Characterisation of novel microbicide safety biomarkers in East and South Africa

Objective

The overall goal is to identify promising biomarkers that could be introduced in the next generation of microbicide safety trials, and baseline data on these biomarkers against which future assessments in women who are using candidate microbicide products can be compared.

Background

Vaginal microbicides are being developed to expand HIV prevention options for women and couples. A healthy vaginal environment protects women from infections and should therefore remain intact during and after product administration. Up to recently, microbicide safety trials included naked-eye pelvic exams and colposcopy to visualise genital epithelial disruption and inflammation and vaginal fluid microscopy to evaluate the vaginal flora. However, recent experiences with the candidate microbicide cellulose sulfate gel suggest that these measurements are insufficient to predict harm. Since then, some research groups have started to include biomarkers of genital inflammation and epithelial integrity, and have started to enumerate HIV target cells, in human safety trials. However, normative value ranges of these biomarkers have not yet been established in population groups that are relevant for microbicide trials, and many additional potential biomarkers have not yet been evaluated. The project will sample a variety of study populations in four African settings to try and refine both clinical and laboratory methods and findings in search of more reliable safety biomarkers. The consortium offers the combination of multidisciplinary experience and cutting-edge technology to make this possible.

Summary