Korean J Med.
2000 Jan;58(1):12-18.
Immunogenicity and safety of recombinant hepatitis B vaccine (HG-II)
in healthy adults according to 0-1-2 months vaccination schedule
- Affiliations
-
- 1Department of Internal Medicine, Gyeongsang National University College of Medicine, Chinju, Korea.
- 2Department of Internal Medicine, Chungbuk National University College of Medicine, Chongju, Korea.
- 3Department of Internal Medicine, Kyunghee University College of Medicine, Seoul, Korea.
- 4Department of Internal Medicine, Ajou University College of Medicine, Suwon, Korea.
Abstract
-
BACKGROUND: Green Cross HG-II vaccine is recombinant hepatitis B vaccine
derived from yeast Hansenula polymorpha. Its immunogenicity and safety using
0-1-6 months vaccination schedule were proven. This prospective study is
conducted to evaluate immunogenicity and safety of HG-II according to 0-1-2
months schedule.
METHODS
20 g of HG-II vaccine was given intramuscularly
at 0, 1, and 2 months to 118 healthy adults seronegative for hepatitis B markers.
Sera were assessed for anti-HBs by radioimmunoassay at 1 months and 7-10 months
after completion of vaccination.
RESULTS
113 of 118 (95.8%) completed
vaccination schedules. The seroconversion rate at 1 month after completion
of vaccination was 93.8% (106/113) and protective titers of anti-HBs developed
in 82.3% (93/113). The geometric mean titer (GMT) of anti-HBs was 64.91
mIU/ml in all seroconverted vaccinee. There was no incapacitating serious
side effect associated with vaccinations. The seropositive rate at 7-10 months
after vaccination was 95.3% (81/85) with protective rate of 84.7% (72/85).
The anti-HBs titers were decreased in 51.8% (44/85) of vaccinee. The GMT was
80.04 mIU/ml. The protective rate and GMT were 98.0%, 129.43 mIU/ml in the group
with anti-HBs titer > or = 50 mIU/ml at 1 month after vaccination, and 64.71%, 19.62
mIU/ml in the group with anti-HBs <50 mIU/ml.
CONCLUSION
Green Cross HG-II vaccine is safe and effective in protecting
hepatitis B at 0-1-2 months vaccination schedule.
However, the booster injection should be recommended for maintenance of immunogenicity,
especially in the vaccinee with anti-HBs titer less than 50 mIU/ml at 1 month after
vaccination.