Immunogenicity and Safety of Recombinant Hepatitis B Vaccine(Engerix B) / 감염

ABSTRACT

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 seroconversionrates 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.