NIAID Process Development and Analytical Support for Development of HIV Vaccines

NIAID 为 HIV 疫苗开发提供流程开发和分析支持

• 批准号: 10244793
• 负责人: THOMAS HASSELL
• 金额: $ 26.06万
• 依托单位: INTERNATIONAL AIDS VACCINE INITIATIVE
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-07-15 至 2021-07-14
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10244793
• 关键词: Basic Science; Chemistry; Clinic; Clinical Trials; Contracts; Development; Documentation; HIV; HIV Infections; HIV vaccine; Immunology; Investigational New Drug Application; Molecular Biology; National Institute of Allergy and Infectious Disease; Phase; Process; Proteins; Reagent; Reporting; Shipping; Vaccines; assay development; manufacturing process development; novel vaccines; prevent; product development; vaccine development

NIAID Process Development and Analytical Support for Development of HIV Vaccines: The development of vaccines to prevent the spread of HIV infection is among the National Institute of Allergy and Infectious Diseases (NIAID) highest priorities. While advances in immunology and molecular biology continue to offer an expanding array of approaches for the development of new vaccines/products, there is limited capacity and expertise for translational development to move basic research findings into the clinic. To bridge the gap in translational development, NIAID specifically proposes to support two key critical components: process development and analytical characterization activities. This contract will provide targeted specialized expertise and facilities for process development and analytic characterization. These activities are initiated prior to filing an Investigational New Drug (IND) application and continue as part of product development/chemistry, manufacturing, and control (CMC) activities during ongoing clinical trials (Phase 2 and 3). Access to product development activities (manufacturing process development and optimization, analytical characterization and assay development) is intended to facilitate the progression of potential HIV protein vaccines in Phase 1, 2, and 3 clinical trials.

NIAID艾滋病毒疫苗开发过程开发和分析支持：预防艾滋病毒感染传播的疫苗开发是国家过敏和传染病研究所（NIAID）的最高优先事项之一。虽然免疫学和分子生物学的进步继续为新疫苗/产品的开发提供了不断扩大的方法，但将基础研究成果转化为临床的转化开发能力和专业知识有限。为了弥合转化开发中的差距，NIAID特别提出支持两个关键的关键组成部分：工艺开发和分析表征活动。该合同将为工艺开发和分析表征提供有针对性的专业知识和设施。这些活动在提交研究性新药（IND）申请之前启动，并在正在进行的临床试验（II期和III期）期间继续作为产品开发/化学、生产和控制（CMC）活动的一部分。参与产品开发活动（生产工艺开发和优化、分析表征和检测开发）旨在促进潜在HIV蛋白疫苗在I、II和III期临床试验中的进展。