RECOMBINANT CMV GB VACCINE IN POST-PARTUM WOMEN

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。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。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。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。

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. 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. The primary end-point is maternal CMV infection. Congenital infection in offspring is the main secondary endpoint.