TOPICAL MICROBICIDE SAFETY AND EFFICACY EVALUATION

外用杀菌剂的安全性和功效评估

• 批准号: 8172749
• 负责人: DOROTHY L PATTON
• 金额: $ 46.53万
• 依托单位: UNIVERSITY OF WASHINGTON
• 依托单位国家: 美国
• 财政年份: 2010
• 资助国家: 美国
• 起止时间: 2010-05-01 至 2011-04-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8172749
• 关键词: Chlamydia trachomatis; Computer Retrieval of Information on Scientific Projects Database; Development; Documentation; Enrollment; Evaluation; Funding; Grant; Infection prevention; Institution; Irrigation; Laboratories; Local Microbicides; Macaca; Measures; Modeling; Mucous Membrane; National Institute of Allergy and Infectious Disease; Preclinical Testing; Prevention; Research; Research Personnel; Resources; Safety; Sexually Transmitted Diseases; Source; Testing; Trichomonas vaginalis; United States National Institutes of Health; 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. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. 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.

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这些研究的目的是进一步开发旨在通过非人类灵长类动物（NHP）进行临床前测试来预防和控制性传播感染（STI）的局部杀菌剂，利用了我们既定的局部微生物安全性和功效评估模型。目前可以在该实验室进行疗效研究，可用于沙眼衣原体和阴道的猕猴模型。所有由NIAID提供的测试产品将首先通过重复的内后或直肠内部产品应用完成安全评估。具有可接受的安全性概况的产品可能会纳入涉及一个或多个STI的疗效研究（NIAID批准）。安全措施包括微生物学和pH评估以及粘膜组织反应的记录，如阴道镜评估或直肠灌洗评估所证明。功效取决于产品防止挑战病原体感染的能力。