Impact of a birth dose of hepatitis B vaccine on the reactogenicity

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Pediatr Infect Dis J 2002 Sep;21(9):854-859



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.

Pichichero ME, Blatter MM, Reisinger KS, Harrison CJ, Johnson CE, Steinhoff
MC, Senders SD, Rothstein EP, Willems P, Howe BJ
[Record supplied by publisher]


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)/ type b (Hib) combination vaccine administered subsequently at 2, 4
and 6 months of age.METHODS Neonates ( = 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.

PMID: 12352809