Safety and Efficacy Evaluations for Vaginal and Rectal Use of BufferGel in the Macaque Model

Abstract

In Brief Background: The nonhuman primate model allows for safety and efficacy testing of topical microbicide products. Goal: The goal of this study was to evaluate the safety and efficacy of vaginal and rectal applications of BufferGel (ReProtect, Inc.). Study Design: The safety of repeated product applications was evaluated by microflora, pH, vaginal colposcopy, and rectal lavage. To test efficacy in preventing chlamydia, infection was documented by culture and nucleic acid amplification tests. Results: Repeated vaginal or rectal applications of BufferGel were not associated with significant changes in microflora. BufferGel use had a transient acidifying effect on vaginal and rectal pH. Colposcopic observations remained relatively normal in all test animals. A slightly increased incidence of epithelial desquamation was noted after rectal product use compared with the control group. BufferGel did not prevent cervical or rectal chlamydial infection. Conclusion: BufferGel has an acceptable safety profile after repeated vaginal and rectal use, but does not prevent chlamydial infection in the macaque models. Repeated vaginal and rectal applications of BufferGel were found to be safe in the macaque model. However, BufferGel did not reliably prevent vaginal or rectal C. trachomatis infection in this model.