TOPICAL MICROBICIDE SAFETY AND EFFICACY EVALUATION

外用杀菌剂的安全性和功效评估

基本信息

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
项目类别：
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

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

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项目摘要

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.

该副本是利用资源的众多研究子项目之一由NIH/NCRR资助的中心赠款提供。对该子弹的主要支持而且，副投影的主要研究员可能是其他来源提供的包括其他NIH来源。列出的总费用可能代表subproject使用的中心基础架构的估计量， NCRR赠款不直接向子弹或副本人员提供的直接资金。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。