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Randomized Trial of Vaccines for Zaire Ebola Virus Disease

dc.rights.licenseopenen_US
dc.contributor.authorKIEH, Mark
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorRICHERT, Laura
dc.contributor.authorBEAVOGUI, Abdoul H.
dc.contributor.authorGRUND, Birgit
dc.contributor.authorLEIGH, Bailah
dc.contributor.authorD’ORTENZIO, Eric
dc.contributor.authorDOUMBIA, Seydou
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLHOMME, Edouard
dc.contributor.authorSOW, Samba
dc.contributor.authorVATRINET, Renaud
dc.contributor.authorROY, Celine
dc.contributor.authorKENNEDY, Stephen B.
dc.contributor.authorFAYE, Sylvain
dc.contributor.authorLEES, Shelley
dc.contributor.authorMILLIMOUNO, Niouma P.
dc.contributor.authorCAMARA, Alseny M.
dc.contributor.authorSAMAI, Mohamed
dc.contributor.authorDEEN, Gibrilla F.
dc.contributor.authorDOUMBIA, Moussa
dc.contributor.authorESPEROU, Helene
dc.contributor.authorPIERSON, Jerome
dc.contributor.authorWATSON-JONES, Deborah
dc.contributor.authorDIALLO, Alpha
dc.contributor.authorWENTWORTH, Deborah
dc.contributor.authorMCLEAN, Chelsea
dc.contributor.authorSIMON, Jakub
dc.contributor.authorWIEDEMANN, Aurélie
dc.contributor.authorDIGHERO-KEMP, Bonnie
dc.contributor.authorHENSLEY, Lisa
dc.contributor.authorLANE, Clifford
dc.contributor.authorLEVY, Yves
dc.contributor.authorPIOT, Peter
dc.contributor.authorGREENWOOD, Brian
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorCHENE, Genevieve
dc.contributor.authorNEATON, James
dc.contributor.authorYAZDANPANAH, Yazdan
dc.date.accessioned2023-03-06T08:34:16Z
dc.date.available2023-03-06T08:34:16Z
dc.date.issued2022-12-29
dc.identifier.issn0028-4793en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/172159
dc.description.abstractEnBackground : Questions remain concerning the rapidity of immune responses and the durability and safety of vaccines used to prevent Zaire Ebola virus disease. Methods : We conducted two randomized, placebo-controlled trials — one involving adults and one involving children — to evaluate the safety and immune responses of three vaccine regimens against Zaire Ebola virus disease: Ad26.ZEBOV followed by MVA-BN-Filo 56 days later (the Ad26–MVA group), rVSVΔG-ZEBOV-GP followed by placebo 56 days later (the rVSV group), and rVSVΔG-ZEBOV-GP followed by rVSVΔG-ZEBOV-GP 56 days later (the rVSV–booster group). The primary end point was antibody response at 12 months, defined as having both a 12-month antibody concentration of at least 200 enzyme-linked immunosorbent assay units (EU) per milliliter and an increase from baseline in the antibody concentration by at least a factor of 4. Results : A total of 1400 adults and 1401 children underwent randomization. Among both adults and children, the incidence of injection-site reactions and symptoms (e.g., feverishness and headache) was higher in the week after receipt of the primary and second or booster vaccinations than after receipt of placebo but not at later time points. These events were largely low-grade. At month 12, a total of 41% of adults (titer, 401 EU per milliliter) and 78% of children (titer, 828 EU per milliliter) had a response in the Ad26–MVA group; 76% (titer, 992 EU per milliliter) and 87% (titer, 1415 EU per milliliter), respectively, had a response in the rVSV group; 81% (titer, 1037 EU per milliliter) and 93% (titer, 1745 EU per milliliter), respectively, had a response in the rVSV–booster group; and 3% (titer, 93 EU per milliliter) and 4% (titer, 67 EU per milliliter), respectively, had a response in the placebo group (P<0.001 for all comparisons of vaccine with placebo). In both adults and children, antibody responses with vaccine differed from those with placebo beginning on day 14. Conclusions : No safety concerns were identified in this trial. With all three vaccine regimens, immune responses were seen from day 14 through month 12. (Funded by the National Institutes of Health and others; PREVAC ClinicalTrials.gov number, NCT02876328. opens in new tab; EudraCT numbers, 2017-001798-18. opens in new tab and 2017-001798-18/3rd. opens in new tab; and Pan African Clinical Trials Registry number, PACTR201712002760250. opens in new tab.)
dc.language.isoENen_US
dc.title.enRandomized Trial of Vaccines for Zaire Ebola Virus Disease
dc.typeArticle de revueen_US
dc.identifier.doi10.1056/NEJMoa2200072en_US
dc.subject.halSciences du Vivant [q-bio]en_US
dc.identifier.pubmed36516078en_US
bordeaux.journalNew England Journal of Medicineen_US
bordeaux.page2411-2424en_US
bordeaux.volume387en_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.import.sourcehal
hal.identifierhal-03901595
hal.version1
hal.exportfalse
workflow.import.sourcehal
dc.rights.ccPas de Licence CCen_US
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