title: The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24.
abstract: BACKGROUND
  Quadrivalent human papillomavirus (HPV types 6/11/16/18) L1 VLP vaccine is highly effective in preventing HPV 6/11/16/18-related cervical and external genital disease. Herein, we evaluated the impact of the quadrivalent HPV 6/11/16/18 L1 VLP vaccine on prevention of HPV-associated cervico-genital lesions in a broad population of sexually active European women.
  
  
  METHODS
  Female subjects (N = 9265) aged 16-24 with four or fewer lifetime sexual partners were enrolled and randomized to quadrivalent HPV vaccine or placebo. Subjects underwent cervicovaginal sampling for HPV DNA detection. Papanicolaou testing and anti-HPV 6/11/16/18 serology testing was also performed.
  
  
  RESULTS
  Vaccine efficacy against lesions representing immediate cervical cancer precursors (cervical intraepithelial neoplasia grade 2/3 or adenocarcinoma in situ) related to HPV 6/11/16/18 in the per-protocol population was 100.0%[95% confidence interval (95% CI), 89.8-100.0]. Efficacy against external genital lesions (vulvar or vaginal intraepithelial neoplasia, condyloma, vulvar or vaginal cancer) related to vaccine HPV types in the per-protocol European population was 99.0% (95% CI, 94.4-100.0).
  
  
  CONCLUSIONS
  These data demonstrate that quadrivalent HPV 6/11/16/18 vaccination programs in 16- to 24-year-old European women can be beneficial. NCT0009252, NCT00092534, NCT00092495.
authors.affiliation: Department of Dermatology and Venereology, Center of Diagnostics and Treatment of Sexually Transmitted Diseases, Medical University of Warsaw, Warsaw, Poland. smajewski@kl.amwaw.edu.pl
authors.forename: S
authors.initials: S
authors.lastname: Majewski
authors.forename: F X
authors.initials: FX
authors.lastname: Bosch
authors.forename: J
authors.initials: J
authors.lastname: Dillner
authors.forename: O-E
authors.initials: OE
authors.lastname: Iversen
authors.forename: S K
authors.initials: SK
authors.lastname: Kjaer
authors.forename: N
authors.initials: N
authors.lastname: Muñoz
authors.forename: S-E
authors.initials: SE
authors.lastname: Olsson
authors.forename: J
authors.initials: J
authors.lastname: Paavonen
authors.forename: K
authors.initials: K
authors.lastname: Sigurdsson
authors.forename: J
authors.initials: J
authors.lastname: Bryan
authors.forename: M T
authors.initials: MT
authors.lastname: Esser
authors.forename: K
authors.initials: K
authors.lastname: Giacoletti
authors.forename: M
authors.initials: M
authors.lastname: James
authors.forename: F
authors.initials: F
authors.lastname: Taddeo
authors.forename: S
authors.initials: S
authors.lastname: Vuocolo
authors.forename: E
authors.initials: E
authors.lastname: Barr
mesh_terms: D000230:Adenocarcinoma / Q000517:prevention & control*; D000293:Adolescent; D000328:Adult; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D053918:Papillomavirus Vaccines / Q000008:administration & dosage*; D010919:Placebos; D016032:Randomized Controlled Trials as Topic; D012747:Sexual Partners; D002583:Uterine Cervical Neoplasms / Q000517:prevention & control*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000517:prevention & control*
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; D010919:Placebos