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유전자재조합 B형 간염바이러스 백신(HG -Ⅱ)의 면역원성 및 안전성

Other Titles
 Immunogenicity and Safety of a 20 ㎍ Dose of the Green Cross Recombinant Hepatitis B Vaccine ( HG -Ⅱ ) in Healthy Adults 
Authors
 이계희  ;  이옥재  ;  김영채  ;  남궁란  ;  손영모 
Citation
 Korean Journal of Hepatology (대한간학회지), Vol.3(1) : 58-64, 1997 
Journal Title
 Korean Journal of Hepatology (대한간학회지) 
ISSN
 1738-222X 
Issue Date
1997
Abstract
Background/Aims . The introduction of Hansenula polymorpha for recombinant hepatitis B vaccine production allowed high product yield with plasmid stability and less glycosylation than conventional Saccharomyces cerevisiae system. A Green Cross HG-II vaccine formulated from HBsAg produced by a recombinant strain of the yeast H. polymorpha was evaluated for immunogenicity and safety in an open label triaL Method ' A 20 ug dose of Green Cross HG-II vaccine was administered intramuscularly at 0, 1 and 6 months at the deltoid region in 118 healthy adults seronegative for HBV markers. The anti-HBs titers were determined at one month after administration of the third dose of vaccine by radioimmunoassay. Results .' The seroconversion rate was 96.8% (90 out of 93), with seroprotective rate of 95.7% (89 out of 93). The geometric mean titers(GMT) of the anti-HBs response was 153.1mIU/ml in seroconverters. An age-dependent effect was observed in the anti-HBs response. But sex-dependent effect was not prominent. Reactogenecity was in incidence and general reactions were short-lasting and a mainly mild in severity. Conclusions .' The results of this study have shown that the Green Cross HG-II vaccine is safe and clinically well tolerated, a nd that it may provide protection against HBV infection.
Files in This Item:
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Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Pediatrics (소아청소년과학교실) > 1. Journal Papers
Yonsei Authors
Namgung, Ran(남궁란) ORCID logo https://orcid.org/0000-0001-7182-9535
Sohn, Young Mo(손영모)
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/177494
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