Replication, safety and immunogenicity of the vectored Ebola vaccine rVSV-ΔG-ZEBOV-GP in a sub-Saharan African paediatric population: A randomised controlled, open-label trial in children aged 1-12 years living in Lambaréné, Gabon.
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State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
State: Public
Version: Final published version
License: CC BY-NC-ND 4.0
Serval ID
serval:BIB_14DDC9627FCC
Type
Article: article from journal or magazin.
Collection
Publications
Institution
Title
Replication, safety and immunogenicity of the vectored Ebola vaccine rVSV-ΔG-ZEBOV-GP in a sub-Saharan African paediatric population: A randomised controlled, open-label trial in children aged 1-12 years living in Lambaréné, Gabon.
Journal
The Journal of infection
Working group(s)
VSV-EBOPLUS Consortium
ISSN
1532-2742 (Electronic)
ISSN-L
0163-4453
Publication state
Published
Issued date
10/2024
Peer-reviewed
Oui
Volume
89
Number
4
Pages
106237
Language
english
Notes
Publication types: Journal Article ; Randomized Controlled Trial
Publication Status: ppublish
Publication Status: ppublish
Abstract
Unlike adults, children experienced stronger and longer vector replication in plasma and shedding in saliva following rVSVΔG-ZEBOV-GP vaccination. The resulting risks of immunosuppression or immune hyperactivation leading to increased Adverse Events (AEs) and altered antibody responses are concerns that have been addressed in the present manuscript.
Children aged 1-12 years living in Gabon received either rVSVΔG-ZEBOV-GP (ERVEBO®) vaccine or the varicella-zoster virus (VZV) vaccine (VZV). The concentration of rVSVΔG vector in blood and saliva, the occurrence of AEs up to day 28; the anti-rVSVΔG-ZEBOV-GP and anti-VZV IgG antibody titres, neutralising and avidity functions of anti-rVSVΔG-ZEBOV-GP by day 365; were assessed in serum. (PACTR202005733552021) FINDINGS: In the rVSVΔG-ZEBOV-GP group, 70% and 7% of children had >0 copies/ml of rVSVΔG respectively in plasma by day 3 and in saliva by day 14 after vaccination, with no detection on day 28. Significantly higher but transient AEs occurred in the rVSVΔG-ZEBOV-GP group. Both vaccines induced seroconversion on day 28 and sustainable IgG antibody titres by day 365. Avidity and neutralisation functions of the anti-rVSVΔG-ZEBOV-GP antibodies peaked at day 28 and were maintained by day 365.
The replication and shedding do not affect the favourable risk-benefit balance of the rVSVΔG-ZEBOV-GP in children.
Children aged 1-12 years living in Gabon received either rVSVΔG-ZEBOV-GP (ERVEBO®) vaccine or the varicella-zoster virus (VZV) vaccine (VZV). The concentration of rVSVΔG vector in blood and saliva, the occurrence of AEs up to day 28; the anti-rVSVΔG-ZEBOV-GP and anti-VZV IgG antibody titres, neutralising and avidity functions of anti-rVSVΔG-ZEBOV-GP by day 365; were assessed in serum. (PACTR202005733552021) FINDINGS: In the rVSVΔG-ZEBOV-GP group, 70% and 7% of children had >0 copies/ml of rVSVΔG respectively in plasma by day 3 and in saliva by day 14 after vaccination, with no detection on day 28. Significantly higher but transient AEs occurred in the rVSVΔG-ZEBOV-GP group. Both vaccines induced seroconversion on day 28 and sustainable IgG antibody titres by day 365. Avidity and neutralisation functions of the anti-rVSVΔG-ZEBOV-GP antibodies peaked at day 28 and were maintained by day 365.
The replication and shedding do not affect the favourable risk-benefit balance of the rVSVΔG-ZEBOV-GP in children.
Keywords
Humans, Gabon, Child, Preschool, Antibodies, Viral/blood, Male, Female, Child, Infant, Ebola Vaccines/immunology, Ebola Vaccines/adverse effects, Ebola Vaccines/administration & dosage, Saliva/immunology, Saliva/virology, Ebolavirus/immunology, Ebolavirus/genetics, Immunoglobulin G/blood, Hemorrhagic Fever, Ebola/prevention & control, Virus Replication, Immunogenicity, Vaccine, Antibodies, Neutralizing/blood, Vaccination, Virus Shedding, -rVSVΔG-ZEBOV-GP antibodies, Children aged 1–12 years Lambaréné, Gabon, RVSVΔG vector, RVSVΔG-ZEBOV-GP (ERVEBO®) vaccine, Varicella-zoster virus (VZV) vaccine (VARILIX®)
Pubmed
Web of science
Open Access
Yes
Create date
19/08/2024 10:31
Last modification date
24/09/2024 7:20