Clinical infectious diseases : an official publication of the Infectious Diseases Society of AmericaNov 15, 2023

Immune Response and Vaccine Virus Release After One or Two Doses of the Ebola Vaccine ERVEBO in Children and Adults

mRNA Technology Weekly Brief ↗PubMed ↗DOI ↗OA ↗

Updated Apr 6, 2026

Abstract

A single dose of the vaccine increased antibody responses in 819 children and 783 adults, sustained through Month 12.

Antibody responses in children were superior to those of the placebo group and non-inferior to responses in vaccinated adults.
A second dose of the vaccine given on Day 56 provided a transient boost in antibody concentrations.
Vaccine virus shedding was observed in 31.7% of children, peaking by Day 7 after the first dose.
No vaccine virus shedding was detected after Day 28 post-dose 1 or at any time following dose 2.
The findings support the potential use of the rVSVΔG-ZEBOV-GP vaccine for preventing Ebola virus disease in at-risk children.

Simplified

BACKGROUND: The 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 ( 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).

Key numbers

1.42

Antibody Response Increase

GMT ratio of children to adults at Day 28 post-dose 1

31.7%

Vaccine Virus Shedding

Percentage of children with detectable vaccine virus shedding post-dose 1

96.0%

Completion Rate

Percentage of participants who completed the study through Month 12

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Immune Response and Vaccine Virus Release After One or Two Doses of the Ebola Vaccine ERVEBO in Children and Adults

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