SAFETY AND IMMUNOGENICITY OF A RECOMBINANT HEPATITIS-B VACCINE ADMINISTERED TO INFANTS AT 2, 4 AND 6 MONTHS OF AGE

A recombinant hepatitis B vaccine was administered to over 5000 infant s in a prospective, randomized and blinded study. Infants were given e ither recombinant hepatitis B vaccine (Engerix-B(R), SmithKline Beecha m Pharmaceuticals, 10 mu g dose(-1)) or a Haemophilus influenzae type b (Hib) conjugate vaccine at 2, 4 and 6 months of age simultaneously w ith diphtheria-tetanus-pertussis and oral polio vaccines. Adverse reac tions were ascertained by parental reports and interviews, and review of medical records. Blood specimens collected from 269 infants given h epatitis B vaccine were assayed for antibody to hepatitis B surface an tigen (anti-HBs) by enzyme immunoassay. Infants given hepatitis B vacc ine experienced low rates of adverse reactions that were similar or lo wer than the rates in infants given Hib conjugate vaccine. The geometr ic mean anti-HBs concentrations were 9.6 mlU ml(-1) after one dose, 33 3 mIU ml(-1) after two doses and 1812 mIU ml(-1) after three doses (99 % had levels greater than or equal to 10 mIU ml(-1)). Antibody respons es to diphtheria and tetanus toxoids were unaffected by simultaneous a dministration of hepatitis B or Hib conjugate vaccine. Engerix-B vacci ne,was safe and immunogenic when given with other routine childhood im munizations at 2, 4 and 6 months of age, and should pro vide long-term protection against hepatitis B virus infection. Copyright (C) 1996 El sevier Science Ltd.