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Pediatr Infect Dis J. 2018 Sep;37(9):e233-e240. doi: 10.1097/INF.0000000000002124.

Antibody Persistence up to 3 Years After Primary Immunization With Inactivated Japanese Encephalitis Vaccine IXIARO in Philippine Children and Effect of a Booster Dose.

Author information

1
From the Valneva Austria GmbH, Vienna, Austria.
2
Department of Health, Research Institute for Tropical Medicine, Manila, Philippines.
3
Department of Pediatrics.
4
College of Medicine, University of the Philippines, Manila, Philippines.
5
Section of Infectious and Tropical Diseases, Department of Pediatrics, Philippine General Hospital, Manila, Philippines.
6
Department of Health, Research Institute for Tropical Medicine, Muntinlupa, Philippines.
7
Center for Public Health, Medical University of Vienna, Austria.

Abstract

BACKGROUND:

An inactivated Vero cell culture derived Japanese encephalitis virus vaccine (IXIARO) requires a booster dose 1 year after primary schedule for long-term antibody persistence in adults. The aim of this study is to evaluate immunogenicity and safety of a booster dose in children 2 months to <18 years of age.

METHODS:

This is a randomized, controlled open-label study in the Philippines. Three hundred children vaccinated with IXIARO in a previous trial were randomized 1:1 to receive either no booster or a booster 12 months after initiation of the primary series. Neutralizing antibody titers were assessed before and after the booster and up to 3 years after primary series. Safety endpoints included the rate of subjects with solicited adverse events (AEs), unsolicited AEs and serious AEs within 1 month after the booster.

RESULTS:

Geometric mean titer declined by 1 year after the primary series, but titers remained above the established protective threshold in 85%-100% of children depending on age group. The booster led to a pronounced increase in geometric mean titer and 100% seroprotection rate in all age groups. The booster was well tolerated, with AE rates lower compared with the primary series. Most AEs were mild.

CONCLUSIONS:

A booster dose of IXIARO administered 12 months after the primary immunization was well tolerated and highly immunogenic.

PMID:
29912844
DOI:
10.1097/INF.0000000000002124
[Indexed for MEDLINE]

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