A DOUBLE-BLIND, RANDOMIZED, CONTROLLED PHASE III STUDY TO ASSESS THE PROPHYLACT

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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. The purpose of this multicenter, Phase III study is to evaluate the efficacy of a herpes vaccine (manufactured by GlaxoSmithKline Biologicals) in the prevention of genital herpes. This vaccine has been evaluated in 2 prior Phase III efficacy trials where the vaccine was found to be generally safe and effective in preventing genital herpes in women who had no prior history of herpes types 1 or 2 (HSV-1 or HSV-2). For this study, healthy women 18 to 30 years of age will be recruited from the community and from local college campuses. The UCLA CVR will oversee enrollment of 400 women: 150 at Harbor-UCLA, 150 at CSULB and 100 at CSUDH. At the screening visit, women will be tested for HSV by Western Blot, and may be eligible for enrollment if they are negative for HSV-1 and HSV-2, and if they are available for follow-up for a 20 month period. Study participants will be randomly assigned to receive 3 doses of the gD-Alum/MPL herpes vaccine or 3 doses of the hepatitis A (Havrix) vaccine at 0, 1 month and 6 months. At each study visit, they will be counseled about safe sex and means for preventing herpes. Blood samples will be obtained at 0, 2, 6, 7, 12, 16 and 20 months and tested for herpes. In addition, blood for cell mediated immunity (CMI) will be obtained at 2 and 7 months. Study participants who develop signs and/or symptoms of herpes during the 20 month follow-up period will be evaluated and a culture obtained. Participants who are found to be positive for herpes through serology or culture will be asked to take part in a herpes viral shedding sub-study. At the conclusion of the study, if the herpes vaccine is found to be effective, it will be offered to study participants who receive the hepatitis A vaccine.