title: Prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in young women: a randomised double-blind placebo-controlled multicentre phase II efficacy trial.
abstract: BACKGROUND
  A randomised double-blind placebo-controlled phase II study was done to assess the efficacy of a prophylactic quadrivalent vaccine targeting the human papillomavirus (HPV) types associated with 70% of cervical cancers (types 16 and 18) and with 90% of genital warts (types 6 and 11).
  
  
  METHODS
  277 young women (mean age 20.2 years [SD 1.7]) were randomly assigned to quadrivalent HPV (20 microg type 6, 40 microg type 11, 40 microg type 16, and 20 microg type 18) L1 virus-like-particle (VLP) vaccine and 275 (mean age 20.0 years [1.7]) to one of two placebo preparations at day 1, month 2, and month 6. For 36 months, participants underwent regular gynaecological examinations, cervicovaginal sampling for HPV DNA, testing for serum antibodies to HPV, and Pap testing. The primary endpoint was the combined incidence of infection with HPV 6, 11, 16, or 18, or cervical or external genital disease (ie, persistent HPV infection, HPV detection at the last recorded visit, cervical intraepithelial neoplasia, cervical cancer, or external genital lesions caused by the HPV types in the vaccine). Main analyses were done per protocol.
  
  
  RESULTS
  Combined incidence of persistent infection or disease with HPV 6, 11, 16, or 18 fell by 90% (95% CI 71-97, p<0.0001) in those assigned vaccine compared with those assigned placebo.
  
  
  CONCLUSIONS
  A vaccine targeting HPV types 6, 11, 16, 18 could substantially reduce the acquisition of infection and clinical disease caused by common HPV types.
authors.affiliation: Department of Virology, Ludwig Institute for Cancer Research, Sao Paulo, Brazil. llvilla@ludwig.org.br <llvilla@ludwig.org.br>
authors.forename: Luisa L
authors.initials: LL
authors.lastname: Villa
authors.forename: Ronaldo L R
authors.initials: RL
authors.lastname: Costa
authors.forename: Carlos A
authors.initials: CA
authors.lastname: Petta
authors.forename: Rosires P
authors.initials: RP
authors.lastname: Andrade
authors.forename: Kevin A
authors.initials: KA
authors.lastname: Ault
authors.forename: Anna R
authors.initials: AR
authors.lastname: Giuliano
authors.forename: Cosette M
authors.initials: CM
authors.lastname: Wheeler
authors.forename: Laura A
authors.initials: LA
authors.lastname: Koutsky
authors.forename: Christian
authors.initials: C
authors.lastname: Malm
authors.forename: Matti
authors.initials: M
authors.lastname: Lehtinen
authors.forename: Finn Egil
authors.initials: FE
authors.lastname: Skjeldestad
authors.forename: Sven-Eric
authors.initials: SE
authors.lastname: Olsson
authors.forename: Margareta
authors.initials: M
authors.lastname: Steinwall
authors.forename: Darron R
authors.initials: DR
authors.lastname: Brown
authors.forename: Robert J
authors.initials: RJ
authors.lastname: Kurman
authors.forename: Brigitte M
authors.initials: BM
authors.lastname: Ronnett
authors.forename: Mark H
authors.initials: MH
authors.lastname: Stoler
authors.forename: Alex
authors.initials: A
authors.lastname: Ferenczy
authors.forename: Diane M
authors.initials: DM
authors.lastname: Harper
authors.forename: Gretchen M
authors.initials: GM
authors.lastname: Tamms
authors.forename: Jimmy
authors.initials: J
authors.lastname: Yu
authors.forename: Lisa
authors.initials: L
authors.lastname: Lupinacci
authors.forename: Radha
authors.initials: R
authors.lastname: Railkar
authors.forename: Frank J
authors.initials: FJ
authors.lastname: Taddeo
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
authors.forename: Mark T
authors.initials: MT
authors.lastname: Esser
authors.forename: Heather L
authors.initials: HL
authors.lastname: Sings
authors.forename: Alfred J
authors.initials: AJ
authors.lastname: Saah
authors.forename: Eliav
authors.initials: E
authors.lastname: Barr
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000096:biosynthesis; D036022:Capsid Proteins; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D009856:Oncogene Proteins, Viral / Q000276:immunology*; D027383:Papillomaviridae / Q000276:immunology; D030361:Papillomavirus Infections / Q000453:epidemiology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines; D010919:Placebos; D014412:Tumor Virus Infections / Q000517:prevention & control; D002583:Uterine Cervical Neoplasms / Q000453:epidemiology; D014765:Viral Vaccines / Q000627:therapeutic use*; D002578:Uterine Cervical Dysplasia / Q000453:epidemiology
chemical_list: D000914:Antibodies, Viral; D036022:Capsid Proteins; C114580:HPV L1 protein, Human papillomavirus; D009856:Oncogene Proteins, Viral; D053918:Papillomavirus Vaccines; D010919:Placebos; D014765:Viral Vaccines