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A Collaborative Study on Korean Standard JE Vaccine for Potency Assay
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  • A Collaborative Study on Korean Standard JE Vaccine for Potency Assay
  • A Collaborative Study on Korean Standard JE Vaccine for Potency Assay
저자명
Kim. Jae-Ok,Shin. Jin-Ho,Baek. Sun-Young,Min. Kyung-Il,Min. Bok-Soon,Ryu. Seung-Rel,Kim. Byoung-Guk,Kim. Do-Keun,Ahn. Mi-Jin,Par
간행물명
Journal of microbiology and biotechnology
권/호정보
2004년|14권 4호|pp.745-750 (6 pages)
발행정보
한국미생물생명공학회
파일정보
정기간행물|ENG|
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기타
이 논문은 한국과학기술정보연구원과 논문 연계를 통해 무료로 제공되는 원문입니다.
서지반출

기타언어초록

The objective of this collaborative study was to establish a Korean standard of Japanese encephalitis (JE) vaccine (mouse brain-derived, formalin-inactivated) for potency assay. A candidate preparation proposed as a Korean standard was provided by GreenCross Vaccine, and six laboratories, including one national control laboratory and five manufacturers of JE vaccine, participated in the study. The potency of the candidate preparation and a reference standard obtained from Japan was estimated by mouse immunogenicity assay using the in vitro plaque reduction neutralization test (PRNT). The results of 72 assays conducted by the 6 laboratories showed that the overall mean potency estimate of the candidate preparation was 2.455 log median plaque reduction neutralization antibody titer per 0.5-ml dosage administered twice in mice at 7-day intervals, and that the mean potency ratio of the candidate preparation relative to the reference standard was 1.074. The potency estimates were quite variable among laboratories irrespective of the preparation. The variability of assays assessed by Z scores and coefficient of variation (CV) were in general within the level of acceptance (Z scores within $pm3$ and $CV;leq;15%$). Therefore, we concluded that the candidate preparation would be suitable as a national standard for testing the potency of JE vaccine (inactivated).