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
LHOMME, Edouard
Statistics In System biology and Translational Medicine [SISTM]
Bordeaux population health [BPH]
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Statistics In System biology and Translational Medicine [SISTM]
Bordeaux population health [BPH]
LHOMME, Edouard
Statistics In System biology and Translational Medicine [SISTM]
Bordeaux population health [BPH]
< Réduire
Statistics In System biology and Translational Medicine [SISTM]
Bordeaux population health [BPH]
Langue
EN
Article de revue
Ce document a été publié dans
Clinical Infectious Diseases. 2023-11-15
Résumé en anglais
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 ...Lire la suite >
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.< Réduire
Mots clés en anglais
Ebola
Vaccine
Pediatrics
Immunogenicity
Vaccine shedding
Unités de recherche