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Safety and immunogenicity of a freeze-dried, cell culture-derived Japanese encephalitis vaccine (Inactivated) (JEBIK(®)V) in children.
- Source :
-
Vaccine [Vaccine] 2012 Sep 07; Vol. 30 (41), pp. 5967-72. Date of Electronic Publication: 2012 Jul 25. - Publication Year :
- 2012
-
Abstract
- Freeze dried, cell culture-derived Japanese encephalitis vaccine (Inactivated) (JEBIK(®)V) is approved for a three-dose primary immunization followed by a one-dose booster immunization in Japan. We conducted a multicenter, double-blinded, randomized controlled trial of the safety and immunogenicity of the vaccine in 370 healthy children who received three doses of 5, 2.5 or 1.25 μg of virus protein per 0.5 mL formulation subcutaneously. Children received two doses of test vaccine 7-28 days apart followed by a dose 6-12 months after the second vaccination. The three-dose regimen showed a good safety profile with no serious vaccine-related adverse events. Fever and reactions at the injection site were common adverse reactions at each dose of vaccine. The seroconversion rates were 100%, 99.2% and 95.0% after two doses in the 5, 2.5 and 1.25 μg groups, respectively, and 100.0% after three doses in all groups. The geometric mean titers were high for all three formulations after the second and third doses, with a very clear dose-response relationship. These results indicate that JEBIK(®)V is likely to be a useful vaccine.<br /> (Copyright © 2012 Elsevier Ltd. All rights reserved.)
- Subjects :
- Animals
Cells, Cultured
Child
Child, Preschool
Chlorocebus aethiops
Dose-Response Relationship, Immunologic
Double-Blind Method
Encephalitis, Japanese immunology
Freeze Drying
Humans
Immunization, Secondary
Infant
Japan
Japanese Encephalitis Vaccines adverse effects
Japanese Encephalitis Vaccines immunology
Vaccination methods
Vero Cells
Viral Proteins immunology
Viral Proteins metabolism
Antibody Formation
Encephalitis, Japanese prevention & control
Japanese Encephalitis Vaccines administration & dosage
Subjects
Details
- Language :
- English
- ISSN :
- 1873-2518
- Volume :
- 30
- Issue :
- 41
- Database :
- MEDLINE
- Journal :
- Vaccine
- Publication Type :
- Academic Journal
- Accession number :
- 22841478
- Full Text :
- https://doi.org/10.1016/j.vaccine.2012.07.034