title: Immunogenicity and safety of human papillomavirus-16/18 AS04-adjuvanted cervical cancer vaccine coadministered with combined diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine to girls and young women.
abstract: OBJECTIVE
  Many countries recommend human papillomavirus (HPV) vaccination in female adolescents at an age when other vaccines are routinely administered. This open, randomized, multicenter study (108464/NCT00426361) evaluated coadministration of HPV-16/18 AS04-adjuvanted vaccine with diphtheria-tetanus-acellular pertussis-inactivated poliovirus vaccine (dTpa-IPV).
  
  
  METHODS
  Healthy females aged 10-18 years were randomized to receive HPV vaccine at months 0, 1, and 6 (n = 248), HPV vaccine coadministered with dTpa-IPV at month 0 and HPV vaccine at months 1 and 6 (n = 255), or dTpa-IPV at month 0 followed by HPV vaccine at months 1, 2, and 7 (n = 248). Immunogenicity was evaluated at months 0, 1, and 7 or 8 (depending on group). Vaccine reactogenicity and safety were also assessed.
  
  
  RESULTS
  Coadministered dTpa-IPV and HPV vaccine was noninferior to dTpa-IPV alone in terms of seroprotection against diphtheria (99.2% and 100%), tetanus (100% and 100%) and poliovirus types 1, 2, and 3 (> or = 99.6%), and geometric mean antibody concentrations (ELISA Units/mL) for pertussis toxoid (84 vs. 75), filamentous hemagglutinin (612 and 615) and pertactin (426 and 360) at month 1. Coadministered dTpa-IPV and HPV vaccine was noninferior to HPV vaccine alone in terms of seroconversion rates for HPV-16 (99.5% and 100%) and HPV-18 (99.5% and 100%) and geometric mean antibody titers (ELISA Units/mL) for HPV-16 (15,608 and 18,965) and HPV-18 (6,597 and 6,902) at month 7. Coadministration was generally well tolerated. The reactogenicity of dTpa-IPV and the first dose of HPV vaccine was similar.
  
  
  CONCLUSIONS
  Results from this study support coadministration of the HPV-16/18 AS04-adjuvanted vaccine with dTpa-IPV vaccine in females aged 10-18 years.
authors.affiliation: Hospital Infantil Universitario La Paz, Madrid, Spain. jgarcia-sicilia@telefonica.net
authors.forename: José
authors.initials: J
authors.lastname: Garcia-Sicilia
authors.forename: Tino F
authors.initials: TF
authors.lastname: Schwarz
authors.forename: Alfonso
authors.initials: A
authors.lastname: Carmona
authors.forename: Klaus
authors.initials: K
authors.lastname: Peters
authors.forename: Jean-Elie
authors.initials: JE
authors.lastname: Malkin
authors.forename: Phu M
authors.initials: PM
authors.lastname: Tran
authors.forename: Ulrich
authors.initials: U
authors.lastname: Behre
authors.forename: Enrique B
authors.initials: EB
authors.lastname: Iturbe
authors.forename: Gregory
authors.initials: G
authors.lastname: Catteau
authors.forename: Florence
authors.initials: F
authors.lastname: Thomas
authors.forename: Kurt
authors.initials: K
authors.lastname: Dobbelaere
authors.forename: Dominique
authors.initials: D
authors.lastname: Descamps
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D000276:Adjuvants, Immunologic / Q000008:administration & dosage; D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D015721:Diphtheria-Tetanus-Pertussis Vaccine / Q000008:administration & dosage* / Q000276:immunology; D004305:Dose-Response Relationship, Drug; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000276:immunology; D011054:Poliovirus Vaccine, Inactivated / Q000008:administration & dosage* / Q000276:immunology; D013997:Time Factors; D002583:Uterine Cervical Neoplasms / Q000276:immunology / Q000517:prevention & control*; D017778:Vaccines, Combined / Q000008:administration & dosage
chemical_list: D000276:Adjuvants, Immunologic; D000914:Antibodies, Viral; D015721:Diphtheria-Tetanus-Pertussis Vaccine; D053918:Papillomavirus Vaccines; D011054:Poliovirus Vaccine, Inactivated; D017778:Vaccines, Combined; C510352:human papillomavirus vaccine, L1 type 16, 18