Reducing Vertical Transmission of Hepatitis B in Africa (REVERT-B Trial)

减少非洲乙型肝炎的垂直传播(REVERT-B 试验)

基本信息

  • 批准号:
    10612859
  • 负责人:
  • 金额:
    $ 39.66万
  • 依托单位:
  • 依托单位国家:
    美国
  • 项目类别:
  • 财政年份:
    2020
  • 资助国家:
    美国
  • 起止时间:
    2020-05-18 至 2025-03-31
  • 项目状态:
    未结题

项目摘要

Project Summary/Abstract Hepatitis B virus (HBV) infection is endemic among pregnant women in Africa yet most women are asymptomatic and unaware that their infants are at risk. Ninety percent of infants infected at birth will develop chronic HBV infection with late manifestations of disease that include cirrhosis and hepatocellular carcinoma. The World Health Organization set a goal of HBV elimination by 2030 but current perinatal prophylaxis in Africa is inadequate. This is a key barrier to reducing the population prevalence of disease. HBV vaccination from birth is 75-95% effective but low facility delivery rates and vaccine cold chain requirements hinder the success of this one-pronged approach. Most HBV-exposed infants in Africa receive their first HBV vaccine at 2-3 months of age which misses the perinatal prevention window. To address this pressing problem, this R01 application describes gaps in scientific knowledge needed to advance perinatal HBV prevention considering the potential efficacy of tenofovir therapy in reducing HBV viral load based on two published randomized trials in Asia and a potential role for neonatal lamivudine prophylaxis. The central goal of this proposal is to identify a novel intervention that is effective, safe and pragmatic in preventing perinatal transmission of HBV in Africa. This was developed in response to NICHD priorities cited in PA-18-031. To meet this goal, an innovative, multicenter clinical trial titled “REVERT-B: Reducing Vertical Transmission of Hepatitis B in Africa” was designed to be carried out by a collaborative, productive and experienced research team at the University of Alabama at Birmingham (UAB) and in Cameroon. It will test the hypothesis that maternal and neonatal antiviral prophylaxis significantly reduces HBV vertical transmission among high-risk women in Africa compared to optimized standard of care (4-dose HBV vaccination beginning at birth). The hypothesis will be efficiently tested by pursuing two co-primary aims with a factorial trial design. In Aim 1, a randomized, placebo-controlled trial will be conducted in four prenatal clinics in Cameroon to test the efficacy of tenofovir in 480 pregnant women with HBV in reducing perinatal transmission. Women will be randomized to daily tenofovir or placebo with a background of optimized standard of care (infant vaccination). In Aim 2, neonates will be randomized to oral lamivudine or placebo for six weeks to test the efficacy of neonatal prophylaxis. The primary endpoint for both aims is perinatal transmission defined as the proportion of infants with active HBV infection (HBsAg+) at 6 months of age. Sub-aims will assess the safety of prophylaxis and medication adherence. Data from this Phase III trial will be used to support follow up studies to test the effectiveness and feasibility of combination maternal and/or neonatal antiviral prophylaxis in a multi-country study of pregnant women in resource-limited settings. The expected outcome is to expand the scientific toolkit for pregnant women with HBV (analogous to perinatal HIV prevention) and advance toward the long-term goal of eliminating perinatal HBV transmission worldwide.
项目摘要/摘要 乙肝病毒感染在非洲孕妇中很流行,但大多数妇女都没有症状。 并且没有意识到他们的婴儿处于危险之中。90%在出生时感染的婴儿会发展为慢性乙肝病毒 晚期症状的感染,包括肝硬变和肝细胞癌。世界 卫生组织制定了到2030年消除乙肝病毒的目标,但目前非洲的围产期预防措施是 不够充分。这是降低人口疾病流行率的关键障碍。从出生起就接种乙肝疫苗 75%-95%的有效率但设施递送率低和疫苗冷链要求阻碍了这一项目的成功 单管齐下。非洲大多数感染了乙肝病毒的婴儿在2-3个月大的时候接种了第一次乙肝疫苗 这错过了围产期预防的窗口。为了解决这个紧迫的问题,此R01应用程序描述了 考虑到围产期乙肝病毒预防的潜在疗效,在科学知识方面的差距 基于亚洲两项已发表的随机试验和一项潜在研究的替诺福韦治疗降低乙肝病毒载量 拉米夫定对新生儿的预防作用。这项提议的中心目标是确定一种新的干预措施, 在非洲预防乙肝病毒围产期传播是有效、安全和务实的。这是在 对PA-18-031中引用的《消除种族歧视国际公约》的优先事项作出回应。为了实现这一目标,一项名为 “逆转-B:减少乙肝在非洲的垂直传播”是由一个 阿拉巴马大学伯明翰分校(UAB)合作、富有成效和经验丰富的研究团队 在喀麦隆。它将检验母亲和新生儿抗病毒预防显著减少的假设 非洲高危妇女中乙肝病毒垂直传播与优化护理标准(4剂)的比较 从出生开始接种乙肝疫苗)。通过追求两个共同的主要目标,这一假设将得到有效的检验 采用析因试验设计。在目标1中,将在四个产前进行随机、安慰剂对照试验 喀麦隆诊所测试替诺福韦对480名携带乙肝病毒的孕妇减少围产期的疗效 变速箱。妇女将随机服用每日替诺福韦或安慰剂,背景为优化的标准 护理(婴儿疫苗接种)。在目标2中,新生儿随机服用拉米夫定或安慰剂,为期六周。 目的:检验新生儿预防措施的效果。这两个目标的主要终点都是定义的围产期传播 6个月时活动性乙肝病毒感染(乙肝表面抗原阳性)婴儿的比例。次级目标将评估 预防和用药依从性的安全性。第三阶段试验的数据将用于支持后续行动 对孕妇和/或新生儿联合进行抗病毒预防的有效性和可行性的研究 一项对资源有限环境中的孕妇进行的多国研究。预期的结果是扩大 为携带乙肝病毒的孕妇提供科学工具包(类似于围产期艾滋病毒预防),并朝着 在全球范围内消除围产期乙肝病毒传播的长期目标。

项目成果

期刊论文数量(0)
专著数量(0)
科研奖励数量(0)
会议论文数量(0)
专利数量(0)

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

数据更新时间:{{ journalArticles.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ monograph.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ sciAawards.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ conferencePapers.updateTime }}

{{ item.title }}
  • 作者:
    {{ item.author }}

数据更新时间:{{ patent.updateTime }}

Jodie Ann Dionne其他文献

Jodie Ann Dionne的其他文献

{{ item.title }}
{{ item.translation_title }}
  • DOI:
    {{ item.doi }}
  • 发表时间:
    {{ item.publish_year }}
  • 期刊:
  • 影响因子:
    {{ item.factor }}
  • 作者:
    {{ item.authors }}
  • 通讯作者:
    {{ item.author }}

{{ truncateString('Jodie Ann Dionne', 18)}}的其他基金

Syphilis in Pregnancy Study (SIPS): Molecular Diagnostics and Maternal and Infant Immune Response to Infection
妊娠期梅毒研究 (SIPS):分子诊断以及母婴对感染的免疫反应
  • 批准号:
    10702053
  • 财政年份:
    2023
  • 资助金额:
    $ 39.66万
  • 项目类别:
Reducing Vertical Transmission of Hepatitis B in Africa (REVERT-B Trial)
减少非洲乙型肝炎的垂直传播(REVERT-B 试验)
  • 批准号:
    10166897
  • 财政年份:
    2020
  • 资助金额:
    $ 39.66万
  • 项目类别:
Reducing Vertical Transmission of Hepatitis B in Africa (REVERT-B Trial)
减少非洲乙型肝炎的垂直传播(REVERT-B 试验)
  • 批准号:
    10375537
  • 财政年份:
    2020
  • 资助金额:
    $ 39.66万
  • 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
  • 批准号:
    10219749
  • 财政年份:
    2019
  • 资助金额:
    $ 39.66万
  • 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
  • 批准号:
    10218997
  • 财政年份:
    2019
  • 资助金额:
    $ 39.66万
  • 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
  • 批准号:
    10371064
  • 财政年份:
    2019
  • 资助金额:
    $ 39.66万
  • 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
  • 批准号:
    10217939
  • 财政年份:
    2019
  • 资助金额:
    $ 39.66万
  • 项目类别:
UAB-MISS MACS/WIHS Combined Cohort Study
UAB-MISS MACS/WIHS 联合队列研究
  • 批准号:
    9903482
  • 财政年份:
    2019
  • 资助金额:
    $ 39.66万
  • 项目类别:
A Novel Regimen to Prevent Malaria and STIs in Pregnant Women with HIV
预防艾滋病毒孕妇疟疾和性传播感染的新疗法
  • 批准号:
    9766109
  • 财政年份:
    2016
  • 资助金额:
    $ 39.66万
  • 项目类别:
A Novel Regimen to Prevent Malaria and STIs in Pregnant Women with HIV
预防艾滋病毒孕妇疟疾和性传播感染的新疗法
  • 批准号:
    9270984
  • 财政年份:
    2016
  • 资助金额:
    $ 39.66万
  • 项目类别:

相似海外基金

Pharmacy-led Transitions of Care Intervention to Address System-Level Barriers and Improve Medication Adherence in Socioeconomically Disadvantaged Populations
药房主导的护理干预转型,以解决系统层面的障碍并提高社会经济弱势群体的药物依从性
  • 批准号:
    10594350
  • 财政年份:
    2023
  • 资助金额:
    $ 39.66万
  • 项目类别:
Evaluating Centralizing Interventions to Address Low Adherence to Lung Cancer Screening Follow-up in Decentralized Settings
评估集中干预措施,以解决分散环境中肺癌筛查随访依从性低的问题
  • 批准号:
    10738120
  • 财政年份:
    2023
  • 资助金额:
    $ 39.66万
  • 项目类别:
Suubi-Mhealth: A mobile health intervention to address depression and improve ART adherence among Youth living with HIV (YLHIV) in Uganda
Suubi-Mhealth:一种移动健康干预措施,旨在解决乌干达艾滋病毒感染者 (YLHIV) 青少年的抑郁症问题并提高抗逆转录病毒疗法的依从性
  • 批准号:
    10526768
  • 财政年份:
    2022
  • 资助金额:
    $ 39.66万
  • 项目类别:
Suubi-Mhealth: A mobile health intervention to address depression and improve ART adherence among Youth living with HIV (YLHIV) in Uganda
Suubi-Mhealth:一种移动健康干预措施,旨在解决乌干达艾滋病毒感染者 (YLHIV) 青少年的抑郁症问题并提高抗逆转录病毒疗法的依从性
  • 批准号:
    10701072
  • 财政年份:
    2022
  • 资助金额:
    $ 39.66万
  • 项目类别:
A behavioral intervention for Black men who have sex with men and live with HIV to address intersectional stigma and improve antiretroviral therapy adherence
针对男男性行为且感染艾滋病毒的黑人男性进行行为干预,以解决交叉耻辱并提高抗逆转录病毒治疗的依从性
  • 批准号:
    10679092
  • 财政年份:
    2021
  • 资助金额:
    $ 39.66万
  • 项目类别:
A behavioral intervention for Black men who have sex with men and live with HIV to address intersectional stigma and improve antiretroviral therapy adherence
针对男男性行为且感染艾滋病毒的黑人男性进行行为干预,以解决交叉耻辱并提高抗逆转录病毒治疗的依从性
  • 批准号:
    10432133
  • 财政年份:
    2021
  • 资助金额:
    $ 39.66万
  • 项目类别:
A behavioral intervention for Black men who have sex with men and live with HIV to address intersectional stigma and improve antiretroviral therapy adherence
针对男男性行为且感染艾滋病毒的黑人男性进行行为干预,以解决交叉耻辱并提高抗逆转录病毒治疗的依从性
  • 批准号:
    10327065
  • 财政年份:
    2021
  • 资助金额:
    $ 39.66万
  • 项目类别:
Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans with COPD
利用技术解决慢性阻塞性肺病退伍军人接受和坚持传统医院肺康复的问题
  • 批准号:
    10377366
  • 财政年份:
    2019
  • 资助金额:
    $ 39.66万
  • 项目类别:
Leveraging Technology to Address Access and Adherence to Conventional Hospital-Based Pulmonary Rehabilitation in Veterans with COPD
利用技术解决慢性阻塞性肺病退伍军人接受和坚持传统医院肺康复的问题
  • 批准号:
    10574496
  • 财政年份:
    2019
  • 资助金额:
    $ 39.66万
  • 项目类别:
Targeted interventions to address the multi-level effects of gender-based violence on PrEP uptake and adherence among adolescent girls and young women in Kenya
有针对性的干预措施,以解决性别暴力对肯尼亚少女和年轻妇女接受和坚持 PrEP 的多层面影响
  • 批准号:
    9403567
  • 财政年份:
    2017
  • 资助金额:
    $ 39.66万
  • 项目类别:
{{ showInfoDetail.title }}

作者:{{ showInfoDetail.author }}

知道了