title: Immunogenicity and reactogenicity of a decennial booster dose of a combined reduced-antigen-content diphtheria-tetanus-acellular pertussis and inactivated poliovirus booster vaccine (dTpa-IPV) in healthy adults.
abstract: BACKGROUND
  Pertussis in adults and adolescents could be reduced by replacing traditional tetanus and diphtheria (Td) boosters with reduced-antigen-content diphtheria-tetanus-acellular pertussis (dTpa) vaccines. This study evaluated the administration of dTpa-IPV (dTpa-inactivated poliovirus) in adults ten years after they received a booster dose of either dTpa-IPV, dTpa+IPV or Td-IPV in trial NCT01277705.
  
  
  METHODS
  Open multicentre, phase IV study (www.clinicaltrials.govNCT01323959) in which healthy adults, who had received a previous dose of dTpa-IPV, dTpa+IPV or Td-IPV ten years earlier, received a single decennial booster dose of dTpa-IPV (Boostrix-polio, GlaxoSmithKline Vaccines). Blood samples were collected before and one month after booster vaccination. Antibody concentrations against all vaccine antigens were measured and reactogenicity and safety were assessed.
  
  
  RESULTS
  A total of 211 subjects (mean age 50.3 years) received vaccination of whom 201 were included in the according-to-protocol cohort for immunogenicity. Before the decennial dTpa-IPV booster, ≥71.0% subjects were seroprotected/seropositive against all vaccine antigens. One month after the booster dose, all subjects were seroprotected against tetanus and poliovirus types 2 and 3; ≥95.7% subjects were seroprotected against diphtheria and ≥98.3% against poliovirus type 1. Anti-pertussis booster responses for the various antigens were observed in ≥76.5% (pertussis toxoid; PT), ≥85.1% (filamentous haemagglutinin; FHA) and ≥63.2% (pertactin; PRN) of subjects. During the 4-day follow-up, the overall incidence of local AEs was 71.6%, 75.0% and 72.2% in dTpa-IPV, dTpa+IPV and Td-IPV groups, respectively. Pain was the most frequent solicited local adverse event (AE; ≥62.7% subjects) and fatigue the most frequent solicited general AE (≥18.5%). No serious AEs were reported during the study.
  
  
  CONCLUSIONS
  A booster dose of dTpa-IPV was immunogenic and well tolerated in adults who had received a booster dose of either dTpa-IPV, dTpa+IPV or Td-IPV, ten years previously and supports the repeated administration of dTpa-IPV.
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Martina
authors.initials: M
authors.lastname: Kovac
authors.affiliation: GSK Vaccines, Bangalore, India.
authors.forename: Niraj
authors.initials: N
authors.lastname: Rathi
authors.affiliation: GSK Vaccines, Bangalore, India.
authors.forename: Sherine
authors.initials: S
authors.lastname: Kuriyakose
authors.affiliation: GSK Vaccines, Wavre, Belgium.
authors.forename: Karin
authors.initials: K
authors.lastname: Hardt
authors.affiliation: Central Laboratory and Vaccination Centre, Stiftung Juliusspital, Würzburg, Germany. Electronic address: t.schwarz@juliusspital.de.
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
mesh_terms: D000328:Adult; D000907:Antibodies, Bacterial / Q000097:blood; D000914:Antibodies, Viral / Q000097:blood; D004167:Diphtheria Toxin / Q000276:immunology; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines / Q000008:administration & dosage* / Q000009:adverse effects / Q000276:immunology*; D005260:Female; D005500:Follow-Up Studies; D005602:France; D005858:Germany; D064368:Healthy Volunteers; D006801:Humans; D007117:Immunization, Secondary; D007273:Injections, Intramuscular; D008297:Male; D008875:Middle Aged; D017955:Poliovirus / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D013744:Tetanus Toxin; D013997:Time Factors; D017778:Vaccines, Combined / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D000907:Antibodies, Bacterial; D000914:Antibodies, Viral; C505143:Boostrix; D004167:Diphtheria Toxin; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D022681:Diphtheria-Tetanus-acellular Pertussis Vaccines; D011054:Poliovirus Vaccine, Inactivated; D013744:Tetanus Toxin; D017778:Vaccines, Combined
keywords: Adults; Decennial booster; Diphtheria; Pertussis; Poliomyelitis; Tetanus; dTpa–IPV