CONRAD has been spearheading the effort to find a biomarker of semen exposure suitable for use in contraceptive and microbicide efficacy trials. In 2004, CONRAD and Ibis Reproductive Health sponsored a meeting funded in part by the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) and the National Institute of Allergy and Infectious Diseases (NIAID), entitled “Evaluation of Markers of Intercourse in Trials of Vaginal Barriers.” At the time of the meeting, there were major gaps in knowledge about these markers. Work begun at the meeting has been continued by regular teleconferences under the direction of CONRAD. Two studies are already underway as a result and a manuscript entitled, "Biomarkers of semen in the vagina: application in clinical trials of contraception and prevention of sexually transmitted pathogens including HIV" was published in the journal Contraception in June 2007.
CONRAD and the Alliance for Microbicide Development also sponsored a meeting in Reston, Virginia in November 2006 that reviewed the current status of biomarkers, not just of semen exposure but of inflammation and HIV exposure. The meeting served to assess how emerging technologies from other industries might be applied to the microbicide field, and to encourage innovation and collaboration among a broad spectrum of researchers within and beyond that field. Proceedings from the meetings have been published as a supplement in Sexually Transmitted Diseases 36:(3), March 2009.
In 2008, CONRAD convened a meeting of experts to devise a female condom study design that would validate a biomarker against a biological endpoint, such as pregnancy or a sexually transmitted infection (STI), to augment slippage and breakage studies for approval of new female condoms in the hope of eliminating the need for the currently required contraceptive effectiveness trial. Prostate-specific antigen (PSA) was agreed to be the best indicator of female condom performance, providing stronger evidence than pregnancy or STIs, given the extreme variability in fertility, timing of sex, partner infection, participant compliance, and self-reporting of compliance. Proceedings were published in the May 2009 issue of Contraception. An ongoing clinical study comparing the Woman's Condom and the FC2 Female Condom is using detection of vaginal PSA as an indicator of condom failure.
To learn more about CONRAD's preclinical and clinical biomarker activities, click here.