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.
Vaccine
; 36(11): 1398-1404, 2018 03 07.
Article
in En
| MEDLINE
| ID: mdl-29429815
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 2â¯years of age, as well as the safety and immunogenicity of the 2nd booster dose of JE-VC at 6â¯years of age, in children primed and given a 1st booster dose of either JE-VC or JE-MB.METHOD:
In this multicenter, open-label clinical trial, the study population consisted of healthy Korean children (aged 6â¯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).RESULT:
Approximately 4â¯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 (pâ¯<â¯0.001). In addition, the 2nd booster dose of JE-VC showed a good safety profile with no serious vaccine-related adverse events.CONCLUSION:
The 1st booster dose of JE-VC and JE-MB showed long-term immunogenicity of at least 4â¯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.Key words
Full text:
1
Collection:
01-internacional
Database:
MEDLINE
Main subject:
Vaccines, Inactivated
/
Immunization, Secondary
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Encephalitis, Japanese
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Japanese Encephalitis Vaccines
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Encephalitis Virus, Japanese
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Immunogenicity, Vaccine
Type of study:
Clinical_trials
Limits:
Animals
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Child
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Child, preschool
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Humans
Language:
En
Journal:
Vaccine
Year:
2018
Document type:
Article