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HIV RESEARCH
HIV Overview | Cohort Study | ISHED  | Vaccine Study | Therapeutic Study

RV 172: A phase I/II Clinical trial to evaluate the safety and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine (VRC- HIVDNA016-00-VP), boosted by a multiclade HIV-1 Recombinant Adenovirus-5 vector vaccine, VRC HIVADV014-00-VP in HIV uninfected adult volunteers in East Africa. 

The United States Military HIV Research Program’s (USMHRP) first HIV vaccine study to be conducted in Kenya opened in Kericho in April 2006 and is fully enrolled. This study is a phase I/II clinical trial to evaluate the safety and immunogenicity of a multiclade HIV-1 DNA plasmid vaccine boosted by a multiclade HIV-1 recombinant adenovirus-5 vector vaccine in HIV uninfected adult volunteers in East Africa.

The phase I component of RV 172 is focused on a research oriented question: The safety and immunogenicity of two dose levels of rAd5 in participants with a broad range of preexisting Ad5 antibodies with or without DNA priming. The triad studies are powered to detect small differences in safety and immunogenicity between vaccine and placebo arms.

The phase II studies are powered individually to detect small differences in immunogenicity between the vaccine and placebo arms.

RV 172 is the first USMHRP HIV vaccine study to be conducted in Kenya and is part of the triad study conducted with HVTN 204 and IAVI-001. The vaccine was developed at the Vaccine Research Centre (VRC). The study aims to qualify the six plasmid multiclade HIV-1 DNA plasmid vaccine boosted by a multiclade recombinant adenovirus-5 vector (rAd5) vaccine for efficacy trials. Protocol development is on-going for a Proof of Concept trial for the two products i.e. PAVE 100. 

HIV VACCINE STUDY

 

 

 

 

 

  The Clinical research Centre Kericho where the Vaccine Study is being curried out

The study opened on April 07, 2006 and is fully enrolled with 120 participants. This makes RV 172 study the first HIV vaccine study to be conducted outside of Nairobi and the largest HIV vaccine study ever conducted in Kenya. Recruitment was smooth and faster than projected and retention thus far is 100% over the course of 5 months into the study.

 
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