Original Articles: Immunogenicity and Safety of a 20 microgram Dose of the Green Cross Recombinant Hepatitis B Vaccine ( HG -II ) in Healthy Adults.
- Author:
Kye Heui LEE
;
Ok Jae LEE
;
Young Chai KIM
;
Ran NAMGUNG
;
Young Mo SOHN
- Publication Type:Original Article
- Keywords:
Recombinant Hepatitis B Vaccine;
Hansenula polymorpha system
- MeSH:
Adult*;
Glycosylation;
Hepatitis B Surface Antigens;
Hepatitis B Vaccines*;
Hepatitis B*;
Hepatitis*;
Humans;
Incidence;
Pichia;
Plasmids;
Radioimmunoassay;
Saccharomyces cerevisiae;
Yeasts
- From:The Korean Journal of Hepatology
1997;3(1):58-64
- CountryRepublic of Korea
- Language:Korean
-
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 METHOFD: 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.
