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Original Articles
Immunogenicity and Safety of Recombinant Hepatitis B Vaccine(Engerix B)
Kyung Ja Lee, M.D.1, Min Kee Cho, Ph.D.2, Woong Ki Chang, M.D.3, Hae Sun Yoon, M.D.1 Jae Kook Cha, M.D.1, Jeong Eun Choi, M.D.3, Chong Young Park, M.D.1, Sang Aun Joo, M.D.3 and Hee Jung Kang, M.D.4
Departmetn of Pediatrics1, Microbiology2, Internal Medicine3 and Clinical Pathololgy4, College of Medicine, Hallym University, Kangwondo, Korea
Vol.30 Num.1 (p69~74)
Background:Several studies on the efficacy and safety of the hepatitis B vaccine have shown variable immunogenicity. In this study we reexamined the immunogenicity and safety of recombinant hepatitis B vaccine, Engerix B which have currently been administered to the children in Korea.
Methods:Serum samples were collected from 126 children and 111 adults who were immunized according to the 0, 1, 2-month and 0, 1, 6-month vaccination schedule. Anti-HBs antibody titers were measured by ELISA in sera obtained after each immunization, and compared by immunization schedules.
Results:In 62 children with 0, 1, 2-month immunization schedule seroconversion rate was 83.9% after 1st vaccination, 96.8% after 2nd, and 98.4% after 3rd. In 64 children with 0, 1, 6-month immunization schedule seroconversion rates was 78.1% after 1st vaccination, 87.5% after 2nd and 100% after 3rd. In 50 adults immunized with 0, 1, 2-month schedule seroconversion rates was 48.0% after 1st vaccination, 74.0% after 2nd and 90.0% after 3rd. In 61 adults immunized with 0, 1, 6-month schedule seroconversion rate was 44.3% after 1st vaccination, 65.6% after 2nd and 93.4% after 3rd. Seroconversion rate after 0, 1, 2- month vaccination schedule were 98.4% in children and 90.0% in adults. Seroconversion rate after 0, 1, 6-month schedule were 100% in children and 93.4% in adults. There were no significant local and systemic untoward reactions among vaccinees.
Conclusion:The recombinant Engerix B is excellent in immunogenicity with 93.4% and 100% seroconversion rates in adults and children, respectively. There is no significant difference in seroconversion rate between two vaccination schedule. The vaccine is safe.
Keywords : Hepatitis B vaccine, Recombinant, Immunogenecity, Safety