Original Articles: Immunogenicity and Safety of a 20 microgram Dose of the Green Cross Recombinant Hepatitis B Vaccine ( HG -II ) in Healthy Adults / 대한간학회지
The Korean Journal of Hepatology
;
: 58-64, 1997.
Article
Dans Coréen
| WPRIM
| ID: wpr-12275
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.
Texte intégral:
Disponible
Indice:
WPRIM (Pacifique occidental)
Sujet Principal:
Pichia
/
Plasmides
/
Saccharomyces cerevisiae
/
Levures
/
Glycosylation
/
Dosage radioimmunologique
/
Incidence
/
Vaccins anti-hépatite B
/
Hépatite
/
Hépatite B
Type d'étude:
Etude d'incidence
/
Étude pronostique
Limites du sujet:
Adulte
/
Humains
langue:
Coréen
Texte intégral:
The Korean Journal of Hepatology
Année:
1997
Type:
Article
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