title: Adult formulation of a five component acellular pertussis vaccine combined with diphtheria and tetanus toxoids and inactivated poliovirus vaccine is safe and immunogenic in adolescents and adults.
abstract: BACKGROUND
  Pertussis is increasingly recognized as an important cause of cough illness in adolescents and adults.
  
  
  OBJECTIVE
  To evaluate the safety and antibody response to a single dose of an adult formulation of a five component (pertussis toxoid, filamentous hemagglutinin, pertactin, fimbriae 2 and 3) acellular pertussis vaccine (aP) combined with diphtheria and tetanus toxoids (TdaP) and inactivated poliovirus vaccine (TdaP-IPV) in adolescents and adults and to assess the response to a second dose of the acellular pertussis vaccine in a subset of the adults.
  
  
  METHODS
  The study addressed 1207 healthy participants (736 adults and 466 adolescents) recruited in five Canadian communities.
  
  
  METHODS
  In a randomized, observer-blind, controlled clinical trial, adult participants received Td followed at a separate visit by aP, TdaP followed by IPV or TdaP-IPV; adolescents received Td-IPV followed at a separate visit by aP or TdaP-IPV. A subgroup of adults was given a booster of aP 1 month after TdaP.
  
  
  METHODS
  Antibody titers measured before and 1 month after each immunization; adverse events enumerated at 24 h, 72 h and 8 to 10 days.
  
  
  RESULTS
  The aP vaccine given by itself was associated with adverse events less frequently than were Td, Td-IPV, TdaP or TdaP-IPV vaccines, but reaction rates did not differ significantly among the latter products. The antibody response against Bordetella pertussis antigens was vigorous in all groups, although adults given the TdaP-IPV vaccine had lower antibody titers against filamentous hemagglutinin, pertactin, diphtheria and tetanus antibodies than those given TdaP vaccine. Similarly adolescents given TdaP-IPV had lower antibody titers against pertussis toxin, filamentous hemagglutinin, fimbriae and agglutinins than those given Td-IPV and aP alone. A second dose of acellular pertussis vaccine was not associated with increased adverse events in adults but elicited increased antibody titers over that achieved by a single dose only against pertussis toxin.
  
  
  CONCLUSIONS
  This adult formulation five component aP vaccine given as TdaP-IPV is safe and immunogenic in adolescents and adults and is a candidate vaccine for adolescent and adult immunization programs.
authors.affiliation: Department of Pediatrics, Dalhousie University and the IWK Grace Health Centre, Halifax, Nova Scotia, Canada. shalperin@iwkgrace.ns.ca
authors.forename: S A
authors.initials: SA
authors.lastname: Halperin
authors.forename: B
authors.initials: B
authors.lastname: Smith
authors.forename: M
authors.initials: M
authors.lastname: Russell
authors.forename: D
authors.initials: D
authors.lastname: Scheifele
authors.forename: E
authors.initials: E
authors.lastname: Mills
authors.forename: P
authors.initials: P
authors.lastname: Hasselback
authors.forename: C
authors.initials: C
authors.lastname: Pim
authors.forename: W
authors.initials: W
authors.lastname: Meekison
authors.forename: R
authors.initials: R
authors.lastname: Parker
authors.forename: P
authors.initials: P
authors.lastname: Lavigne
authors.forename: L
authors.initials: L
authors.lastname: Barreto
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000917:Antibody Formation / Q000276:immunology; D002626:Chemistry, Pharmaceutical; D002648:Child; D016001:Confidence Intervals; D004168:Diphtheria Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D004305:Dose-Response Relationship, Drug; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D012680:Sensitivity and Specificity; D013745:Tetanus Toxoid / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014121:Toxoids / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology*; D014611:Vaccination / Q000379:methods; D017778:Vaccines, Combined / Q000009:adverse effects / Q000276:immunology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology
chemical_list: D004168:Diphtheria Toxoid; D011054:Poliovirus Vaccine, Inactivated; D013745:Tetanus Toxoid; D014121:Toxoids; D017778:Vaccines, Combined; D015164:Vaccines, Inactivated; C051093:pertussis toxoid