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.
OBJECTIVE
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 > or =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 (> or =10 mIU/ml), although geometric mean titers were higher when a birth dose of HepB was given.
D016667:Bacterial Capsules; D015331:Cohort Studies; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000009:adverse effects / Q000276:immunology*; D004334:Drug Administration Schedule; D018073:Haemophilus Vaccines / Q000009:adverse effects / Q000276:immunology*; D006509:Hepatitis B / Q000517:prevention & control; D006514:Hepatitis B Surface Antigens / Q000097:blood; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007231:Infant, Newborn; D011054:Poliovirus Vaccine, Inactivated / Q000009:adverse effects / Q000276:immunology*; D011135:Polysaccharides, Bacterial / Q000009:adverse effects / Q000276:immunology*; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology*
D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D018073:Haemophilus Vaccines; C044237:Haemophilus influenzae type b polysaccharide vaccine; D006514:Hepatitis B Surface Antigens; D017325:Hepatitis B Vaccines; D011054:Poliovirus Vaccine, Inactivated; D011135:Polysaccharides, Bacterial; D017778:Vaccines, Combined