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Global HIV Vaccine Development

The VRC has developed a prime-boost strategy using a multiclade DNA plasmid vaccine for prime vaccination and a recombinant adenoviral vector vaccine (rAd5) for booster vaccination. These three studies, referred to as the Triad studies, have completed enrollment of approximately 900 volunteers at multiple sites in the United States and internationally and are being conducted by the NIAID HIV Vaccine Trials Network (HVTN), the US Military HIV Research Program (USMHRP), and the International AIDS Vaccine Initiative (IAVI). HVTN has study sites in the United States, South Africa, Jamaica, Haiti, and Brazil; USMHRP has study sites in Kenya, Uganda, and Tanzania; and IAVI has study sites in Rwanda and Kenya.

These studies are providing data to support initiation of a test-of-concept Phase IIB efficacy study that will be conducted under the auspices of the Partnership for AIDS Vaccine Evaluation (PAVE). This Phase IIB efficacy trial, PAVE 100A, has been proposed for 2008 and would be designed to test whether the VRC candidate DNA/rAd5 prime-boost vaccination regimen can prevent acquisition of infection or progression of disease (using viral load as a surrogate marker) in those who become infected. PAVE 100A would be designed to enroll several thousand volunteers in two studies focused on distinct populations in the Americas and Africa at sites sponsored by HVTN, USMHRP, IAVI, and the Centers for Disease Control and Prevention (CDC). Immune assays for the Phase II and IIB studies will be undertaken at NVITAL, a NIAID-supported immune assay facility. Immunogenicity testing of Triad HIV Phase I/II trial samples would support the design of PAVE 100A.

Additionally, if the vaccine proves effective, researchers will study immune correlates of protection using newly developed immune assays. Successful identification of such immune correlates would greatly accelerate development of improved HIV vaccines.

NIH Press Release - October 11, 2005
NIAID Launches First Phase II Trial of a "Global" HIV/AIDS Vaccine