Partnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia.
Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.
Trials. 2021 Jan 23;22(1):86. doi: 10.1186/s13063-021-05035-9.
The Ebola virus disease (EVD) outbreak in 2014-2016 in West Africa was the largest on record and provided an opportunity for large clinical trials and accelerated efforts to develop an effective and safe preventative vaccine. Multiple questions regarding the safety, immunogenicity, and efficacy of EVD vaccines remain unanswered. To address these gaps in the evidence base, the Partnership for Research on Ebola Vaccines (PREVAC) trial was designed. This paper describes the design, methods, and baseline results of the PREVAC trial and discusses challenges that led to different protocol amendments.
This is a randomized, double-blind, placebo-controlled phase 2 clinical trial of three vaccine strategies against the Ebola virus in healthy volunteers 1 year of age and above. The three vaccine strategies being studied are the rVSVΔG-ZEBOV-GP vaccine, with and without a booster dose at 56 days, and the Ad26.ZEBOV,MVA-FN-Filo vaccine regimen with Ad26.ZEBOV given as the first dose and the MVA-FN-Filo vaccination given 56 days later. There have been 4 versions of the protocol with those enrolled in Version 4.0 comprising the primary analysis cohort. The primary endpoint is based on the antibody titer against the Ebola virus surface glycoprotein measured 12 months following the final injection.
From April 2017 to December 2018, a total of 5002 volunteers were screened and 4789 enrolled. Participants were enrolled at 6 sites in four countries (Guinea, Liberia, Sierra Leone, and Mali). Of the 4789 participants, 2560 (53%) were adults and 2229 (47%) were children. Those < 18 years of age included 549 (12%) aged 1 to 4 years, 750 (16%) 5 to 11 years, and 930 (19%) aged 12-17 years. At baseline, the median (25th, 75th percentile) antibody titer to Ebola virus glycoprotein for 1090 participants was 72 (50, 116) EU/mL.
The PREVAC trial is evaluating-placebo-controlled-two promising Ebola candidate vaccines in advanced stages of development. The results will address unanswered questions related to short- and long-term safety and immunogenicity for three vaccine strategies in adults and children.
ClinicalTrials.gov NCT02876328 . Registered on 23 August 2016.
2014-2016 年西非的埃博拉病毒病（EVD）疫情是有记录以来最大的一次，为开展大型临床试验和加速开发有效和安全的预防疫苗提供了机会。关于 EVD 疫苗的安全性、免疫原性和疗效仍有许多问题尚未得到解答。为了解决这一证据基础上的空白，合作伙伴关系研究埃博拉疫苗（PREVAC）试验应运而生。本文描述了 PREVAC 试验的设计、方法和基线结果，并讨论了导致不同方案修正案的挑战。
这是一项针对健康志愿者（年龄在 1 岁及以上）的针对埃博拉病毒的三种疫苗策略的随机、双盲、安慰剂对照的 2 期临床试验。正在研究的三种疫苗策略是 rVSVΔG-ZEBOV-GP 疫苗，有和没有 56 天的加强剂量，以及 Ad26.ZEBOV，MVA-FN-Filo 疫苗方案，Ad26.ZEBOV 作为第一剂，MVA-FN-Filo 疫苗在 56 天后接种。该方案已经有 4 个版本，其中第 4.0 版本的入组者构成了主要分析队列。主要终点是根据最后一次注射后 12 个月测量的针对埃博拉病毒表面糖蛋白的抗体滴度来确定的。
从 2017 年 4 月至 2018 年 12 月，共有 5002 名志愿者接受了筛选，其中 4789 名被纳入。参与者在四个国家（几内亚、利比里亚、塞拉利昂和马里）的 6 个地点入组。在 4789 名参与者中，2560 名（53%）为成年人，2229 名（47%）为儿童。<18 岁的参与者包括 549 名（12%）1 至 4 岁，750 名（16%）5 至 11 岁，以及 930 名（19%）12-17 岁。在基线时，1090 名参与者的埃博拉病毒糖蛋白抗体中位数（25%，75%）为 72（50，116）EU/mL。
PREVAC 试验正在评估两种处于开发后期的有前途的埃博拉候选疫苗的安慰剂对照。结果将解决与三种疫苗策略在成人和儿童中的短期和长期安全性和免疫原性相关的未解答问题。
ClinicalTrials.gov NCT02876328。于 2016 年 8 月 23 日注册。
