NIAID Preclinical Development Support: Adjuvants for HIV-1 Vaccines

NIAID 临床前开发支持：HIV-1 疫苗佐剂

• 批准号: 10806903
• 负责人: THOMAS VANCOTT
• 金额: $ 26.54万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-01 至 2023-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10806903
• 关键词: Adjuvant; Antigens; Chemistry; Clinical Trials; Contractor; Contracts; Data; Databases; Development; Documentation; Equipment and supply inventories; Formulation; Good Manufacturing Process; HIV vaccine; HIV-1; Human; In Vitro; Investigational Drugs; Laboratories; Laboratory Animals; Manufacturer; Methods; National Institute of Allergy and Infectious Disease; Pamphlets; Phase; Preclinical Testing; Preventive vaccine; Production; Proteins; Protocols documentation; Quality Control; Records; Research Personnel; Testing; Toxicology; Vaccines; Viral Vector; efficacy study; immunogenicity; manufacture; manufacturing process; plasmid DNA; preclinical development; product development; prototype; quality assurance; research clinical testing

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.

该合同的目的是提供用于人体临床试验的原型 HIV-1 预防性疫苗的开发、制造、临床前测试 IND 以及监管文件制作的各个方面。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 能够更快速、更有效地缩小 HIV 疫苗的开发和生产差距。活动将包括小规模生产、临床前测试和文件记录，从而提交研究性新药 (IND) 以进行 I、II 和 III 期临床测试。活动包括协助产品的识别、测试和开发；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、功效研究和使用实验动物的毒理学测试；并利用 GMP 生产协议生产有前景的产品。此外，承包商还应维护产品库存，提供质量保证和质量控制，提供适当的监管文件，并开发和管理跟踪产品临床前开发的数据库。