Ovine Model and Vaginal Microbiome Support for HIV Non-vaccine Biomedical Prevention Product Development

绵羊模型和阴道微生物组支持 HIV 非疫苗生物医学预防产品开发

• 批准号: 10704975
• 负责人: GLENN SWARTZ
• 金额: $ 0.67万
• 依托单位: ADVANCED BIOSCIENCE LABORATORIES, INC.
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-02-01 至 2018-01-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10704975
• 关键词: AIDS prevention; Acquired Immunodeficiency Syndrome; Clinical Trials; Development; Devices; Drug Kinetics; Evaluation; HIV; HIV Infections; Investigation; Investigational Drugs; Licensure; Modeling; National Institute of Allergy and Infectious Disease; Pathway interactions; Persons; Play; Prevention; Prevention strategy; Preventive vaccine; Resources; Role; Safety; Services; Sheep; Technology; United States Food and Drug Administration; United States National Institutes of Health; Work; anti-HIV microbicide; microbicide; novel therapeutics; pre-clinical; pre-exposure prophylaxis; prevent; product development; research clinical testing; sexual HIV transmission; sheep model; vaginal microbiome

Comprehensive Resources for HIV Microbicides and Biomedical Prevention: The development of highly effective HIV prevention strategies, including a preventive vaccine and other non-vaccine biomedical prevention (nBP) products, remains one of the highest priorities for the Division of AIDS (DAIDS) and the National Institute of Allergy and Infectious Diseases (NIAID) at the National Institutes of Health (NIH). With current global HIV infection estimates exceeding 33 million people, the development of safe, effective, and acceptable nBP products to prevent the sexual transmission of HIV could play a major role in the worldwide reduction of the estimated 5000 new HIV infections per day. As promising nBP products emerge (e.g., microbicides, pre-exposure prophylaxis (PrEP) agents, and Multipurpose Prevention Technologies (MPT’s), there is a critical need to rapidly and efficiently move these candidates into clinical testing. The scope of work encompasses preclinical activities that range from initial product discovery to those required to support clinical trials and/or product licensure. This project will utilize ovine and vaginal microbiome models to support the development of HIV nBPs.

HIV杀菌剂和生物医学预防的综合资源：发展高效的HIV预防策略，包括预防性疫苗和其他非疫苗生物医学预防（NBP）产品，仍然是艾滋病（DAIDS）（daids）的最高优先事项之一（daids）和国家疾病研究所（Nationuial Diseases）（Niaiaide）（NIAIADITITITE）的最高优先事项之一。随着当前的全球艾滋病毒感染估计超过3,300万人，安全，有效且可接受的NBP产品以防止艾滋病毒的性传播的发展可能在世界上每天减少5000种新的HIV感染中发挥重要作用。随着有前途的NBP产品的出现（例如，菌皮，暴露前预防（PREP）药物和预防技术（MPT），迫切需要将这些候选者迅速移动到临床测试中，这些候选者范围从最初的临床范围内进行了临床范围，这些范围包括这些临床范围的临床范围或对临床范围进行的临床试验，并涉及这些临床范围或对临床范围的临床范围进行试验。椭圆形和阴道微生物组模型，以支持HIV NBP的发展。