NIAID Preclinical Development Support - Development of clade C Vaccine

NIAID 临床前开发支持 - 进化枝 C 疫苗的开发

• 批准号: 9526954
• 负责人: PHILLIP ISHIKAWA
• 金额: $ 47.98万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2012
• 资助国家: 美国
• 起止时间: 2012-09-27 至 2018-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9526954
• 关键词: AIDS prevention; Contracts; Development; Documentation; Guidelines; HIV; HIV vaccine; Investigational Drugs; Investigational New Drug Application; Investigator-Initiated Research; Modality; National Institute of Allergy and Infectious Disease; Pamphlets; Phase; Preclinical Testing; Process; Production; Protocols documentation; Research Personnel; Safety; Testing; Vaccines; authority; flexibility; immunogenicity; microbicide; preclinical development; research clinical testing; research study

This contract will provide NIAID with a broad and flexible range of nontraditional, proactive and developmentally-oriented capabilities to provide preclinical development support for promising products when such products emerge from investigator-initiated research studies. These capabilities will allow NIAID to more rapidly and efficiently close development and production gaps. Activities include but are not limited to small-scale production, preclinical testing and documentation leading to Investigational New Drug (IND) submission for Phase I, II, and III clinical testing. The primary aim is for the development of a Ad4 1086 HIV Clade C envelope vaccine.

该合同将为NIAID提供广泛而灵活的非传统、前瞻性和发展导向的能力，当这些产品从研究者发起的研究中出现时，为有前途的产品提供临床前开发支持。这些能力将使NIAID能够更快、更有效地缩小开发和生产差距。活动包括但不限于小规模生产，临床前测试和导致新药研究（IND）提交I， II和III期临床测试的文件。主要目的是开发一种ad41086 HIV Clade C包膜疫苗。