ESSENTIAL CORE ACTIVITIES, NIAID PRECLIN DEVELOPMENT SUPPORT

该合同的目的是为人类临床试验提供HIV-1预防疫苗原型的所有方面的开发、制造、IND支持的临床前测试和管理文件的制作。这包括所有类型的HIV-1疫苗，包括DNA质粒、病毒载体和蛋白质抗原。这些能力将使NIAID能够更快、更有效地弥合艾滋病毒疫苗的开发和生产差距。活动将是小规模生产、临床前测试和文档编制，导致研究新药(IND)提交第一阶段、第二阶段和第三阶段临床测试。活动包括协助识别、测试和开发产品；参与和管理临床前测试，包括体外实验室测试、免疫原性测试、疗效研究和使用实验室动物的毒理学测试；以及利用GMP生产方案生产有前景的产品。此外，承包商还应维护产品库存，提供质量保证和质量控制，提供适当的法规文件，并开发和管理跟踪产品临床前发展的数据库。

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.