Safety and immunogenicity of a recombinant hepatitis B vaccine administered to infants at 2, 4 and 6 months of age. The Kaiser-UCLA Vaccine Study Group.

Abstract

A recombinant hepatitis B vaccine was administered to over 5000 infants in a prospective, randomized and blinded study. Infants were given either recombinant hepatitis B vaccine (Engerix-B, SmithKline Beecham Pharmaceuticals, 10 micrograms dose-1) or a Haemophilus influenzae type b (Hib) conjugate vaccine at 2, 4 and 6 months of age simultaneously with diphtheria-tetanus-pertussis and oral polio vaccines. Adverse reactions were ascertained by parental reports and interviews, and review of medical records. Blood specimens collected from 269 infants given hepatitis B vaccine were assayed for antibody to hepatitis B surface antigen (anti-HBs) by enzyme immunoassay. Infants given hepatitis B vaccine experienced low rates of adverse reactions that were similar or lower than the rates in infants given Hib conjugate vaccine. The geometric mean anti-HBs concentrations were 9.6 mIU ml-1 after one dose, 333 mIU ml-1 after two doses and 1812 mIU ml-1 after three doses (99% had levels > or = 10 mIU ml-1). Antibody responses to diphtheria and tetanus toxoids were unaffected by simultaneous administration of hepatitis B or Hib conjugate vaccine. Engerix-B vaccine was safe and immunogenic when given with other routine childhood immunizations at 2, 4 and 6 months of age, and should provide long-term protection against hepatitis B virus infection.

• Authors: D P Greenberg, C M Vadheim, S M Marcy, S Partridge, J Jing, C Y Chiu, T Greene, H S Margolis, J I Ward
• Journal: Vaccine (Vaccine) Vol. 14 Issue 8 Pg. 811-6 (Jun 1996) ISSN: 0264-410X [Print] Netherlands
• PMID: 8817829 (Publication Type: Clinical Trial, Journal Article, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Antibodies, Bacterial
• Bacterial Vaccines
• Diphtheria-Tetanus-Pertussis Vaccine
• Hepatitis B Antibodies
• Hepatitis B Vaccines
• Poliovirus Vaccine, Inactivated
• Vaccines, Synthetic

Topics

• Antibodies, Bacterial (biosynthesis)
• Bacterial Vaccines (administration & dosage)
• Diphtheria-Tetanus-Pertussis Vaccine (administration & dosage)
• Hepatitis B Antibodies (biosynthesis)
• Hepatitis B Vaccines (administration & dosage, adverse effects, immunology)
• Humans
• Infant
• Poliovirus Vaccine, Inactivated (administration & dosage)
• Prospective Studies
• Vaccines, Synthetic (administration & dosage, adverse effects, immunology)