title: Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.
abstract: BACKGROUND
  Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men.
  
  
  METHODS
  We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status.
  
  
  RESULTS
  In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001).
  
  
  CONCLUSIONS
  Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.).
authors.affiliation: Risk Assessment, Detection, and Intervention Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, FL 33612, USA. anna.giuliano@moffitt.org
authors.forename: Anna R
authors.initials: AR
authors.lastname: Giuliano
authors.forename: Joel M
authors.initials: JM
authors.lastname: Palefsky
authors.forename: Stephen
authors.initials: S
authors.lastname: Goldstone
authors.forename: Edson D
authors.initials: ED
authors.lastname: Moreira
authors.forename: Mary E
authors.initials: ME
authors.lastname: Penny
authors.forename: Carlos
authors.initials: C
authors.lastname: Aranda
authors.forename: Eftyhia
authors.initials: E
authors.lastname: Vardas
authors.forename: Harald
authors.initials: H
authors.lastname: Moi
authors.forename: Heiko
authors.initials: H
authors.lastname: Jessen
authors.forename: Richard
authors.initials: R
authors.lastname: Hillman
authors.forename: Yen-Hwa
authors.initials: YH
authors.lastname: Chang
authors.forename: Daron
authors.initials: D
authors.lastname: Ferris
authors.forename: Danielle
authors.initials: D
authors.lastname: Rouleau
authors.forename: Janine
authors.initials: J
authors.lastname: Bryan
authors.forename: J Brooke
authors.initials: JB
authors.lastname: Marshall
authors.forename: Scott
authors.initials: S
authors.lastname: Vuocolo
authors.forename: Eliav
authors.initials: E
authors.lastname: Barr
authors.forename: David
authors.initials: D
authors.lastname: Radley
authors.forename: Richard M
authors.initials: RM
authors.lastname: Haupt
authors.forename: Dalya
authors.initials: D
authors.lastname: Guris
mesh_terms: D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus; D004311:Double-Blind Method; D005832:Genital Diseases, Male / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D015994:Incidence; D007267:Injections / Q000009:adverse effects; D057194:Intention to Treat Analysis; D008297:Male; D030361:Papillomavirus Infections / Q000453:epidemiology / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000009:adverse effects; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines