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CMV Subunit Vaccine in Young Women at Risk

高危年轻女性的 CMV 亚单位疫苗

基本信息

批准号：
7807079
负责人：
Robert Floyd Pass
金额：
$ 4.62万
依托单位：
UNIVERSITY OF ALABAMA AT BIRMINGHAM
依托单位国家：
美国
项目类别：
财政年份：
2009
资助国家：
美国
起止时间：
2009-04-20 至 2012-07-31
项目状态：
已结题

来源：
https://reporter.nih.gov/project-details/7807079
关键词：
Adjuvant Adverse event Affect Antibodies Biological Assay Birth Blood CMV glycoprotein B Clinical Clinical Trials Controlled Clinical Trials Cytomegalovirus Cytomegalovirus Infections Cytomegalovirus Vaccines DNA Detection Dose Double-Blind Method Enrollment Event Hospitals Immunization Immunologics Infant Infection Learning Live Birth MF59 Methods Natural History Participant Phase Placebo Control Placebos Population Study Pregnancy Prevention Randomized Reaction Recruitment Activity Risk Safety Saliva Sampling Schedule Site Spontaneous abortion Subunit Vaccines Swab Testing Urine Vaccine Clinical Trial Vaccines Vagina Virus Virus Shedding Visit Woman base cell mediated immune response chiron vaccine congenital cytomegalovirus efficacy testing follow-up immunogenicity neutralizing antibody novel novel strategies offspring prevent response virus culture ward

项目摘要

DESCRIPTION (provided by applicant): This clinical trial will test the efficacy of cytomegalovirus (CMV) glycoprotein B (gB) vaccine (Aventis Pasteur) with MF59 adjuvant (Chiron Vaccines) to prevent maternal CMV infection, using a phase II, randomized, placebo controlled, double-blind clinical trial. Healthy young women are screened for antibody to CMV on the post-partum wards of 4 hospitals. Those who are seronegative are invited to participate in the clinical trial. Participants are enrolled and immunized (3 doses of vaccine, 0, 1 and 6 month schedule). Participants have follow-up visits every three months for three years after the third dose of vaccine in order to screen them for CMV infection, collect samples for immunogenicity studies, identify pregnancies and births, and collect safety information. All infants born to clinical trial participants are tested for congenital CMV infection by virus culture at birth. As of August 31, 2003, over 12,000 women had been screened for antibody to CMV, and 252 subjects enrolled. Twenty-eight CMV infections have occurred so far, a rate of 6.6% per year. There were 78 pregnancies among 66 trial participants, and 2 congenital CMV infections among 54 live births (3.7%). Important accomplishments in this trial to date include: enrolled around two-thirds of planned sample, developed a novel, accurate and inexpensive means of endpoint (CMV infection) detection for CMV vaccine clinical trials, recruited a study population with a CMV infection rate that allows us to accumulate the largest group of healthy asymptomatic young women with primary CMV infection ever studied, established use of immunologic and virologic assays that will allow us to learn a great deal from this trial whether or not vaccine is effective in preventing maternal infections. Specific aims will test the ability of CMV gB/MF59 vaccine to prevent maternal infection, evaluate the rate of congenital CMV infection in offspring of trial participants, determine whether maternal CMV infection is associated with miscarriage, characterize the virologic and immunologic features of primary CMV infections, evaluate novel approaches to end-point identification in CMV vaccine clinical trials, define long-term immunogenicity of study vaccine (antibody to CMV gB, neutralizing antibody and cell mediated immune response) and compare rates of adverse events as well as local and systemic reactions in CMV gB/MF59 recipients to placebo recipients. Based on enrollment to date and the rate of CMV infection in trial participants, we expect to have 60 to 90 CMV infections in the study population and approximately 200 pregnancies. With planned enrollment and these event rates, the clinical trial will achieve the power needed to test efficacy for prevention of maternal infection and will provide a preliminary estimate of whether immunization affects rates of congenital CMV infection.

描述(申请人提供)：这项临床试验将测试巨细胞病毒(CMV)糖蛋白B(GB)疫苗(安万特·巴斯德)与MF59佐剂(ChIron疫苗)预防母亲CMV感染的有效性，使用II期随机、安慰剂对照、双盲临床试验。在4家医院产后病房对健康青年妇女进行了CMV抗体筛查。那些血清阴性的人被邀请参加临床试验。参与者被登记并接种(3剂疫苗，0、1和6个月时间表)。参与者在第三剂疫苗接种后每三个月进行一次为期三年的跟踪访问，以筛查他们是否感染CMV，收集样本进行免疫原性研究，确定怀孕和出生情况，并收集安全信息。所有临床试验参与者出生的婴儿在出生时都会通过病毒培养进行先天性巨细胞病毒感染测试。截至2003年8月31日，已对12000多名妇女进行了CMV抗体筛查，有252名受试者参加了筛查。到目前为止，已发生28例CMV感染，年感染率为6.6%。66名受试者中有78人怀孕，54名活产婴儿中有2名先天性巨细胞病毒感染(3.7%)。到目前为止，这项试验的重要成就包括：招募了约三分之二的计划样本，为CMV疫苗临床试验开发了一种新颖、准确和廉价的终点(CMV感染)检测方法，招募了一组具有CMV感染率的研究人群，这使我们能够积累已研究过的最大规模的健康的无症状的原发CMV感染的年轻女性群体，建立了免疫学和病毒学分析的使用，这将使我们从这项试验中了解到疫苗在预防母体感染方面是否有效。具体目的将测试CMV GB/MF59疫苗预防母体感染的能力，评估试验参与者后代中先天性CMV感染率，确定母体CMV感染是否与流产有关，表征原发CMV感染的病毒学和免疫学特征，评估CMV疫苗临床试验中终点识别的新方法，确定研究疫苗(CMV GB抗体、中和抗体和细胞介导的免疫反应)的长期免疫原性，并比较接受CMV GB/MF59疫苗的人与安慰剂接受者的不良事件以及局部和全身反应。根据到目前为止的登记人数和试验参与者的CMV感染率，我们预计研究人群中将有60到90人感染CMV，大约200名孕妇。有了计划的登记和这些事件发生率，临床试验将达到测试预防母亲感染有效性所需的能力，并将提供关于免疫是否影响先天性CMV感染率的初步估计。