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

Autor: Elizabeth D. Barnett, Susanne Eder-Lingelbach, Christian Taucher, Deborah J Mills, Tomas Jelinek, Sigrid Kiermayr, Katrin L. Dubischar, Vera Kadlecek, Duellyn Pandis, Jakob P. Cramer, Daniela Reiner
Rok vydání: 2020
Předmět:
Zdroj: Travel Medicine and Infectious Disease. 34:101616
ISSN: 1477-8939
DOI: 10.1016/j.tmaid.2020.101616
Popis: 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 .
Databáze: OpenAIRE