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Immunogenicity and vaccine shedding after 1 or 2 doses of rVZVDeltaG-ZEBOV-GP Ebola vaccine (ERVEBO(R)): Results from a phase 2, randomized, placebo-controlled trial in children and adults

dc.rights.licenseopenen_US
dc.contributor.authorLEE, Andrew W
dc.contributor.authorLIU, Ken
hal.structure.identifierStatistics In System biology and Translational Medicine [SISTM]
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLHOMME, Edouard
dc.contributor.authorBLIE, Julie
dc.contributor.authorMCCULLOUGH, John
dc.contributor.authorONORATO, Matthew T
dc.contributor.authorCONNOR, Laurie
dc.contributor.authorSIMON, Jakub
dc.contributor.authorDUBEY, Sheri
dc.contributor.authorVANRHEENEN, Susan
dc.contributor.authorDEUTSCH, Jonathan
dc.contributor.authorOWENS, Abigail
dc.contributor.authorMORGAN, Amy
dc.contributor.authorWELEBOB, Carolee
dc.contributor.authorHYATT, Donna
dc.contributor.authorNAIR, Sunita
dc.contributor.authorHAMZE, Benjamin
dc.contributor.authorGUINDO, Oumar
dc.contributor.authorSOW, Samba O
dc.contributor.authorBEAVOGUI, Abdoul H
dc.contributor.authorLEIGH, Bailah
dc.contributor.authorSAMAI, Mohamed
dc.contributor.authorAKOO, Pauline
dc.contributor.authorSERRY-BANGURA, Alimamy
dc.contributor.authorFLECK, Suzanne
dc.contributor.authorSECKA, Fatou
dc.contributor.authorLOWE, Brett
dc.contributor.authorWATSON-JONES, Deborah
dc.contributor.authorROY, Celine
dc.contributor.authorHENSLEY, Lisa E
dc.contributor.authorKIEH, Mark
dc.contributor.authorCOLLER, Beth-Ann G
dc.date.accessioned2024-01-15T14:27:24Z
dc.date.available2024-01-15T14:27:24Z
dc.date.issued2023-11-15
dc.identifier.issn1537-6591en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/187172
dc.description.abstractEnBACKGROUND: The rVSVΔG-ZEBOV-GP vaccine (ERVEBO®) is a single-dose, live-attenuated, recombinant vesicular stomatitis virus vaccine indicated for the prevention of Ebola virus disease (EVD) caused by Zaire ebolavirus in individuals 12 months of age and older. METHODS: The Partnership for Research on Ebola VACcination (PREVAC) is a multicenter, phase 2, randomized, double-blind, placebo-controlled trial of 3 vaccine strategies in healthy children (ages 1-17) and adults, with projected 5 years of follow-up (NCT02876328). Using validated assays (GP-ELISA and PRNT), we measured antibody responses after 1-dose rVSVΔG-ZEBOV-GP, 2-dose rVSVΔG-ZEBOV-GP (given on Day 0 and Day 56), or placebo. Further, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR. RESULTS: 819 children and 783 adults were randomized to receive rVSVΔG-ZEBOV-GP (1 or 2 doses) or placebo. A single dose of rVSVΔG-ZEBOV-GP increased antibody responses by Day 28 that were sustained through Month 12. A second dose of rVSVΔG-ZEBOV-GP given on Day 56 transiently boosted antibody concentrations. In vaccinated children, GP-ELISA titers were superior to placebo and non-inferior to vaccinated adults. Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7, with no shedding observed after Day 28 post-dose 1 or any time post-dose 2. CONCLUSIONS: A single dose of rVSVΔG-ZEBOV-GP induced robust antibody responses in children that was non-inferior to the responses induced in vaccinated adults. Vaccine virus shedding in children was time-limited and only observed after the first dose. Overall, these data support the use of rVSVΔG-ZEBOV-GP for the prevention of EVD in at-risk children.
dc.language.isoENen_US
dc.rightsAttribution-NonCommercial-NoDerivs 3.0 United States*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/3.0/us/*
dc.subject.enEbola
dc.subject.enVaccine
dc.subject.enPediatrics
dc.subject.enImmunogenicity
dc.subject.enVaccine shedding
dc.title.enImmunogenicity and vaccine shedding after 1 or 2 doses of rVZVDeltaG-ZEBOV-GP Ebola vaccine (ERVEBO(R)): Results from a phase 2, randomized, placebo-controlled trial in children and adults
dc.title.alternativeClin Infect Disen_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1093/cid/ciad693en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed37967326en_US
bordeaux.journalClinical Infectious Diseasesen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.institutionINRIAen_US
bordeaux.teamSISTM_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exportfalse
dc.rights.ccPas de Licence CCen_US
bordeaux.COinSctx_ver=Z39.88-2004&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.jtitle=Clinical%20Infectious%20Diseases&rft.date=2023-11-15&rft.eissn=1537-6591&rft.issn=1537-6591&rft.au=LEE,%20Andrew%20W&LIU,%20Ken&LHOMME,%20Edouard&BLIE,%20Julie&MCCULLOUGH,%20John&rft.genre=article


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