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

这个子项目是许多研究子项目中利用 资源由NIH/NCRR资助的中心拨款提供。子项目和 调查员(PI)可能从NIH的另一个来源获得了主要资金， 并因此可以在其他清晰的条目中表示。列出的机构是 该中心不一定是调查人员的机构。 这项多中心第三阶段研究的目的是评估疱疹疫苗(由葛兰素史克生物制药公司生产)在预防生殖器疱疹方面的效果。该疫苗已经在之前的两次第三阶段疗效试验中进行了评估，在这些试验中，该疫苗被发现在预防既往没有1型或2型疱疹(HSV-1或HSV-2)病史的妇女中总体上是安全有效的。在这项研究中，18至30岁的健康女性将从社区和当地大学校园招募。 在筛查访问中，妇女将通过Western Blot进行HSV检测，如果HSV-1和HSV-2呈阴性，并且可以进行为期20个月的随访，则有资格参加登记。研究参与者将被随机分配在0、1个月和6个月时接种3剂GD-Alum/MPL疱疹疫苗或3剂甲型肝炎(Havrix)疫苗。 在20个月的随访期内出现疱疹体征和/或症状的研究参与者将接受评估并获得培养结果。通过血清学或培养发现疱疹阳性的参与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.