title: Immunogenicity and safety of 3-dose primary vaccination with combined DTPa-HBV-IPV/Hib vaccine in Canadian Aboriginal and non-Aboriginal infants.
abstract: This study compared immune responses of healthy Aboriginal and non-Aboriginal infants to Haemophilus influenzae type b (Hib) and hepatitis B virus (HBV) components of a DTaP-HBV-IPV/Hib combination vaccine, 1 month after completing dosing at 2, 4 and 6 months of age. Of 112 infants enrolled in each group, 94 Aboriginal and 107 non-Aboriginal infants qualified for the immunogenicity analysis. Anti-PRP concentrations exceeded the protective minimum (≥0.15 μg/ml) in ≥97% of infants in both groups but geometric mean concentrations (GMCs) were higher in Aboriginal infants (6.12 μg/ml versus 3.51 μg/ml). All subjects were seroprotected (anti-HBs ≥10 mIU/mL) against HBV, with groups having similar GMCs (1797.9 versus 1544.4 mIU/mL, Aboriginal versus non-Aboriginal, respectively). No safety concerns were identified. We conclude that 3-dose primary vaccination with DTaP-HBV-IPV/Hib combination vaccine elicited immune responses to Hib and HBV components that were at least as high in Aboriginal as in non-Aboriginal Canadian infants. Clinical Trial Registration NCT00753649.
authors.affiliation: Vaccine Evaluation Center, BC Children's Hospital, Canada; University of British Columbia, Vancouver, Canada. Electronic address: dscheifele@cfri.ca.
authors.forename: David W
authors.initials: DW
authors.lastname: Scheifele
authors.affiliation: Colchester Research Group, Truro, NS, Canada.
authors.forename: Murdo
authors.initials: M
authors.lastname: Ferguson
authors.affiliation: Alberta Health, Edmonton, Alta., Canada.
authors.forename: Gerald
authors.initials: G
authors.lastname: Predy
authors.affiliation: Vaccine Evaluation Center, BC Children's Hospital, Canada; University of British Columbia, Vancouver, Canada.
authors.forename: Meena
authors.initials: M
authors.lastname: Dawar
authors.affiliation: GlaxoSmithKline Vaccines, Bangalore, India.
authors.forename: Deepak
authors.initials: D
authors.lastname: Assudani
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: Sherine
authors.initials: S
authors.lastname: Kuriyakose
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium.
authors.forename: Olivier
authors.initials: O
authors.lastname: Van Der Meeren
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, PA, USA.
authors.forename: Htay-Htay
authors.initials: HH
authors.lastname: Han
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood / Q000276:immunology; D002170:Canada / Q000453:epidemiology / Q000208:ethnology; D003140:Communicable Disease Control / Q000379:methods / Q000706:statistics & numerical data*; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D005260:Female; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006510:Hepatitis B Antibodies / Q000097:blood / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D006801:Humans; D007223:Infant; D008297:Male; D062486:Public Health Surveillance; D014611:Vaccination
chemical_list: D000907:Antibodies, Bacterial; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; D006510:Hepatitis B Antibodies; D017325:Hepatitis B Vaccines; C122182:diphtheria-tetanus-acellular pertussis-Hib-hepatitis B vaccine
keywords: Aboriginal; Combination vaccine; Haemophilus influenzae b; Hepatitis B; Immunogenicity; Safety