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Development of a Live Topical Microbicide for Women

女性外用活杀微生物剂的开发

基本信息

批准号：
8126267
负责人：
Laurel A. Lagenaur
金额：
$ 36.45万
依托单位：
OSEL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2007
资助国家：
美国
起止时间：
2007-09-30 至 2013-08-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/8126267
关键词：
Address Adherence Animals Antibiotic Resistance Antibiotics Bacteria Bacterial Vaginosis Biological Markers Biological Products Biomedical Engineering Cell Line Cervical Chinese People Chromosomes Coculture Techniques Collection Consultations Cyanovirin-N Development Dose Drug Evaluation Drug Formulations Epidemiologic Studies Epithelial Cells Epithelium Evaluation Research Female Generations Genetic Genetically Modified Organisms Genital system Genome Stability HIV HIV Entry Inhibitors HIV-1 Heterosexuals Human Human Volunteers Hydrogen Hydrogen Peroxide Immune In Situ Infection Investigational Drugs Investigational New Drug Application Lactobacillus Lead Life Local Microbicides Macaca mulatta Modeling Opportunistic Infections Organism Pharmacologic Substance Phase Phase II Clinical Trials Proteins Recombinants Recurrence Risk Safety Seminal Plasma Sexually Transmitted Diseases Therapeutic Transference United States Dept. of Health and Human Services Urinary tract infection Vagina Viral Woman Work base design immunogenicity immunotoxicity manufacturing process microbicide nonhuman primate novel pathogen pre-clinical preclinical efficacy preclinical safety preclinical study prevent self-renewal simian human immunodeficiency virus transmission process vaginal lactobacilli volunteer

项目摘要

This proposal outlines the development of a novel live microbicide, termed MucoCept, designed to prevent heterosexual HIV transmission in women. MucoCept is an H2O2- producing vaginal L. jensenii 1153 strain that has been genetically modified to constitutively secrete a potent anti-HIV protein, cyanovirin-N (CV-N). We propose to assess the safety, tolerability and affect on innate genital tract immune factor and colonization following application of a CV-N expressing L. jensenii designated 1153- 1666 using the Non-Human Primate model. In addition, we will assess and confirm the clearance of the L. jensenii 1153-1666 strain in the Non-Human primate following antibiotic administration.

该提案概述了一种新型活杀微生物剂MucoCept的开发，旨在预防女性通过异性性行为传播艾滋病毒。MucoCept是一种H2 O2- 产生阴道L. Jensenii 1153菌株，该菌株已被遗传修饰，组成性分泌一种有效的抗HIV蛋白，氰病毒蛋白-N（CV-N）。我们建议评估安全性、耐受性和对先天生殖道免疫因子的影响，在施用表达CV-N的L.詹塞尼命名为1153- 1666.第1666章非人类的动物此外，我们会评估及确认 L的间隙。jensenii 1153-1666菌株在非人灵长类动物中的抗生素管理。