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RV 172: HIV Vaccine Study HIV Overview | HIV ProgramsRV 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 RV172 will be the first HIV vaccine study under WRAIR in Kenya. RV 172 is also being conducted by two other networks as identical studies within their respective networks: HVTN 204 and IAVI-001. These studies are being sponsored by the Vaccine Research Center (VRC), U.S. National Institute of Allergy and Infectious Diseases (NIAID) of the U.S. National Institutes of Health (NIH) in effort to qualify their six-plasmid multiclade HIV-1 DNA vaccine boosted by a multiclade HIV-1 recombinant adenovirus-5 vector (rAd5) vaccine for future efficacy trials. The Phase I component will be focused on traditional safety and immunogenicity related to two dose levels of rAd5 in participants with a broad range of preexisting Ad5 antibody titers, with and without prior DNA priming. The Phase II studies are incorporate 3 prime doses of the multiclade HIV vaccine followed by the rAd4 boost and are powered to detect small differences in immunogenicity between the vaccine and placebo arms. RV 172 is being conducted by the USMHRP network as a multicentre study involving 324 healthy HIV-1 uninfected adult volunteers (186 receiving vaccine and 138 receiving placebo) enrolled in three sites in East Africa (US Army Medical Research Unit- Kenya/Kenya Medical Research Institute, Kericho, Kenya; Mbeya Medical Research Program (MMRP), Mbeya, Tanzania; and, Makerere University/Walter Reed Project, Kampala, Uganda. Volunteers will be followed up for a duration of 14-16 months. The study is anticipated to open in early 2006.
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