PMID- 29912844 OWN - NLM STAT- MEDLINE DCOM- 20190516 LR - 20190516 IS - 1532-0987 (Electronic) IS - 0891-3668 (Linking) VI - 37 IP - 9 DP - 2018 Sep TI - Antibody Persistence up to 3 Years After Primary Immunization With Inactivated Japanese Encephalitis Vaccine IXIARO in Philippine Children and Effect of a Booster Dose. PG - e233-e240 LID - 10.1097/INF.0000000000002124 [doi] AB - 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. FAU - Kadlecek, Vera AU - Kadlecek V AD - From the Valneva Austria GmbH, Vienna, Austria. FAU - Borja-Tabora, Charissa Fay AU - Borja-Tabora CF AD - Department of Health, Research Institute for Tropical Medicine, Manila, Philippines. FAU - Eder-Lingelbach, Susanne AU - Eder-Lingelbach S AD - From the Valneva Austria GmbH, Vienna, Austria. FAU - Gatchalian, Salvacion AU - Gatchalian S AD - Department of Pediatrics. AD - College of Medicine, University of the Philippines, Manila, Philippines. AD - Section of Infectious and Tropical Diseases, Department of Pediatrics, Philippine General Hospital, Manila, Philippines. AD - Department of Health, Research Institute for Tropical Medicine, Muntinlupa, Philippines. FAU - Kiermayr, Sigrid AU - Kiermayr S AD - From the Valneva Austria GmbH, Vienna, Austria. FAU - Sablan, Benjamin Jr AU - Sablan B Jr AD - Department of Pediatrics. FAU - Kundi, Michael AU - Kundi M AD - Center for Public Health, Medical University of Vienna, Austria. FAU - Taucher, Christian AU - Taucher C AD - From the Valneva Austria GmbH, Vienna, Austria. FAU - Dubischar, Katrin L AU - Dubischar KL AD - From the Valneva Austria GmbH, Vienna, Austria. LA - eng PT - Journal Article PT - Randomized Controlled Trial PT - Research Support, Non-U.S. Gov't PL - United States TA - Pediatr Infect Dis J JT - The Pediatric infectious disease journal JID - 8701858 RN - 0 (Antibodies, Neutralizing) RN - 0 (Antibodies, Viral) RN - 0 (Japanese Encephalitis Vaccines) RN - 0 (Vaccines, Inactivated) SB - IM MH - Adolescent MH - Antibodies, Neutralizing/blood MH - Antibodies, Viral/*blood MH - Child MH - Child, Preschool MH - Encephalitis, Japanese/immunology/*prevention & control MH - Humans MH - Immunization, Secondary MH - *Immunogenicity, Vaccine MH - Infant MH - Japanese Encephalitis Vaccines/administration & dosage/*therapeutic use MH - Male MH - Philippines MH - Vaccines, Inactivated/administration & dosage/therapeutic use EDAT- 2018/06/19 06:00 MHDA- 2019/05/17 06:00 CRDT- 2018/06/19 06:00 PHST- 2018/06/19 06:00 [pubmed] PHST- 2019/05/17 06:00 [medline] PHST- 2018/06/19 06:00 [entrez] AID - 10.1097/INF.0000000000002124 [doi] PST - ppublish SO - Pediatr Infect Dis J. 2018 Sep;37(9):e233-e240. doi: 10.1097/INF.0000000000002124.