Korean J Infect Dis.  1998 Feb;30(1):69-74.

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

Affiliations
  • 1Department of Pediatrics, College of Medicine, Hallym University, Kangwondo, Korea.
  • 2Department of Microbiology, College of Medicine, Hallym University, Kangwondo, Korea.
  • 3Department of Internal Medicine, College of Medicine, Hallym University, Kangwondo, Korea.
  • 4Department of Clinical Pathololgy, College of Medicine, Hallym University, Kangwondo, Korea.

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.

Keyword

Hepatitis B vaccine; Recombinant; Immunogenecity; Safety

MeSH Terms

Adult
Appointments and Schedules
Child
Enzyme-Linked Immunosorbent Assay
Hepatitis B Vaccines
Hepatitis B*
Hepatitis*
Humans
Immunization
Immunization Schedule
Korea
Vaccination
Hepatitis B Vaccines
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