Neutralizing antibody persistence in pediatric travelers from non-JE-endemic countries following vaccination with IXIARO® Japanese encephalitis vaccine: An uncontrolled, open-label phase 3 follow-up study.
Adolescent
Antibodies, Neutralizing
/ blood
Antibodies, Viral
/ immunology
Australia
Child
Child, Preschool
Encephalitis Virus, Japanese
/ immunology
Encephalitis, Japanese
/ immunology
Endemic Diseases
Europe
Female
Follow-Up Studies
Humans
Japanese Encephalitis Vaccines
/ pharmacology
Male
Pediatrics
United States
Antibody persistence
Children
IXIARO®
Immunogenicity
Japanese encephalitis vaccine
Seroprotection
Journal
Travel medicine and infectious disease
ISSN: 1873-0442
Titre abrégé: Travel Med Infect Dis
Pays: Netherlands
ID NLM: 101230758
Informations de publication
Date de publication:
Historique:
received:
19
12
2019
revised:
18
02
2020
accepted:
03
03
2020
pubmed:
12
3
2020
medline:
26
5
2021
entrez:
12
3
2020
Statut:
ppublish
Résumé
In an initial study among children from non-Japanese encephalitis (JE)-endemic countries, seroprotection rates remained high 6 months after completion of the primary series with IXIARO®. In this open-label follow-up study, a subset of 23 children who received a 2-dose primary series of IXIARO® in the parent study, were evaluated for safety and neutralizing antibody persistence for 36 months. Seroprotection rates (SPRs) remained high but declined from 100% one month after primary immunization to 91.3% at month 7 and 89.5% at month 36. Geometric mean titers (GMTs) declined considerably from 384.1 by day 56-60.8 at month 36. No long-term safety concerns were identified. The substantial decline in GMT observed in this study, together with previously published data on children vaccinated with IXIARO® support the recommendation for a booster dose in children who remain at risk of JE from 1 year after the primary series of IXIARO®, consistent with the recommendation for adults. NCT01246479.
Sections du résumé
BACKGROUND
In an initial study among children from non-Japanese encephalitis (JE)-endemic countries, seroprotection rates remained high 6 months after completion of the primary series with IXIARO®.
METHODS
In this open-label follow-up study, a subset of 23 children who received a 2-dose primary series of IXIARO® in the parent study, were evaluated for safety and neutralizing antibody persistence for 36 months.
RESULTS
Seroprotection rates (SPRs) remained high but declined from 100% one month after primary immunization to 91.3% at month 7 and 89.5% at month 36. Geometric mean titers (GMTs) declined considerably from 384.1 by day 56-60.8 at month 36. No long-term safety concerns were identified.
CONCLUSIONS
The substantial decline in GMT observed in this study, together with previously published data on children vaccinated with IXIARO® support the recommendation for a booster dose in children who remain at risk of JE from 1 year after the primary series of IXIARO®, consistent with the recommendation for adults.
CLINICAL TRIAL REGISTRY NUMBER
NCT01246479.
Identifiants
pubmed: 32156630
pii: S1477-8939(20)30084-3
doi: 10.1016/j.tmaid.2020.101616
pii:
doi:
Substances chimiques
Antibodies, Neutralizing
0
Antibodies, Viral
0
Japanese Encephalitis Vaccines
0
Banques de données
ClinicalTrials.gov
['NCT01246479']
Types de publication
Clinical Trial, Phase III
Journal Article
Multicenter Study
Research Support, Non-U.S. Gov't
Langues
eng
Sous-ensembles de citation
IM
Pagination
101616Informations de copyright
Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
Déclaration de conflit d'intérêts
Declaration of competing interest CT, DR, SEL, SK, VK and KD are employees of Valneva SE or its affiliates, the manufacturer of IXIARO®.