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02343_2 CELLULOSE SULFATE SAFETY AND EFFICACY STUDIES IN THE MACAQUE MODEL Patton, Dorothy Cellulose Sulfate (CS) is a high molecular weight polymer being developed as a microbicide and for contraception efficacy. In these studies, CS was tested under a NIH contract for topical microbicide safety and efficacy testing in a macaque model. Safety evaluation included colposcopic, microbiologic, pH and histologic assessments, after each of four daily product applications. CS was shown to have an acceptable safety profile in these studies. No adverse findings were noted after multiple applications, by any parameter tested. A preclinical efficacy study was conducted to evaluate the products ability to prevent Chlamydia trachomatis (CT) infection. In this study, a single intravaginal application of the topical microbicide is followed (30 minutes) by cervical challenge with CT inoculant. Five of six animals that received CS application 30 minutes prior to chlamydial inoculation tested positive for cervical chlamydial infection during follow up. Three developed circulating IgG antibody against Chlamydia trachomatis. One additional animal had evidence of chlamydial antigen detected in biopsy tissues. All six control animals tested positive for cervical chlamydial infection, two of which developed a short-lived infection. Three control animals developed circulating IgG antibody, two of which also had chlamydial antigen detected in biopsy tissues. The CS was kindly provided by CONRAD. This work supported by NIH contract N01-AI-95388 and U of WA National Primate Research Center RR-00166. Dr. Dorothy Patton |
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