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02611_1 THE DEVELOPMENT OF A CYNOMOLOGOUS MACAQUE MODEL TO EVALUATE CANDIDATE VAGINAL MICROBICIDES Kish-Catalone, Tina* The cynomologous macaque primate model is a useful animal model for assessing the safety and efficacy of candidate vaginal microbicides. A comprehensive toxicity examination following compound application is currently in progress using the candidate microbicide -2 RANTES. The impact of microbicide exposure to the cervicovaginal mucosa was determined by colposcopic evaluations for evidence of gross tissue irritation and by examination of cervicovaginal biopsies for disruption and inflammation of the mucosal epithelium. Cervicovaginal lavage fluid was collected to determine pH changes, fluctuations in chemokine expression profiles and quantitation of specific immune cells types following microbicide treatment. Cervicovaginal swabs were collected for cytology studies and to assess changes within the vaginal microflora following compound exposure. In addition, formulation design can be optimized in this model with respect to variables such as distribution and absorption. Vaginal challenge studies in cynomologous macaques are essential to determine the efficacy of candidate microbicides in the prevention of viral transmission. Studies examining the efficacy of 2 RANTES in preventing infection by SHIV-BaL are currently in progress. Overall, the cynomologous macaque primate model provides critical safety and efficacy data to evaluate candidate vaginal microbicides. Tina Kish-Catalone, Ph.D. |
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