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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.
- Source :
-
Vaccine [Vaccine] 2018 Mar 07; Vol. 36 (11), pp. 1398-1404. - Publication Year :
- 2018
-
Abstract
- Background: This 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.<br />Method: In 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).<br />Result: Approximately 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.<br />Conclusion: The 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.<br /> (Copyright © 2018 Elsevier Ltd. All rights reserved.)
- Subjects :
- Animals
Antibodies, Neutralizing immunology
Antibodies, Viral immunology
Cell Line
Cells, Cultured
Child
Child, Preschool
Chlorocebus aethiops
Humans
Japanese Encephalitis Vaccines administration & dosage
Japanese Encephalitis Vaccines adverse effects
Mice
Vaccination
Vaccines, Inactivated administration & dosage
Vaccines, Inactivated adverse effects
Vero Cells
Encephalitis Virus, Japanese immunology
Encephalitis, Japanese prevention & control
Immunization, Secondary
Immunogenicity, Vaccine
Japanese Encephalitis Vaccines immunology
Vaccines, Inactivated immunology
Subjects
Details
- Language :
- English
- ISSN :
- 1873-2518
- Volume :
- 36
- Issue :
- 11
- Database :
- MEDLINE
- Journal :
- Vaccine
- Publication Type :
- Academic Journal
- Accession number :
- 29429815
- Full Text :
- https://doi.org/10.1016/j.vaccine.2018.01.075