The Topical Microbicide Safety and Efficacy Evaluation in Nonhuman Primates contract provides preclinical testing (safety and efficacy) of topical microbicides, with or without barrier devices, using nonhuman primate models. All test products, provided by NIAID, will first complete safety evaluation with repeated intravaginal product application. If an acceptable safety profile results from these studies, a product will progress (with NIAID approval) to efficacy studies involving one or more STI. Safety measures include microbiologic and pH assessments and documentation of mucosal tissue responses as evidenced by colposcopic evaluation. Efficacy will be determined by a product s ability to prevent infection by the challenge pathogen.
