HERPEVAC TRIAL FOR WOMEN: A PHASE III VACCINE STUDY TO PREVENT GENITAL HERPES IN

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This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. Genital herpes is common in the U.S. affecting over 22% of all sexually active adults. The infection is incurable and places individuals at risk for substantial physical and mental health morbidity, as well as places infants born to infected mothers at risk for acquisition of congenital infections. Recent preliminary studies suggest that a glycoprotein vaccine developed by GlaxoSmithKline (GSK) reduces susceptibility to genital herpes in females who have not had prior infections due to Herpes simplex virus (HSV) type 1 or 2. We propose to conduct a NIH-sponsored Phase III controlled trial of a prototype HSV vaccine for prevention of genital herpes in females 18-30 years of age who are seronegative for antibodies and, if seronegative will be eligible for enrollment. Participants will receive 3 injections of the prototype vaccine, or for comparison, hepatitis A vaccine at months 0, 1, and 6 and be followed for serologic or microbiologic evidence of infection over a period of 20 months. At the UAB site we anticipate the need to screen over 3000 candidates in order to enroll 500 participants for vaccination and follow-up.