Long-term immunogenicity of an initial booster dose of an inactivated,Vero cell culture-derived Japanese encephalitis vaccine (JE-VC) and the safety and immunogenicity of a second JE-VC booster dose in children previously vaccinated with an inactivated,mouse brain-derived Japanese encephalitis vaccine |
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| Affiliation: | 1. Department of Pediatrics, Seoul National University College of Medicine, Seoul, Republic of Korea;2. Department of Pediatrics, Gachon University College of Medicine, Incheon, Republic of Korea;3. Departments of Pediatrics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Republic of Korea;4. Department of Pediatrics, School of Medicine, Ewha Womans University, Seoul, Republic of Korea;5. Department of Pediatrics, Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Republic of Korea;6. Department of Pediatrics, Inha University College of Medicine, Incheon, Republic of Korea;7. Department of Pediatrics, Korea Cancer Center Hospital, Seoul, Republic of Korea;8. Department of Pediatrics, Yonsei University Wonju College of Medicine, Wonju, Republic of Korea;9. Department of Pediatrics, College of Medicine, Kyunghee University, Seoul, Republic of Korea;1. Univ. Lille, U1019 – UMR 8204 – CIIL – Centre d''Infection et d''Immunité de Lille, F-59000 Lille, France;2. CNRS, UMR 8204, F-59000 Lille, France;3. Inserm, U1019, F-59000 Lille, France;4. CHU Lille, F-59000 Lille, France;5. Institut Pasteur de Lille, F-59000 Lille, France;6. RIVM, Bilthoven, The Netherlands;7. Public Health England, Porton Down, Salisbury SP4 0JG, United Kingdom;1. Department of Microbiology, Faculty of Science, Federal University, Birnin Kebbi P.M.B. 1157 Kalgo Road, Birnin Kebbi, Kebbi State, Nigeria;2. Immunization, Vaccines and Emergencies, World Health Organization, Kebbi State Field Office, Nigeria;3. Department of Demography and Social Statistics, Faculty of Art, Social and Management Sciences, Federal University, Birnin Kebbi P.M.B. 1157 Kalgo Road, Birnin Kebbi, Kebbi State, Nigeria;1. The Israel Center for Disease Control, Israel Ministry of Health, Tel-Hashomer, Israel;2. Central Virology Laboratory, Ministry of Health, Chaim Sheba Medical Center, Ramat-Gan, Israel;3. Department of Epidemiology and Preventive Medicine, School of Public Health, Sackler Faculty of Medicine, Tel-Aviv University, Tel-Aviv, Israel;1. Cancer Research, Saskatchewan Cancer Agency, Canada;2. Department of Oncology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada;3. Department of Pathology, University of Saskatchewan, Saskatoon, Saskatchewan, Canada;4. Department of Oncology, The First Affiliated Hospital of Soochow University, Suzhou, China;5. Molecular Physiology and Therapeutics Branch, National Institute of Dental Craniofacial Research, National Institute of Health, Bethesda, MD, USA;1. Division of Infectious Diseases, Department of Pediatrics, Faculty of Medicine, Chulalongkorn University, Rama IV Road, Bangkok 10330, Thailand;2. Research Unit in Pediatric Infectious Diseases and Vaccine, Chulalongkorn University, Bangkok, Thailand;3. Center for Vaccine Development, Institute of Molecular Biosciences, Mahidol University, Bangkok, Thailand |
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| Abstract: | BackgroundThis study was performed with the aim of determining the long-term immunogenicity of an inactivated, Vero cell culture-derived Japanese encephalitis (JE) vaccine (JE-VC) and an inactivated, mouse brain-derived JE vaccine (JE-MB) after the 1st booster dose at 2 years of age, as well as the safety and immunogenicity of the 2nd booster dose of JE-VC at 6 years of age, in children primed and given a 1st booster dose of either JE-VC or JE-MB.MethodIn this multicenter, open-label clinical trial, the study population consisted of healthy Korean children (aged 6 years) who participated in the previous JE vaccine trial. All subjects were subcutaneously vaccinated once for the booster immunization with Boryung Cell Culture Japanese Encephalitis Vaccine® (JE-VC).ResultApproximately 4 years after the 1st booster dose of JE-VC, the seroprotection rate (SPR) and geometric mean titer (GMT) of the neutralizing antibody were 100% and 1113.8, respectively. In children primed and given a 1st booster dose of JE-MB, the SPR and GMT were 88.5% and 56.3, respectively. After the 2nd booster dose of JE-VC, all participants primed and given a 1st booster dose of either JE-MB or JE-VC were seroprotective against JE virus. The GMT of the neutralizing antibody was higher in children primed and given a 1st booster dose of JE-VC (8144.1) than in those primed and given a 1st booster dose of JE-MB (942.5) after the vaccination (p < 0.001). In addition, the 2nd booster dose of JE-VC showed a good safety profile with no serious vaccine-related adverse events.ConclusionThe 1st booster dose of JE-VC and JE-MB showed long-term immunogenicity of at least 4 years, and the 2nd booster dose of JE-VC showed a good safety and immunogenicity profile in children primed and given a 1st booster dose of either JE-VC or JE-MB.ClinicalTtrials.gov Identifier: NCT02532569 |
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