medical Systems TriGrid Delivery System (TDS-IM), followed or preceded by recombinant Ad35-GRIN/ENV HIV vaccine. This study will recruit HIV-uninfected, healthy volunteers. Approximately 75 volunteers (60 vaccine/15 placebo recipients) will be included in the study.