Investigators at Saint Louis University propose to transition our research on HIV vaccine development as an AVEU to the HVTN. A dedicated and experienced team of investigators and staff will contribute to the research agenda of the HVTN through work with the Vaccine Leadership Group (VLG) and through protocol development and implementation. Investigators at SLU have an excellent track record at volunteer recruitment and retention, innovation in dealing with volunteers' safety issues (such as antibody positivity after vaccination), full compliance with protocols, efficient reporting of data to the network, timely publication of results, and strong basic science research related to HIV vaccine immune responses This application summarizes our track record to date and key findings from our phase I and phase II studies of HIV vaccines. In parallel we have conducted research on the reasons why minorities may be reluctant to participate in clinical studies, and this proposal describes our success at overcoming some obstacles to minority recruiting. This proposal summarizes the results of phase II studies in higher risk groups and describes ongoing studies to select the most immunogenic canarypox vector for larger clinical trials. These larger trials will obtain preliminary data on efficacy on live vectors expressing HIV antigens vs. subunit vaccines vs. both live vector and subunit vaccines vs. placebo. These studies will provide us with the opportunity to assess possible immune correlates of protection from HIV. We summarize phase I protocol development for newer vaccines including vectors or polynucleotide vaccines. A point by point discussion of the 15 requirements set forth in this RFA summarizes our approach to significant regulatory and human studies issues, the organization and mission of the SLU Community Advisory Board, and the quality assurance plan of this unit. We conclude with a description of a potential expansion site at UIC for phase III studies in women at high risk from heterosexual transmission. This mode of transmission is less prevalent in the US than in developing nations and we believe this expansion site will enhance the HVTN's ability to pilot studies for international phase III trials, as well as contribute large numbers of subjects to phase III trials.
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