RECOMBINANT CMV GB VACCINE IN POST-PARTUM WOMEN

用于产后妇女的重组 CMV GB 疫苗

• 批准号: 7603165
• 负责人: Robert Floyd Pass
• 金额: $ 18.49万
• 依托单位: UNIVERSITY OF ALABAMA AT BIRMINGHAM
• 依托单位国家: 美国
• 财政年份: 2007
• 资助国家: 美国
• 起止时间: 2007-03-01 至 2008-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7603165
• 关键词: Adjuvant; Ambulatory Care Facilities; Antibodies; Clinical; Clinical Trials; Computer Retrieval of Information on Scientific Projects Database; Controlled Clinical Trials; Cytomegalovirus; Cytomegalovirus Infections; Double-Blind Method; End Point; Enrollment; Funding; Glycoproteins; Grant; Hospitals; Immunization; Immunologics; Informed Consent; Institution; Laboratories; MF59; National Institute of Allergy and Infectious Disease; Numbers; Nursing Staff; Participant; Placebo Control; Placebos; Postpartum Period; Randomized; Recombinants; Research; Research Personnel; Resources; Safety; Schedule; Screening procedure; Source; Testing; United States National Institutes of Health; Vaccine Clinical Trial; Vaccines; Visit; Week; Woman; congenital cytomegalovirus; congenital infection; novel; outreach; vaccine efficacy; volunteer; ward

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).

该副本是利用众多研究子项目之一 由NIH/NCRR资助的中心赠款提供的资源。子弹和 调查员（PI）可能已经从其他NIH来源获得了主要资金， 因此可以在其他清晰的条目中代表。列出的机构是 对于中心，这不一定是调查员的机构。 这项支持疫苗临床试验的NIAID将检验以下假设：重组巨细胞病毒（CMV）包膜糖蛋白（GB）具有新型的，专有的辅助剂（MF59）将保护年轻女性免受CMV感染的侵害。 在获得知情同意书后，对当地医院产后病房的年轻妇女进行了筛查，以抗CMV的抗体。 邀请血清调子的人参加疫苗试验。 符合入学标准的血清志志愿者在产后6周至12个月之间。 所有研究疫苗研究访问都将在GCRC的门诊诊所空间进行，利用GCRC临床空间和护理人员进行。 此外，GCRC将通过UAB外展实验室在临床试验参与者中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。 参与者在0、1和6个月的时间表上接受CMVGB/MF59疫苗或安慰剂（1：1随机分组），并随后每三个月感染CMV感染，持续3年和一半。研究参与者出生的任何婴儿均可接受先天性CMV感染。 至少每年，DSMB对研究结果进行了安全和终点的审查。 主要终点是母体CMV感染。 后代的先天性感染是主要的次要终点。 除了测试疫苗功效外，这项临床试验还将为原发性CMV感染的病毒学，免疫和临床表征提供前所未有的机会，作为大量病例（60至90例）（60至90）。 初始目标入学率为400名受试者，但总数将增加，以替换未接受所有三种研究疫苗的受试者或在入学时被发现具有血清阳性的受试者（在筛查和第一研究疫苗之间进行血清转化）。