title: Antibody persistence and booster vaccination of a fully liquid hexavalent vaccine coadministered with measles/mumps/rubella and varicella vaccines at 15-18 months of age in healthy South African infants.
abstract: OBJECTIVE
  To assess antibody persistence and booster immunogenicity and safety of a new, fully liquid, hexavalent DTaP-IPV-Hep B-PRP-T vaccine.
  
  
  METHODS
  Phase III, open-label, 2-center trial. Infants previously primed at 6, 10, 14 weeks of age with DTaP-IPV-Hep B-PRP-T either without (group 1: N = 218) or with hepatitis B at birth (group 3: N = 130) or control DTwP-Hib, hepatitis B and oral poliovirus vaccine vaccines (group 2: N = 219) received the same vaccine(s) as booster (except hepatitis B for group 2) at 15-18 months of age, coadministered with measles/mumps/rubella and varicella vaccines (MMR+V). All participants had received measles vaccine at 9 months of age. Antibodies were measured prebooster and 1 month postbooster vaccination. Safety was evaluated from parental reports. Analyses were descriptive.
  
  
  RESULTS
  Antibody persistence (seroprotection and concentration) at 15-18 months of age was high for each valence and similar in each group, except for Hep B (highest in group 3 [extra dose of hepatitis B]) and PRP (highest in group 2). Postbooster seroprotection (D, T, IPV, Hep B, PRP) and seroconversion (pertussis toxin and filamentous hemagglutinin) rates were high and similar in each group (excluding Hep B in group 2 [no booster]); geometric mean antibody levels increased markedly in all groups. The response to MMR+V was similar in each group. All vaccines were well tolerated.
  
  
  CONCLUSIONS
  A booster dose of the new DTaP-IPV-Hep B-PRP-T vaccine at 15-18 months of age is highly immunogenic and safe compared with licensed comparators, following primary series administration in the Expanded Program on Immunization schedule, with or without a hepatitis B vaccine at birth and coadministered with MMR+V.
authors.affiliation: Department of Science, University of the Witwatersrand, Faculty of Health Science, National Research Foundation: Vaccine Preventable Diseases, Johannesburg, South Africa.
authors.forename: Shabir A
authors.initials: SA
authors.lastname: Madhi
authors.forename: Anthonet
authors.initials: A
authors.lastname: Koen
authors.forename: Clare
authors.initials: C
authors.lastname: Cutland
authors.forename: Michelle
authors.initials: M
authors.lastname: Groome
authors.forename: Eduardo
authors.initials: E
authors.lastname: Santos-Lima
mesh_terms: D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D019433:Chickenpox Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D018073:Haemophilus Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D017325:Hepatitis B Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D006801:Humans; D007115:Immunization Schedule; D007117:Immunization, Secondary; D007223:Infant; D022542:Measles-Mumps-Rubella Vaccine / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology; D013019:South Africa; D013745:Tetanus Toxoid / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; D019433:Chickenpox Vaccine; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D018073:Haemophilus Vaccines; C055753:Haemophilus influenza type b polysaccharide vaccine-tetanus toxin conjugate; D017325:Hepatitis B Vaccines; D022542:Measles-Mumps-Rubella Vaccine; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D017778:Vaccines, Combined