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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.
- Source :
-
Travel medicine and infectious disease [Travel Med Infect Dis] 2020 Mar - Apr; Vol. 34, pp. 101616. Date of Electronic Publication: 2020 Mar 07. - Publication Year :
- 2020
-
Abstract
- 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®.<br />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.<br />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.<br />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.<br />Clinical Trial Registry Number: NCT01246479.<br />Competing Interests: Declaration of competing interest CT, DR, SEL, SK, VK and KD are employees of Valneva SE or its affiliates, the manufacturer of IXIARO®.<br /> (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Subjects :
- Adolescent
Antibodies, Viral immunology
Australia
Child
Child, Preschool
Endemic Diseases
Europe
Female
Follow-Up Studies
Humans
Male
Pediatrics
United States
Antibodies, Neutralizing blood
Encephalitis Virus, Japanese immunology
Encephalitis, Japanese immunology
Encephalitis, Japanese prevention & control
Japanese Encephalitis Vaccines pharmacology
Subjects
Details
- Language :
- English
- ISSN :
- 1873-0442
- Volume :
- 34
- Database :
- MEDLINE
- Journal :
- Travel medicine and infectious disease
- Publication Type :
- Academic Journal
- Accession number :
- 32156630
- Full Text :
- https://doi.org/10.1016/j.tmaid.2020.101616