TOPICAL MICROBICIDE SAFETY AND EFFICACY EVALUATION

外用杀菌剂的安全性和功效评估

• 批准号: 8357591
• 负责人: DOROTHY L PATTON
• 金额: $ 37.79万
• 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/8357591
• 关键词: Chlamydia trachomatis; Development; Documentation; Enrollment; Evaluation; Funding; Grant; Infection prevention; Irrigation; Laboratories; Local Microbicides; Macaca; Measures; Modeling; Mucous Membrane; National Center for Research Resources; National Institute of Allergy and Infectious Disease; Preclinical Testing; Prevention; Primates; Principal Investigator; Research; Research Infrastructure; Resources; Safety; Sexually Transmitted Diseases; Source; Testing; Trichomonas vaginalis; United States National Institutes of Health; cost; efficacy evaluation; nonhuman primate; pathogen; rectal; response

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.

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。 这些研究的目的是利用我们建立的外用杀菌剂安全性和功效评估模型，通过在非人类灵长类动物 (NHP) 中进行临床前测试，进一步开发旨在预防和控制性传播感染 (STI) 的外用杀菌剂。沙眼衣原体和阴道毛滴虫的猕猴模型目前可用于本实验室的功效研究。 NIAID 提供的所有测试产品将首先通过反复阴道内或直肠内产品应用来完成安全性评估。具有可接受的安全性的产品可以参加（经 NIAID 批准）涉及一种或多种性传播感染的功效研究。安全措施包括微生物学和 pH 值评估以及通过阴道镜评估或直肠灌洗评估证明的粘膜组织反应记录。功效取决于产品预防挑战病原体感染的能力。