Impact of a birth dose of hepatitis B vaccine on the reactogenicity and immunogenicity of diphtheria-tetanus-acellular pertussis-hepatitis B-inactivated poliovirus-Haemophilus influenzae type b combination vaccination

Michael E. Pichichero, Mark M. Blatter, Keith S. Reisinger, Christopher J. Harrison, Candice E. Johnson, Mark C. Steinhoff, Shelly D. Senders, Edward P. Rothstein, Paul Willems, Barbara J. Howe

Research output: Contribution to journalArticle

Abstract

Objectives. To assess the impact of a birth dose of hepatitis B vaccine (HepB) on the reactogenicity and immunogenicity of a novel diphtheria-tetanus-acellular pertussis (DTaP)-HepB-inactivated poliovirus (IPV)/Haemophilus influenzae type b (Hib) combination vaccine administered subsequently at 2, 4 and 6 months of age. Methods. Neonates (n = 550) were randomized into two groups with regard to receipt of HepB at birth. All subjects in both groups received DTaP-HepB-IPV/Hib at 2, 4 and 6 months of age. Solicited local and general adverse events were recorded for 8 days after each dose. Antibodies to hepatitis B surface antigen were measured 1 month after the third dose of DTaP-HepB-IPV/ Hib in a subset of 170 infants; titers of at least 10 mIU/ml were considered protective. Results. The DTaP-HepB-IPV/Hib combination vaccine was well-tolerated in both groups. Of the infants who received a birth dose of HepB, 22.6% had severe (Grade 3) reactions after any of the three doses of DTaP-HepB-IPV/Hib combination vaccine compared with 23.2% of subjects who did not receive a birth dose of HepB (difference, -0.5%; 90% confidence interval, -7.4 to 6.1). Antibody to hepatitis B surface antigen titers were ≪10 mIU/ml for all tested infants. Geometric mean titers were 2996.2 and 1240.1 mIU/ml with and without a birth dose of HepB, respectively. Conclusions. A HepB birth dose does not increase the reactogenicity of a combination DTaP-HepB-IPV/Hib vaccine administered at 2, 4 and 6 months of age, and all tested subjects achieved protective anti-HBs titers (≥10 mIU/ml), although geometric mean titers were higher when a birth dose of HepB was given.

Original languageEnglish (US)
Pages (from-to)854-859
Number of pages6
JournalPediatric Infectious Disease Journal
Volume21
Issue number9
DOIs
StatePublished - Oct 5 2002

Keywords

  • Diphtheria-tetanus-pertussis vaccine
  • Haemophilus influenzae type b vaccine
  • Hepatitis B vaccine
  • Immunogenicity
  • Inactivated poliovirus vaccine
  • Infant vaccination

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Microbiology (medical)
  • Infectious Diseases

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