IMPROVED MACAQUE SAFETY MODEL FOR TOPICAL MICROBICIDES: POST-COITAL ASSESSMENTS

改进的猕猴外用杀菌剂安全模型：性交后评估

• 批准号: 8357592
• 负责人: DOROTHY L PATTON
• 金额: $ 24.64万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2011
• 资助国家: 美国
• 起止时间: 2011-05-01 至 2012-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8357592
• 关键词: Characteristics; Colposcopy; Consent; Contracts; Data; Development; Environment; Evaluation; Exogenous Factors; Female; Funding; Gel; Grant; HIV; Local Microbicides; Macaca; Macaca nemestrina; Measures; Modeling; Monitor; National Center for Research Resources; Partner in relationship; Placebos; Prevention strategy; Primates; Principal Investigator; Property; Research; Research Infrastructure; Resources; Safety; Seminal fluid; Sex Behavior; Sexually Transmitted Diseases; Source; United States National Institutes of Health; Vagina; cohort; cost; improved; preclinical safety; response; transmission process

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. Primary support for the subproject and the subproject's principal investigator may have been provided by other sources, including other NIH sources. The Total Cost listed for the subproject likely represents the estimated amount of Center infrastructure utilized by the subproject, not direct funding provided by the NCRR grant to the subproject or subproject staff. Topical microbicides represent an emerging strategy for the prevention of transmission of HIV and other sexually transmitted infections. A successful topical microbicide product will be applied prior to intercourse, without necessitating partner consent, and will be active against a variety of STIs, including HIV. It will be acceptable to potential users in terms of physical characteristics, availability, ease of use, safety and efficacy properties. We have utilized the macaque vaginal safety model (currently contracted by the NIH, HHSN266200700013C) to provide standardized preclinical safety data for numerous topical microbicide products in development. In the contract model, measures of product safety include cervicovaginal colposcopy, vaginal microbiologic evaluation, and vaginal pH monitoring. The model characterizes the vaginal environment's response to repeated topical product applications in the absence of the exogenous factors of intercourse and potentially infectious ejaculate. With this project, we have enhanced our standardized vaginal safety evaluations conducted in the pigtailed macaque model to include evaluations after sexual activity and with the presence of seminal fluid. With continued funding, we are collecting baseline data from a large cohort of female macaques assessing the cervicovaginal environment before and after mating. In addition, we are collecting parallel pre- and post-coital assessments, with a placebo gel (HEC universal placebo) in place. These studies provide urgently needed data regarding topical microbicide use with coital activity.

该子项目是利用资源的众多研究子项目之一 由 NIH/NCRR 资助的中心拨款提供。子项目的主要支持 并且子项目的首席研究员可能是由其他来源提供的， 包括其他 NIH 来源。 子项目可能列出的总成本 代表子项目使用的中心基础设施的估计数量， NCRR 赠款不直接向子项目或子项目工作人员提供资金。 外用杀菌剂代表了预防艾滋病毒和其他性传播感染传播的新兴策略。成功的外用杀菌剂产品将在性交前使用，无需伴侣同意，并且可有效对抗多种性传播感染，包括艾滋病毒。它在物理特性、可用性、易用性、安全性和功效特性方面将被潜在用户所接受。 我们利用猕猴阴道安全模型（目前由 NIH 签约，HHSN266200700013C）为正在开发的众多外用杀菌剂产品提供标准化的临床前安全数据。在合同模式中，产品安全措施包括宫颈阴道阴道镜检查、阴道微生物评估和阴道pH监测。该模型描述了在没有性交和潜在感染性射精的外源因素的情况下，阴道环境对重复局部产品应用的反应。 通过这个项目，我们加强了在猪尾猕猴模型中进行的标准化阴道安全评估，包括性活动后和精液存在下的评估。 在持续的资助下，我们正在收集一大群雌性猕猴的基线数据，评估交配前后的子宫颈阴道环境。此外，我们正在收集平行的性交前和性交后评估，并使用安慰剂凝胶（HEC 通用安慰剂）。 这些研究提供了关于性交活动中局部杀菌剂使用的迫切需要的数据。