1. 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.
- Author
-
Taucher C, Barnett ED, Cramer JP, Eder-Lingelbach S, Jelinek T, Kadlecek V, Kiermayr S, Mills DJ, Pandis D, Reiner D, and Dubischar KL
- 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
- 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®., 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., 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®., (Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.)
- Published
- 2020
- Full Text
- View/download PDF