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.license | open | en_US |
dc.contributor.author | LEE, Andrew W | |
dc.contributor.author | LIU, Ken | |
hal.structure.identifier | Statistics In System biology and Translational Medicine [SISTM] | |
hal.structure.identifier | Bordeaux population health [BPH] | |
dc.contributor.author | LHOMME, Edouard | |
dc.contributor.author | BLIE, Julie | |
dc.contributor.author | MCCULLOUGH, John | |
dc.contributor.author | ONORATO, Matthew T | |
dc.contributor.author | CONNOR, Laurie | |
dc.contributor.author | SIMON, Jakub | |
dc.contributor.author | DUBEY, Sheri | |
dc.contributor.author | VANRHEENEN, Susan | |
dc.contributor.author | DEUTSCH, Jonathan | |
dc.contributor.author | OWENS, Abigail | |
dc.contributor.author | MORGAN, Amy | |
dc.contributor.author | WELEBOB, Carolee | |
dc.contributor.author | HYATT, Donna | |
dc.contributor.author | NAIR, Sunita | |
dc.contributor.author | HAMZE, Benjamin | |
dc.contributor.author | GUINDO, Oumar | |
dc.contributor.author | SOW, Samba O | |
dc.contributor.author | BEAVOGUI, Abdoul H | |
dc.contributor.author | LEIGH, Bailah | |
dc.contributor.author | SAMAI, Mohamed | |
dc.contributor.author | AKOO, Pauline | |
dc.contributor.author | SERRY-BANGURA, Alimamy | |
dc.contributor.author | FLECK, Suzanne | |
dc.contributor.author | SECKA, Fatou | |
dc.contributor.author | LOWE, Brett | |
dc.contributor.author | WATSON-JONES, Deborah | |
dc.contributor.author | ROY, Celine | |
dc.contributor.author | HENSLEY, Lisa E | |
dc.contributor.author | KIEH, Mark | |
dc.contributor.author | COLLER, Beth-Ann G | |
dc.date.accessioned | 2024-01-15T14:27:24Z | |
dc.date.available | 2024-01-15T14:27:24Z | |
dc.date.issued | 2023-11-15 | |
dc.identifier.issn | 1537-6591 | en_US |
dc.identifier.uri | https://oskar-bordeaux.fr/handle/20.500.12278/187172 | |
dc.description.abstractEn | BACKGROUND: 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.iso | EN | en_US |
dc.rights | Attribution-NonCommercial-NoDerivs 3.0 United States | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/us/ | * |
dc.subject.en | Ebola | |
dc.subject.en | Vaccine | |
dc.subject.en | Pediatrics | |
dc.subject.en | Immunogenicity | |
dc.subject.en | Vaccine shedding | |
dc.title.en | 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.title.alternative | Clin Infect Dis | en_US |
dc.type | Article de revue | en_US |
dc.identifier.doi | 10.1093/cid/ciad693 | en_US |
dc.subject.hal | Sciences du Vivant [q-bio]/Santé publique et épidémiologie | en_US |
dc.identifier.pubmed | 37967326 | en_US |
bordeaux.journal | Clinical Infectious Diseases | en_US |
bordeaux.hal.laboratories | Bordeaux Population Health Research Center (BPH) - UMR 1219 | en_US |
bordeaux.institution | Université de Bordeaux | en_US |
bordeaux.institution | INSERM | en_US |
bordeaux.institution | INRIA | en_US |
bordeaux.team | SISTM_BPH | en_US |
bordeaux.peerReviewed | oui | en_US |
bordeaux.inpress | non | en_US |
hal.popular | non | en_US |
hal.audience | Internationale | en_US |
hal.export | false | |
dc.rights.cc | Pas de Licence CC | en_US |
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