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Safety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomised, double-blind, active-controlled trial in Guinea and Sierra Leone

dc.rights.licenseopenen_US
dc.contributor.authorCHOI, Edward Man-Lik
dc.contributor.authorLACARRA, Boris
dc.contributor.authorAFOLABI, Muhammed O
dc.contributor.authorALE, Boni Maxime
dc.contributor.authorBAIDEN, Frank
dc.contributor.authorBETARD, Christine
dc.contributor.authorFOSTER, Julie
dc.contributor.authorHAMZE, Benjamin
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorSCHWIMMER, Christine
dc.contributor.authorMANNO, Daniela
dc.contributor.authorD'ORTENZIO, Eric
dc.contributor.authorISHOLA, David
dc.contributor.authorKEITA, Cheick Mohamed
dc.contributor.authorKESHINRO, Babajide
dc.contributor.authorNJIE, Yusupha
dc.contributor.authorVAN DIJCK, Wim
dc.contributor.authorGADDAH, Auguste
dc.contributor.authorANUMENDEM, Dickson
dc.contributor.authorLOWE, Brett
dc.contributor.authorVATRINET, Renaud
dc.contributor.authorLAWAL, Bolarinde Joseph
dc.contributor.authorOTIENO, Godfrey T
dc.contributor.authorSAMAI, Mohamed
dc.contributor.authorDEEN, Gibrilla Fadlu
dc.contributor.authorSWARAY, Ibrahim Bob
dc.contributor.authorKAMARA, Abu Bakarr
dc.contributor.authorKAMARA, Michael Morlai
dc.contributor.authorDIAGNE, Mame Aminata
dc.contributor.authorKOWUOR, Dickens
dc.contributor.authorMCLEAN, Chelsea
dc.contributor.authorLEIGH, Bailah
dc.contributor.authorBEAVOGUI, Abdoul Habib
dc.contributor.authorLEYSSEN, Maarten
dc.contributor.authorLUHN, Kerstin
dc.contributor.authorROBINSON, Cynthia
dc.contributor.authorDOUOGUIH, Macaya
dc.contributor.authorGREENWOOD, Brian
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorTHIEBAUT, Rodolphe
dc.contributor.authorWATSON-JONES, Deborah
dc.date.accessioned2024-01-10T11:20:58Z
dc.date.available2024-01-10T11:20:58Z
dc.date.issued2023-11
dc.identifier.issn2214-109Xen_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/187001
dc.description.abstractEnBackground This study assessed the safety and immunogenicity of the Ad26.ZEBOV and MVA-BN-Filo Ebola virus (EBOV) vaccine regimen in infants aged 4-11 months in Guinea and Sierra Leone. Methods In this phase 2, randomised, double-blind, active-controlled trial, we randomly assigned healthy infants (1:1 in a sentinel cohort, 5:2 for the remaining infants via an interactive web response system) to receive Ad26.ZEBOV followed by MVA-BN-Filo (Ebola vaccine group) or two doses of meningococcal quadrivalent conjugate vaccine (control group) administered 56 days apart. Infants were recruited at two sites in west Africa: Conakry, Guinea, and Kambia, Sierra Leone. All infants received the meningococcal vaccine 8 months after being randomly assigned. The primary objective was safety. The secondary objective was immunogenicity, measured as EBOV glycoprotein-binding antibody concentration 21 days post-dose 2, using the Filovirus Animal Non-Clinical Group ELISA. This study is registeredwithClinicalTrials.gov (NCT03929757) and the Pan African Clinical Trials Registry (PACTR201905827924069).Findings From Aug 20 to Nov 29, 2019, 142 infants were screened and 108 were randomly assigned (Ebola vaccine n=75; control n=33). The most common solicited local adverse event was injection-site pain (Ebola vaccine 15 [20%] of 75; control four [12%] of 33). The most common solicited systemic adverse events with the Ebola vaccine were irritability (26 [35%] of 75), decreased appetite (18 [24%] of 75), pyrexia (16 [21%] of 75), and decreased activity (15 [20%] of 75). In the control group, ten (30%) of 33 had irritability, seven (21%) of 33 had decreased appetite, three (9%) of 33 had pyrexia, and five (15%) of 33 had decreased activity. The frequency of unsolicited adverse events was 83% (62 of 75 infants) in the Ebola vaccine group and 85% (28 of 33 infants) in the control group. No serious adverse events were vaccine-related. In the Ebola vaccine group, EBOV glycoprotein-binding antibody geometric mean concentrations (GMCs) at 21 days post -dose 2 were 27 700 ELISA units (EU)/mL (95% CI 20 477-37 470) in infants aged 4-8 months and 20 481 EU/mL (15 325- 27 372) in infants aged 9-11 months. The responder rate was 100% (74 of 74 responded). In the control group, GMCs for both age groups were less than the lower limit of quantification and the responder rate was 3% (one of 33 responded).Interpretation Ad26.ZEBOV and MVA-BN-Filo was well tolerated and induced strong humoral responses in infants younger than 1 year. There were no safety concerns related to vaccination.
dc.language.isoENen_US
dc.rightsAttribution 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by/3.0/us/*
dc.title.enSafety and immunogenicity of the two-dose heterologous Ad26.ZEBOV and MVA-BN-Filo Ebola vaccine regimen in infants: a phase 2, randomised, double-blind, active-controlled trial in Guinea and Sierra Leone
dc.title.alternativeLancet Glob Healthen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1016/S2214-109X(23)00410-2en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed37858585en_US
dc.description.sponsorshipEuropeEU/EFPIA/Innovative Medicines Initiative 2 Joint Undertaking.en_US
bordeaux.journalLancet Global Healthen_US
bordeaux.pagee1743-e1752en_US
bordeaux.volume11en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.issue11en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionINRIAen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDHorizon 2020en_US
hal.identifierhal-04384862
hal.version1
hal.date.transferred2024-01-10T11:21:04Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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