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Development of a rapid point of care diagnostic,to monitor MucoCept-CVN, an HIV-targeted biotherapy,

开发快速护理诊断，以监测 MucoCept-CVN（一种针对 HIV 的生物疗法）

基本信息

批准号：
9137087
负责人：
Laurel A. Lagenaur
金额：
$ 22.5万
依托单位：
OSEL, INC.
依托单位国家：
美国
项目类别：
财政年份：
2016
资助国家：
美国
起止时间：
2016-04-01 至 2018-03-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/9137087
关键词：
Antiviral Agents Bacteria Biological Biological Response Modifier Therapy Buffers Cell Count Clinical Clinical Trials Cyanovirin-N Data Detection Development Devices Diagnostic Diagnostic tests Effectiveness Evaluation Female Future Genes Goals Grant HIV HIV Envelope Protein gp120 HIV-1 Human Immunoassay In Vitro Infection Intravaginal Administration Irrigation Lactobacillus Life Macaca Macaca mulatta Modeling Monitor Monoclonal Antibodies Mucous Membrane Phase Prevention strategy Proteins Recombinants Research Design Sampling Site Small Business Innovation Research Grant Swab Tablets Technology Testing User Compliance Vagina Validation Woman base cervicovaginal in vivo inhibitor/antagonist microbicide microbiome microbiota phase 1 study phase 2 study point of care point-of-care diagnostics prototype public health relevance rapid technique simian human immunodeficiency virus success transmission process vaginal fluid vaginal lactobacilli vaginal microbiome

项目摘要

DESCRIPTION (provided by applicant: The overall goal of this project is to develop a live biotherapeutic product (LBP), MucoCept-mCVN, to protect women from HIV-1 infection by enhancing the antiviral activity of the vaginal microbiome. MucoCept- mCVN contains a recombinant vaginal strain of Lactobacillus jensenii that colonizes the vaginal mucosa and produces a potent HIV-1-neutralizing protein, modified CV-V (mCV-N). Once incorporated into the vaginal microbiota, the recombinant L. jensenii strain replicates and constitutively produces mCV-N in the vaginal mucosa, the primary site of HIV-1 infection in women. Since the bacteria can persist in the vagina, MucoCept- mCVN protects against HIV-1 transmission in a coitally independent manner. The feasibility of this product concept has been established in a number of studies. A genetically stable recombinant L. jensenii, strain 1153- 1666, was created that secretes biologically significant levels of a broadly neutralizing HIV-1 entry inhibitor protein, mCV-N. The L. jensenii 1153-1666 bacteria have been successfully formulated as a vaginally disintegrating tablet (VDT). Both freshly prepared cultures of L. jensenii 1153-1666 and the formulated bacteria in tablet form have been shown to vaginally colonize rhesus macaques, produce mCV-N in vivo, and protect macaques against SHIV infection in a repeated SHIV vaginal challenge model. The proposed SBIR Phase 1 studies are designed to develop a rapid and simple point of care (POC) diagnostic test for MucoCept-mCVN. Since the vaginal microbiota differs among women and can change overtime, this test will allow women to monitor protective levels of mCVN to maximize the effectiveness of the product.