Evidence map›Paper›PMID 33485369›Full record

ArticleTrials2021

Partnership for Research on Ebola VACcination (PREVAC): protocol of a randomized, double-blind, placebo-controlled phase 2 clinical trial evaluating three vaccine strategies against Ebola in healthy volunteers in four West African countries.

Moses Badio, Edouard Lhomme, Mark Kieh, Abdoul Habib Beavogui, Stephen B Kennedy, Seydou Doumbia, Bailah Leigh, Samba O Sow, Alpha Diallo, Daniela Fusco and 16 more

Erratum issued Registry-linked trialOpen access · goldAbstract readClinical Trial Protocol
In one paragraph

Article in Trials, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. It is linked to trial NCT02876328 (Partnership for Research on Ebola VACcinations), which is not on this map. Cited by 13 papers.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed
0.9field-weighted citation impact, top 23% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT02876328 phase2completednot on this map

Partnership for Research on Ebola VACcinations (PREVAC)

TypeinterventionalSponsorNational Institute of Allergy and Infectious Diseases (NIAID)Ran2017 to 2023Enrolled4,789ConditionsEbola Virus DiseaseArmsAd26.ZEBOV, MVA-BN-Filo, rVSVΔG-ZEBOV-GP, Placebo, rVSV boost
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 16 citations in OpenAlex.

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  5. Cross-reactive Bundibugyo antibody responses after licensed Ebola vaccines.medRxiv : the preprint server for health sciences · 2026
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4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

26 authors at 10 institutions in 6 countries.

Moses Badio *Partnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia.
Edouard Lhomme *Univ. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.ORCID http://orcid.org/0000-0003-0214-1694
Mark KiehPartnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia.
Abdoul Habib BeavoguiCentre National de Formation et de Recherche en Santé Rurale de Mafèrinyah, Mafèrinyah, Guinea.
Stephen B KennedyPartnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia.
Seydou DoumbiaUniversity of Sciences, Technique and Technology of Bamako, Bamako, Mali.
Bailah LeighCollege of Medicine and Allied Health Sciences (COMAHS), University of Sierra Leone, Freetown, Sierra Leone.
Samba O SowCentre pour le Développement des Vaccins, Bamako, Mali.
Alpha DialloINSERM, Pôle de Recherche Clinique, 75013, Paris, France.
Daniela FuscoINSERM, Pôle de Recherche Clinique, 75013, Paris, France.
Matthew KirchoffNational Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Monique TermoteUniv. Bordeaux, Inserm, Bordeaux Population Health Research Center, UMR 1219, CHU Bordeaux, CIC 1401, EUCLID/F-CRIN Clinical Trials Platform, F-33000, Bordeaux, France.
Renaud VatrinetREACTing, Institut Thématique Immunologie, Inflammation, Infectiologie et Microbiologie, Inserm, Paris, France.
Deborah WentworthDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Helène EsperouINSERM, Pôle de Recherche Clinique, 75013, Paris, France.
H Clifford LaneNational Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Jerome PiersonNational Institute of Allergy and Infectious Diseases, Bethesda, MD, USA.
Deborah Watson-JonesLondon School of Hygiene & Tropical Medicine, London, UK.
Céline RoyPartnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia.
Eric D'OrtenzioREACTing, Institut Thématique Immunologie, Inflammation, Infectiologie et Microbiologie, Inserm, Paris, France.
Brian GreenwoodLondon School of Hygiene & Tropical Medicine, London, UK.
Genevieve ChênePartnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia.
Laura RichertPartnership for Research on Ebola Virus in Liberia (PREVAIL), Monrovia, Liberia.
James D NeatonDivision of Biostatistics, School of Public Health, University of Minnesota, Minneapolis, MN, USA.
Yazdan YazdanpanahREACTing, Institut Thématique Immunologie, Inflammation, Infectiologie et Microbiologie, Inserm, Paris, France. yazdan.yazdanpanah@aphp.fr.
PREVAC study team
Planned Parenthood Association of Liberia · LRInserm · FRNational Institute of Allergy and Infectious Diseases · USLondon School of Hygiene & Tropical Medicine · GBUniversité Claude Bernard Lyon 1 · FRUniversité de Bordeaux · FRUniversity of Minnesota · USCentre Pour le Développement des Vaccins-Mali · MLUniversité des Sciences, des Techniques et des Technologies de Bamako · MLUniversity of Sierra Leone · SL

Funding

Pathogenesis, Treatment and Prevention of Emerging Infectious DiseasesZIAAI000936 · NIAID · NATIONAL INSTITUTE OF ALLERGY AND INFECTIOUS DISEASES · PI LANE, CLIFFORD · 2009 to 2025
$6.4M
Training in Clinical and Epidemiological Research for Liberia (TRACER)U2RTW011281 · FIC · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · PI MARTIN, JEFFREY N · 2019 to 2023
$1.2M
FIC NIH HHS U2R TW011281
6 · The paper itself

Abstract

introductionThe 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.

methodsThis 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.

resultsFrom 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. DISCUSSION: 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.

trial registrationClinicalTrials.gov NCT02876328 . Registered on 23 August 2016.

Indexed as

Ebola VaccinesHemorrhagic Fever, EbolaAdultAfrica, WesternChildChild, PreschoolClinical Trials, Phase II as TopicDouble-Blind MethodHealthy VolunteersHumansInfantRandomized Controlled Trials as TopicVaccinationEbola VaccinesClinical trialsEbolaProtocolRandomized controlled trialsVaccine

Identifiers

PMID33485369
PMCPMC7823170
OpenAlexW3114648574

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.