Macaca fascicularis vs. Macaca nemestrina as a model for topical microbicide safety studies.

Preclinical studies of topical microbicide products, using appropriate animal models for assessing the safety of repeated use are essential. The pig-tailed macaque (Macaca nemestrina) model has been used to assess the safety of vaginally and rectally applied topical microbicide products. The availability of sexually mature female pig-tailed macaques has become extremely restricted. Currently, M. fascicularis is more readily available, and was therefore evaluated as an alternative model for topical microbicide pre-clinical evaluation. Twenty sexually mature M. fascicularis were assessed for feasibility to mimic the established models. The rectal and cervicovaginal microenvironments of the M. fascicularis were determined to be similar to those of M. nemestrina and humans. The gross anatomy was significantly smaller than that of the pig-tailed macaque, such that colposcopic examinations and multiple biopsies would not be possible. Thus, the M. fascicularis may not be useful for vaginally applied topical microbicide safety studies yet adequate for assessing safety of rectally applied topical microbicide products.