This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.The Sexually Transmitted Disease PreventionPrimate Unit (STDP-PU) contract has been established as a means to comparatively assess topical microbicide products vis- -vis safety to cervical/vaginal tissues after repeated use, and efficacy in preventing cervical chlamydial infection. The contract is designed to assess first, effects that a formulated microbicide product has on the surface tissues and microenvironment of the cervix and vagina (modified colposcopy, cervical gram stain, pH, vaginal flora), thirty minutes and 24 hours after each application when applied daily for four days. This experiment tests for tissue and flora recovery within one week following final application. After a product has been shown not to induce deleterious outcome after repeated use, it will be assessed for its ability to prevent chlamydial infection of the cervix. In this experiment, a single dose of the formulated microbicide product is applied to each of six animals, followed (at thirty minutes) by a cervical challenge with Chlamydia trachomatis. Detection of viable chlamydial organisms and DNA, as well as serum antibody to chlamydia will be attempted for seven weeks post inoculation. This contract has been expanded to include the potential for conducting efficacy studies assessing prevention of Trichomonas vaginalis infection as well as chlamydia studies.
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