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
en Ko
| WPRIM
| ID: wpr-12275
Biblioteca responsable:
WPRO
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.
Palabras clave
Texto completo:
1
Índice:
WPRIM
Asunto principal:
Pichia
/
Plásmidos
/
Saccharomyces cerevisiae
/
Levaduras
/
Glicosilación
/
Radioinmunoensayo
/
Incidencia
/
Vacunas contra Hepatitis B
/
Hepatitis
/
Hepatitis B
Tipo de estudio:
Incidence_studies
/
Prognostic_studies
Límite:
Adult
/
Humans
Idioma:
Ko
Revista:
The Korean Journal of Hepatology
Año:
1997
Tipo del documento:
Article