title: 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.affiliation: UCLA Center for Vaccine Research, Harbor-UCLA Medical Center, Torrance 90502, USA.
authors.forename: D P
authors.initials: DP
authors.lastname: Greenberg
authors.forename: C M
authors.initials: CM
authors.lastname: Vadheim
authors.forename: S M
authors.initials: SM
authors.lastname: Marcy
authors.forename: S
authors.initials: S
authors.lastname: Partridge
authors.forename: J
authors.initials: J
authors.lastname: Jing
authors.forename: C Y
authors.initials: CY
authors.lastname: Chiu
authors.forename: T
authors.initials: T
authors.lastname: Greene
authors.forename: H S
authors.initials: HS
authors.lastname: Margolis
authors.forename: J I
authors.initials: JI
authors.lastname: Ward
mesh_terms: D000907:Antibodies, Bacterial / Q000096:biosynthesis; D001428:Bacterial Vaccines / Q000008:administration & dosage; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage; D006510:Hepatitis B Antibodies / Q000096:biosynthesis; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007223:Infant; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage; D011446:Prospective Studies; D014614:Vaccines, Synthetic / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D001428:Bacterial Vaccines; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D014614:Vaccines, Synthetic