RECOMBINANT CMV GB VACCINE IN POST-PARTUM WOMEN

用于产后妇女的重组 CMV GB 疫苗

• 批准号: 7380398
• 负责人: Robert Floyd Pass
• 金额: $ 17.16万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-03-01 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380398
• 关键词: RECOMBINANT; CMV; GB; VACCINE; POST

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.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。这项 NIAID 支持的疫苗临床试验将检验以下假设：使用重组巨细胞病毒 (CMV) 包膜糖蛋白 (gB) 和新型专有佐剂 (MF59) 进行免疫接种可保护年轻女性免受 CMV 感染。所有研究疫苗研究访问都将在 GCRC 的门诊空间进行，利用 GCRC 临床空间和护理人员。此外，GCRC 将通过 UAB 外展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、安慰剂对照临床试验。参与者按 0、1 和 6 个月的时间表接受 CMVgB/MF59 疫苗或安慰剂（1:1 随机化），并每三个月跟踪一次 CMV 感染情况，持续 3 年半。研究参与者所生的所有婴儿都会接受先天性巨细胞病毒感染检测。主要终点是母体 CMV 感染。后代先天性感染是主要的次要终点。