Immunogenicity of 10 and 20 microgram hepatitis B vaccine in a two-dose schedule

Vaccine. 2003 Jul 4;21(23):3179-85. doi: 10.1016/s0264-410x(03)00232-9.

Abstract

Healthy subjects (15-50 years old) were randomised to receive, intramuscularly, 10 or 20 micrograms of a yeast-derived recombinant hepatitis B vaccine (Heberbiovac HB) on a two-dose (0-1) schedule. Anti-hepatitis B surface antigen antibodies (HBsAb) were determined at 2, 3 and 6 months. Twenty micrograms immunisation yielded 96.3% seroprotection (HBsAb >10 IU/l) at t=3, which persisted to 97.2% at t=6. The 10 microgram group resulted in 87.4% seroprotection at t=3 and 81% at t=6, but reached >95% among subjects <21 years old, both at t=3 and 6. It is concluded that the vaccine used is highly immunogenic and the two-dose 20 microgram immunisation can be used in all age groups and 10 micrograms in subjects up to 20 years. These schedules can result in significantly better compliance and cost-effectiveness of the vaccination programs.

Publication types

  • Clinical Trial
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aging / immunology
  • Dose-Response Relationship, Immunologic
  • Double-Blind Method
  • Female
  • Hepatitis B Antibodies / analysis
  • Hepatitis B Antibodies / biosynthesis
  • Hepatitis B Surface Antigens / analysis
  • Hepatitis B Surface Antigens / immunology
  • Hepatitis B Vaccines / administration & dosage
  • Hepatitis B Vaccines / immunology*
  • Humans
  • Immunization Schedule
  • Male
  • Middle Aged
  • Obesity / immunology
  • Prospective Studies
  • Vaccines, Synthetic / immunology

Substances

  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Vaccines, Synthetic