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

该子项目是利用 由NIH/NCRR资助的中心赠款提供的资源。子项目和 研究者（PI）可能从另一个NIH来源获得主要资金， 因此可以在其他CRISP条目中表示。列出的机构是 中心，不一定是研究者的机构。 这项多中心III期研究的目的是评价疱疹疫苗（由GlaxoSmithKline Biologicals生产）预防生殖器疱疹的有效性。该疫苗已在之前的2项III期疗效试验中进行了评价，其中发现该疫苗在预防无1型或2型疱疹（HSV-1或HSV-2）既往史的女性生殖器疱疹方面通常安全有效。在这项研究中，将从社区和当地大学校园招募18至30岁的健康女性。 在筛选访视时，将通过蛋白质印迹法对女性进行HSV检测，如果她们对HSV-1和HSV-2呈阴性，并且如果她们可接受20个月的随访，则可能有资格入组。研究受试者将被随机分配在0、1个月和6个月时接受3剂gD-Alum/MPL疱疹疫苗或3剂甲型肝炎（Havrix）疫苗。 将对在20个月随访期间出现疱疹体征和/或症状的研究受试者进行评价，并进行培养。通过血清学或培养发现疱疹阳性的受试者将被要求参加疱疹病毒脱落子研究。在研究结束时，如果发现疱疹疫苗有效，将提供给接受甲型肝炎疫苗的研究参与者。

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. 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. 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.