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Immunogenicity of a Recombinant Hepatitis B Virus Vaccine Compared With a Plasma-derived Hepatitis B Vaccin~ and of Vaccination Schedules in Neonates

Journal of the Korean Pediatric Society 1995;38(11):1525-1534.
Published online November 15, 1995.
Immunogenicity of a Recombinant Hepatitis B Virus Vaccine Compared With a Plasma-derived Hepatitis B Vaccin~ and of Vaccination Schedules in Neonates
Ae Sil Kang1, Jong Sin Kim1, Jae Won Huh1, Chang Youn Lee1, Hyun Gi Jung1, Jae Sun Park1, Kwang Soo Hwang2
1Department of Pediatrics, Kosin University College of Medicine, Pusan, Korea
2Department of Pediatrics, Moon Hwa Hospital, Pusan, Korea
신생아기에 접종한 B형 간염 백신의 종류와 접종방법에 따른 면역 효과에 관한 연구
강애실1, 김종신1, 허재원1, 이창연1, 정현기1, 박재선1, 황광수2
1고신대학교 의과대학 소아과학교실
2부산문화병원 소아과
Abstract
Purpose
: Hepatitis B virus (HBV) vaccine was developed against HBV infection, and used widely in the world. The plasma-derived HBV vaccine was prepared from the plasma of chronic hepatitis B virus carrier. But, the plasma-derived HBV vaccine had many kinds of problems, such as the limitation of source, expensiveness, and the possibility of infection which spread through blood. To avoid these problems, the recombinant HBV vaccine was developed. We Performed this study to compare the antibody titers after vaccination of the plasma-derived HBV vaccine with that of the recombinant HBV vaccine in neonate.
Methods
: This study was performed on 2234 neonates born at Pusan Moon Hwa Hospital from November 1991 to December 1993. These 2234 neonates were injected intramuscularly hepatitis B virus vaccine and evaluated antibody titer within 3 months after completion of vaccination. We used heat inactivated plasma-derived HBV vaccine (H-vaccine), formalin inactivated plasma-derived HBV vaccine (F-vaccine), and recom¡ⓒ binant HBV vaccine (R-vaccine). The vaccination was done at 0,1, and 2 month of age (2 month schedule) or 0,1, and 6 month of age (6 month schedule). All tests used an enzyme immunoassay (IMx AUSAB, Abbott Laboratories). An anti¡ⓒ HBs level that would confer protection against HBV infection was defined as a level equal to or greater than lOmlu/ml.
Results
: 1) The seroconversion rate was 99.6% using R-vaccine with 6 month schedule, 91.3% using F-vaccine with 6 month schedule, and 78.1% using H-vaccine with 2 month schedule. There were statstical difference among H-vaccine, F-vaccine, and R-vaccine (p<0.01) 2) The seroconversion rate of 2 month schedule was 98.6% with R-vaccine, 85.1% with F-vaccine, 78.1% with H-vaccine. There were statistical difference among H¡ⓒ vaccine, F-vaccine, and R-vaccine (p<0.01) 3) The geometric mean titers of R-vaccine with 6 month schedule was highest among vaccination schedules (p<0.01) 4) The seroconversion rate of 6 month schedule was significantly higher than that of 2 month schedule (p<0.01)
Conclusion
: In this study, the immunogenicity of the recombinant HBV vaccine was better than that of the plasma-derived HBV vaccine, and the seroconversion rate of 6 month schedule was significantly higher than that of 2 month schedule. So, we thought that the recombinant HBV vaccine should replace the plasma-derived HBV vaccine.
Key Words: Plasma-derived HBV vaccine, Recombinant HBV vaccine


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