Feasibility Assessment of HIV Env Protein Antigens

HIV包膜蛋白抗原的可行性评估

• 批准号: 9567366
• 负责人: ANTU DEY
• 金额: $ 45.04万
• 依托单位: INTERNATIONAL AIDS VACCINE INITIATIVE
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-09-18 至 2018-09-17
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9567366
• 关键词: Antigens; Basic Science; Chemistry; Clinic; Clinical Trials; Contracts; Development; HIV; HIV Infections; HIV vaccine; Immunology; Investigational New Drug Application; Molecular Biology; National Institute of Allergy and Infectious Disease; Phase; Process; Proteins; Vaccines; assay development; env Gene Products; 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. The primary activity will be to conduct feasibility assessments of HIV Env protein antigens.

NIAID 为 HIV 疫苗开发提供流程开发和分析支持：开发预防 HIV 感染传播的疫苗是国家过敏和传染病研究所 (NIAID) 的首要任务之一。尽管免疫学和分子生物学的进步继续为新疫苗/产品的开发提供越来越多的方法，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。为了弥补转化开发方面的差距，NIAID 特别建议支持两个关键组成部分：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（第 2 阶段和第 3 阶段）期间作为产品开发/化学、制造和控制 (CMC) 活动的一部分继续进行。参与产品开发活动（制造工艺开发和优化、分析表征和化验开发）旨在促进潜在 HIV 蛋白疫苗在 1、2 和 3 期临床试验中的进展。 主要活动是对 HIV 包膜蛋白抗原进行可行性评估。