Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) (U19)

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Purpose. The goal of this Funding Opportunity Announcement (FOA) issued by the National Institute of Allergy and Infectious Diseases (NIAID) is to facilitate the translation of innovative and promising basic science-derived vaccine concepts for prophylactic HIV vaccines to initial clinical trials by providing the critical resources necessary for achieving this goal. The Integrated Preclinical/Clinical AIDS Vaccine Development Program (IPCAVD) is a mechanism that enables investigators to conduct clinical research studies aimed at addressing specific scientific questions and vaccine concepts most appropriately tested in humans. To fulfill this goal, an IPCAVD award is intended to provide assistance to meritorious competitive projects in 3 areas: (1) support for basic hypothesis-driven science to advance development of the vaccine concept by facilitating non-human primate (NHP) proof-of-concept studies and down-selection to the best lead candidate; (2) access to resources for determining whether the vaccine concept is clinically feasible by determining whether a candidate vaccine successfully addresses FDA requirements for performing clinical testing, by determining the feasibility of manufacturing cGMP lots of the vaccine and by determining vaccine safety by conducting the required toxicology and pharmacology safety studies; and (3) support for the initial human clinical study central to addressing the proposed scientific question. A preclinical research project application alone is not appropriate for this announcement. Mechanism of Support. This FOA will utilize the multi-project Cooperative Agreement (U19) award mechanism. Funds Available and Anticipated Number of Awards. NIAID anticipates that approximately $3.2 million total costs will be available in FY2011 to fund 1-2 new or renewal wards in response to this FOA.

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