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Immunogenicity and Vaccine Shedding After 1 or 2 Doses of rVSVΔG-ZEBOV-GP Ebola Vaccine (ERVEBO®): Results From a Phase 2, Randomized, Placebo-controlled Trial in Children and Adults.
- Source :
- Clinical Infectious Diseases; 4/15/2024, Vol. 78 Issue 4, p870-879, 10p
- Publication Year :
- 2024
-
Abstract
- 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. Furthermore, we quantified vaccine virus shedding in a subset of children's saliva using RT-PCR. Results In total, 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. Clinical Trials Registration. The study is registered at ClinicalTrials.gov (NCT02876328), the Pan African Clinical Trials Registry (PACTR201712002760250), and the European Clinical Trials Register (EudraCT number: 2017-001798-18). [ABSTRACT FROM AUTHOR]
- Subjects :
- EBOLA virus disease prevention
STOMATITIS
VIRAL physiology
RESEARCH funding
PLACEBOS
VACCINE effectiveness
STATISTICAL sampling
BLIND experiment
ENZYME-linked immunosorbent assay
RANDOMIZED controlled trials
REVERSE transcriptase polymerase chain reaction
DESCRIPTIVE statistics
ANTIBODY formation
PEDIATRICS
VACCINE immunogenicity
VIRAL vaccines
RESEARCH
ANALYSIS of variance
CONFIDENCE intervals
EBOLA virus
SALIVA
TIME
CHILDREN
ADULTS
Subjects
Details
- Language :
- English
- ISSN :
- 10584838
- Volume :
- 78
- Issue :
- 4
- Database :
- Complementary Index
- Journal :
- Clinical Infectious Diseases
- Publication Type :
- Academic Journal
- Accession number :
- 176557964
- Full Text :
- https://doi.org/10.1093/cid/ciad693