RECOMBINANT CMV GB VACCINE IN POST-PARTUM WOMEN

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。 这项由NIAID支持的疫苗临床试验将检验这样一种假设，即用重组巨细胞病毒(CMV)包膜糖蛋白(GB)和新型专利佐剂(MF59)免疫将保护年轻女性免受CMV感染。在获得知情同意后，当地医院产后病房的年轻女性会接受CMV抗体筛查。那些血清阴性的人被邀请参加疫苗试验。符合登记标准的血清阴性志愿者在产后6周至12个月之间登记。所有研究疫苗研究访问将在GCRC的门诊空间进行，利用GCRC的诊所空间和护理人员。此外，GCRC将通过UAB外联实验室为临床试验参与者提供安全实验室测试。这是一项双盲、随机、安慰剂对照的临床试验。参与者按0、1和6个月的时间表接种CMVgB/MF59疫苗或安慰剂(1：1随机)，并每三个月跟踪一次CMV感染，为期三年半。研究参与者出生的任何婴儿都会接受先天性巨细胞病毒感染测试。研究结果至少每年由DSMB审查一次，以确定安全性和终点。主要终点是母体CMV感染。子代中的先天性感染是主要的次要终点。除了测试疫苗效力外，这项临床试验还将为研究原发CMV感染的病毒学、免疫学和临床特征提供前所未有的机会，因为临床试验参与者预计将有大量病例(60至90例)。最初的目标登记人数为400人，但总数将增加，以取代未接种所有三项研究疫苗或在登记时被发现血清阳性(筛查和第一项研究疫苗之间的血清转换)的受试者。

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. This NIAID supported vaccine clinical trial will test the hypothesis that immunization with a recombinant cytomegalovirus (CMV) envelope glycoprotein (gB) with a novel, proprietary adjuvant (MF59) will protect young women from CMV infection. After obtaining informed consent, young women on postpartum wards of local hospitals are screened for antibody to CMV. Those who are seronegative are invited to participate in the vaccine trial. Seronegative volunteers who meet enrollment criteria are enrolled between 6 weeks and 12 months postpartum. All study vaccine study visits will be conducted in the outpatient clinic space of the GCRC, utilizing GCRC clinical space and nursing personnel. In addition, the GCRC will provide safety laboratory testing in clinical trial participants through UAB Outreach Laboratory. This is a double-blind, randomized, placebo-controlled clinical trial. Participants receive CMVgB/MF59 vaccine or placebo (1:1 randomization) on a 0, 1, and 6 month schedule and are followed for CMV infection every three months for 3 and one-half years. Any babies born to study participants are tested for congenital CMV infection. Study results are reviewed for safety and endpoints by a DSMB at least annually. The primary end-point is maternal CMV infection. Congenital infection in offspring is the main secondary endpoint. In addition to testing vaccine efficacy, this clinical trial will offer an unprecedented opportunity for virologic, immunologic and clinical characterization of primary CMV infection as a large number of cases (60 to 90) are expected in clinical trial participants. Initial target enrollment was 400 subjects, but the total will be increased to replace subjects who did not receive all three study vaccines or were found to be seropositive at enrollment (seroconverted between screening and 1st study vaccine).