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

Ebola immunogenicity pediatrics vaccine vaccine shedding

Journal

Clinical infectious diseases : an official publication of the Infectious Diseases Society of America

ISSN: 1537-6591

Titre abrégé: Clin Infect Dis

Pays: United States

ID NLM: 9203213

Informations de publication

Date de publication:
15 Nov 2023

Historique:

received: 23 08 2023

revised: 30 10 2023

accepted: 10 11 2023

medline: 15 11 2023

pubmed: 15 11 2023

entrez: 15 11 2023

Statut: aheadofprint

Résumé

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. 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. 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. 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.

Sections du résumé

BACKGROUND BACKGROUND

METHODS 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 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 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.

Identifiants

DOI: 10.1093/cid/ciad693 PMID: 37967326

pubmed: 37967326

pii: 7424057

doi: 10.1093/cid/ciad693

pii:

doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

Investigateurs

Jamila Aboulhab (J)

Michelle Aguirre-MacKenzie (M)

Pauline Akoo (P)

Esther Akpa (E)

Robert Akpata (R)

Sara Albert (S)

Boni Maxime Ale (BM)

Serry Alimamy-Bangura (S)

Pierre Andong (P)

Benetta C Andrews (BC)

Stephane Anoma (S)

Negin Atri (N)

Augustin Augier (A)

Ken Awuondo (K)

Moses Badio (M)

Aminata Bagayoko (A)

Abby Balde (A)

Joséphine Balssa (J)

Lamin Molecule Bangura (LM)

Kesha Barrington (K)

Eric Barte de Saint Fare (EB)

Beth Baseler (B)

Ali Bauder (A)

Claire Bauduin (C)

Luke Bawo (L)

Abdoul Habib Beavogui (AH)

Michael Belson (M)

Marion Bererd (M)

Teedoh Beyslow (T)

Jeanne Billioux (J)

Shere Billouin-Frazier (S)

Blandine Binachon (B)

Julie Blie (J)

Viki Bockstal (V)

Patricia Boison (P)

Fatorma Bolay (F)

Aliou Boly (A)

Anne-Gaëlle Borg (AG)

Samuel Bosompem (S)

Courtney Bozman (C)

Tyler Brady (T)

Sarah Browne (S)

Barbara Cagniard (B)

Kelly Cahill (K)

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