Characterisation of novel microbicide safety biomarkers in East and South Africa


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.


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.


Name: Biomarkers: Characterisation of novel microbicide safety biomarkers in East and South Africa
Status: Closed
Principal Investigator: Dr. J.H.H.M. van de Wijgert
Partners: -International Centre for Reproductive Health Kenya (ICRH-K)

-Projet Ubuzima

-Microbicide Trials Unit at the National Institute for Medical Research (MITU/NIMR)

-Prince Leopold Institute for Tropical Medicine (ITM)

-Ghent University

-London School for Hygiene and Tropical Medicine (LSHTM)

Contact information: Project manager: Friso Janssen


Duration: Start date: 6 April 2009

Duration: 36 months

End date: 6 April 2012

Funded by: EDCTP
Countries: South Africa