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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

dc.rights.licenseopenen_US
dc.contributor.authorBADIO, M.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLHOMME, Edouard
dc.contributor.authorKIEH, M.
dc.contributor.authorBEAVOGUI, A. H.
dc.contributor.authorKENNEDY, S. B.
dc.contributor.authorDOUMBIA, S.
dc.contributor.authorLEIGH, B.
dc.contributor.authorSOW, S. O.
dc.contributor.authorDIALLO, A.
dc.contributor.authorFUSCO, D.
dc.contributor.authorKIRCHOFF, M.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorTERMOTE, Monique
dc.contributor.authorVATRINET, R.
dc.contributor.authorWENTWORTH, D.
dc.contributor.authorESPEROU, H.
dc.contributor.authorLANE, H. C.
dc.contributor.authorPIERSON, J.
dc.contributor.authorWATSON-JONES, D.
dc.contributor.authorROY, C.
dc.contributor.authorD'ORTENZIO, E.
dc.contributor.authorGREENWOOD, B.
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorCHENE, Genevieve
dc.contributor.authorRICHERT, Laura
dc.contributor.authorNEATON, J. D.
dc.contributor.authorYAZDANPANAH, Y.
dc.contributor.authorTEAM, Prevac Study
dc.date.accessioned2021-03-01T09:54:56Z
dc.date.available2021-03-01T09:54:56Z
dc.date.issued2021-01-23
dc.identifier.issn1745-6215 (Electronic) 1745-6215 (Linking)en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/26372
dc.description.abstractEnINTRODUCTION: 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. METHODS: 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. RESULTS: 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. 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 REGISTRATION: ClinicalTrials.gov NCT02876328 . Registered on 23 August 2016.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.title.enPartnership 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
dc.title.alternativeTrialsen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1186/s13063-021-05035-9en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
bordeaux.journalTrialsen_US
bordeaux.page86en_US
bordeaux.volume22en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue1en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.teamMORPH3Eusen_US
bordeaux.teamSISTM_BPH
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.identifierhal-03154673
hal.version1
hal.date.transferred2021-03-01T09:55:02Z
hal.exporttrue
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