ESSENTIAL CORE ACTIVITIES, NIAID PRECLIN DEVELOPMENT SUPPORT

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The purpose of this contract is to provide all aspects of the development, manufacture, IND enabling preclinical testing, and the production of regulatory documents for prototype HIV-1 prophylactic vaccines for human clinical trials. This includes all types of HIV-1 vaccines including DNA plasmids, viral vectors, and protein antigens. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps for HIV vaccines. Activities would be for he small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. Activities include assisting in the identification, testing, and development of products; participation in and managing preclinical testing including in vitro laboratory testing, immunogenicity testing, efficacy studies, and toxicology testing using laboratory animals; and utilize GMP production protocols to produce promising products. Furthermore, the Contractor shall also maintain inventories of products, provide quality assurance and quality control, provide the appropriate regulatory documentation, and develop and manage a database that tracks the preclinical development of the products.