4.5 Article

The Immunogenicity and Safety of the Live-attenuated SA 14-14-2 Japanese Encephalitis Vaccine Given with a Two-dose Primary Schedule in Children

期刊

JOURNAL OF KOREAN MEDICAL SCIENCE
卷 30, 期 5, 页码 612-616

出版社

KOREAN ACAD MEDICAL SCIENCES
DOI: 10.3346/jkms.2015.30.5.612

关键词

Live Attenuated Japanese Encephalitis Vaccine; Immunogenicity; Safety; Children; Clinical Trial

资金

  1. Korea Food & Drug Administration [08122-vaccine assessment-337]

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Effective and tolerable vaccination is an essential strategy to prevent Japanese encephalitis (JE) in endemic areas. Although the live attenuated SA 14-14-2 JE vaccine (LAJEV) has been widely used since its introduction, the systemic data of LAJEV was very rarely available in Korea. We conducted the open-label, prospective cohort study to assess the immunogenicity and safety of this vaccine. Ninety subjects were enrolled, and LAJEV in a 2-dose primary series was given with a 12-month interval. Neutralizing antibody titers were measured before and after each vaccination, and active monitoring for adverse events was performed. After the first dose, 91.1% of subjects had seroprotection with a geometric mean titer (GMT) of 40.9. Seroprotection rate after the second dose was 97%, and GMT showed an increase of 6.5-fold. Most adverse events following immunization were self-limited, and no serious adverse events were reported until 42 days after each dose. The 2-dose administration of LAJEV in the primary immunization schedule appeared to be highly immunogenic and safe.

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