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

这个子项目是利用由NIH/NCRR资助的中心拨款提供的资源的许多研究子项目之一。子项目和调查员(PI)可能从另一个NIH来源获得了主要资金，因此可能会出现在其他CRISE条目中。列出的机构是针对中心的，而不一定是针对调查员的机构。生殖器疱疹在美国很常见，超过22%的性行为活跃的成年人受到影响。这种感染是无法治愈的，使个人面临患上严重身心健康疾病的风险，并使受感染母亲所生的婴儿有患先天性感染的风险。最近的初步研究表明，葛兰素史克(GSK)开发的一种糖蛋白疫苗可以降低以前没有感染过1型或2型单纯疱疹病毒(HSV)的女性对生殖器疱疹的易感性。我们建议进行一项由NIH赞助的原型HSV疫苗的第三阶段对照试验，用于预防抗体血清阴性的18-30岁女性生殖器疱疹，如果血清阴性，将有资格参加登记。参与者将在0个月、1个月和6个月接受3次甲型肝炎疫苗注射，并在20个月的时间内接受血清学或微生物学感染证据的跟踪。在UAB网站，我们预计需要筛选3000多名候选人，以便招募500名参与者进行疫苗接种和后续工作。

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.