Rwanda Zambia Health Research Group, Center for Family Health Research/Projet San Francisco, Kigali, Rwanda.
Rwanda Zambia Health Research Group, Department of Pathology & Laboratory Medicine, School of Medicine, Emory University, Atlanta, GA, USA.
Trials. 2022 Jun 20;23(1):513. doi: 10.1186/s13063-022-06360-3.
Risks to mother and fetus following Ebola virus infection are very high. Evaluation of safety and immunogenicity of non-replicating Ebola vaccine candidates is a priority for use in pregnant women. This is the protocol for a randomized, open-label, single-center phase 3 clinical trial of the safety, reactogenicity, and immunogenicity of the 2-dose Ebola vaccine regimen in healthy adult pregnant women. This 2-dose regimen has been shown to be safe, judged effective, and approved in non-pregnant populations.
A total of 2000 adult (≥ 18 years of age) pregnant women will be enrolled from antenatal care facilities in Western Rwanda and randomized (1:1) to receive the 2-dose Ebola vaccine regimen (Ad26.ZEBOV, MVA-BN-Filo (group A)) or control (unvaccinated pregnant women (group B)). The primary objectives are to (1) assess adverse maternal/fetal outcomes in randomized pregnant women up to 1.5 months after delivery and (2) assess adverse neonatal/infant outcomes in neonates/infants born to randomized women up to 3.5 months after birth. The frequency and relatedness of all serious adverse events in women and newborns from randomization or birth, respectively, until study end will be reported. The reactogenicity and unsolicited adverse events of the 2-dose Ebola vaccine regimen in all vaccinated pregnant women (group A) will be reported. We will also assess the immunogenicity of the 2-dose Ebola vaccine regimen in 150 pregnant women who are anticipated to receive both vaccine doses within the course of their pregnancy (a subset of the 1000 pregnant vaccinated women from group A) compared to 150 non-pregnant women vaccinated after delivery (a subset of group B). The persistence of maternal antibodies in 75 infants born to women from the group A subset will be assessed. Exploratory analyses include assessment of acceptability of the 2-dose Ebola vaccine regimen among group A and assessment of maternal antibodies in breast milk in 50 women from group A and 10 controls (women from group B prior to vaccination).
This study is intended to support a label variation to relax restrictions on use in pregnant women, a vulnerable population with high medical need.
Clinicaltrials.gov NCT04556526 . September 21, 2020.
埃博拉病毒感染对母婴的风险非常高。评估非复制型埃博拉候选疫苗在孕妇中的安全性和免疫原性是优先事项。这是一项在卢旺达西部产前保健机构中健康成年孕妇中进行的 2 剂埃博拉疫苗方案安全性、反应原性和免疫原性的随机、开放标签、单中心 3 期临床试验方案。该 2 剂方案已被证明在非妊娠人群中是安全的、有效果的，并获得批准。
将从卢旺达西部的产前保健机构中招募 2000 名成年（≥18 岁）孕妇，将其随机（1:1）分为两组，分别接受 2 剂埃博拉疫苗方案（Ad26.ZEBOV、MVA-BN-Filo（A 组））或对照组（未接种疫苗的孕妇（B 组））。主要目的是（1）评估产后 1.5 个月内随机孕妇的母婴不良结局，（2）评估出生后 3.5 个月内随机孕妇所生新生儿/婴儿的不良新生儿/婴儿结局。将从随机化或出生起，分别报告所有接受疫苗接种的孕妇（A 组）和新生儿/婴儿（B 组）的所有严重不良事件的频率和相关性，直至研究结束。将报告所有接受 2 剂埃博拉疫苗方案的孕妇（A 组）的反应原性和不良反应。我们还将评估 150 名预期在妊娠期间接受 2 剂疫苗的孕妇（A 组的 1000 名孕妇中的一个亚组）和 150 名产后接种疫苗的非孕妇（B 组的一个亚组）的 2 剂埃博拉疫苗方案的免疫原性。将评估 A 组亚组中 75 名母亲所生婴儿的母体抗体持久性。探索性分析包括 A 组中 2 剂埃博拉疫苗方案的可接受性评估和 A 组中 50 名妇女和 10 名对照者（接种疫苗前 B 组的妇女）的母乳中的母体抗体评估。
本研究旨在支持放宽对孕妇使用的限制，为高危人群提供急需的医疗服务。
Clinicaltrials.gov NCT04556526。2020 年 9 月 21 日。
