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

本子项目是利用由NIH/NCRR资助的中心赠款提供的资源的众多研究子项目之一。子项目和研究者（PI）可能已经从另一个NIH来源获得了主要资金，因此可以在其他CRISP条目中表示。列出的机构是中心的，不一定是研究者的机构。这项多中心III期研究的目的是评估一种疱疹疫苗（由葛兰素史克生物制品公司生产）在预防生殖器疱疹方面的功效。该疫苗已在之前的2项III期疗效试验中进行了评估，发现该疫苗在预防没有1型或2型疱疹（1型单纯疱疹病毒或2型单纯疱疹病毒）病史的妇女生殖器疱疹方面总体上是安全有效的。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。加州大学洛杉矶分校CVR将监督400名女性的入学情况：港湾-加州大学洛杉矶分校150名，加州大学洛杉矶分校150名，加州大学洛杉矶分校100名。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，则可能有资格参加。研究参与者将被随机分配在0、1和6个月时接受3剂gd -明矾/MPL疱疹疫苗或3剂甲型肝炎（Havrix）疫苗。在每次研究访问中，他们将被告知安全性行为和预防疱疹的方法。将在0、2、6、7、12、16和20个月时采集血液样本并检测疱疹。此外，将在2和7个月时获得细胞介导免疫（CMI）血。在20个月的随访期间出现疱疹体征和/或症状的研究参与者将被评估并进行培养。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，如果疱疹疫苗被发现是有效的，它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 teh 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.