TOPICAL MICROBICIDE SAFETY AND EFFICACY EVALUATION

该子项目是利用资源的许多研究子项目之一 由NIH/NCRR资助的中心赠款提供。次级项目的主要支助 子项目的主要研究者可能是由其他来源提供的， 包括其它NIH来源。 列出的子项目总成本可能 代表子项目使用的中心基础设施的估计数量， 而不是由NCRR赠款提供给子项目或子项目工作人员的直接资金。 这些研究的目的是利用我们建立的局部杀微生物剂安全性和有效性评价模型，通过在非人灵长类动物（NHP）中进行临床前试验，进一步开发旨在预防和控制性传播感染（STI）的局部杀微生物剂。本实验室目前可使用沙眼衣原体和阴道毛滴虫的猕猴模型进行疗效研究。NIAID提供的所有试验产品将首先通过重复阴道内或直肠内产品应用完成安全性评价。具有可接受的安全性特征的产品可入组（经NIAID批准）涉及一种或多种STI的疗效研究。安全性指标包括微生物学和pH值评估以及通过阴道镜评价或直肠灌洗评估证明的粘膜组织反应记录。有效性取决于产品预防挑战病原体感染的能力。

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. The objective of these studies is to further the development of topical microbicides aimed at the prevention and control of sexually transmitted infections (STIs) through preclinical testing in nonhuman primates (NHP), utilizing our established models for topical microbicide safety and efficacy evaluations. Macaque models of Chlamydia trachomatis and Trichomonas vaginalis are currently available for efficacy studies in this laboratory. All test products, provided by NIAID, will first complete safety evaluation with repeated intravaginal or intrarectal product application. Products with acceptable safety profiles may be enrolled (with NIAID approval) to efficacy studies involving one or more STI. Safety measures include microbiologic and pH assessments and documentation of mucosal tissue responses as evidenced by colposcopic evaluation or rectal lavage assessment. Efficacy is determined by a product's ability to prevent infection by the challenge pathogen.