Long-term efficacy of recombinant hepatitis B vaccine and risk of natural infection in infants born to mothers with hepatitis B e antigen

J Pediatr. 1995 May;126(5 Pt 1):716-21. doi: 10.1016/s0022-3476(95)70398-5.


To evaluate the long-term protection afforded by the vaccine, recombinant hepatitis B (HB) vaccine was given to 171 infants born to hepatitis B e antigen-positive carrier mothers. Group A (53 infants) and group B (57 infants) received four doses of HB vaccine at birth and at 1, 2, and 12 months of age, with a dose of 20 micrograms in group A and 10 micrograms in group B. Group C (61 infants) received three 20 micrograms doses of HB vaccine at birth and at 1 and 6 months of age. These children were followed up annually up to 5 years of age. Six children (4%) became HB carriers before 1 year of age, and the carrier state persisted to the end of follow-up. The overall seropositive rate of HB surface antibody (anti-HBs) dropped from 99% at 1 year of age to 83% at 5 years of age. Among 548 serum pairs taken at 1-year intervals from children negative for HB surface antigen (HBsAg), a fourfold rise of anti-HBs titer was noted in 58 (11%) and a 10-fold rise of anti-HBs was noted in 17 (3%). Maternal HB core antibody disappeared in most children (151/152, 99%) before 2 years of age. Natural infections, as judged by persistence or reappearance of HB core antibody, occurred in 19 of 163 (12%) HBsAg-negative children. None of these episodes was associated with HBsAg positivity. We conclude that the long-term protection afforded by recombinant HB vaccine is satisfactory and that a further booster dose before 5 years of age is not necessary.

Publication types

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

MeSH terms

  • Biomarkers / blood
  • Carrier State
  • Child, Preschool
  • Female
  • Follow-Up Studies
  • Hepatitis B / blood
  • Hepatitis B / immunology
  • Hepatitis B / prevention & control*
  • Hepatitis B / transmission
  • Hepatitis B Antibodies / blood
  • Hepatitis B Surface Antigens / blood
  • Hepatitis B Vaccines*
  • Hepatitis B e Antigens / blood
  • Humans
  • Immunity, Innate
  • Immunization Schedule
  • Immunization, Secondary
  • Infant
  • Infant, Newborn
  • Infectious Disease Transmission, Vertical*
  • Mothers
  • Regression Analysis
  • Risk Factors
  • Time Factors
  • Vaccines, Synthetic*


  • Biomarkers
  • Engerix-B
  • Hepatitis B Antibodies
  • Hepatitis B Surface Antigens
  • Hepatitis B Vaccines
  • Hepatitis B e Antigens
  • Vaccines, Synthetic