title: End-of-study safety, immunogenicity, and efficacy of quadrivalent HPV (types 6, 11, 16, 18) recombinant vaccine in adult women 24-45 years of age.
abstract: BACKGROUND
  Previous analyses from a randomised trial in women aged 24-45 years have shown the quadrivalent human papillomavirus (qHPV) vaccine to be efficacious in the prevention of infection, cervical intraepithelial neoplasia (CIN), and external genital lesions (EGLs) related to HPV 6/11/16/18. In this report, we present end-of-study efficacy, safety, and immunogenicity data with a median follow-up time of 4.0 years.
  
  
  METHODS
  We enrolled 3819 24-45-year-old women with no history of cervical disease or genital warts in the past 5 years. Women received quadrivalent vaccine or placebo at day 1, and at months 2 and 6. Ascertainment of CIN/EGL was accomplished through Pap testing, genital inspection, and cervicovaginal sampling (every 6 months). The main analysis was conducted in a per-protocol efficacy population (that received three doses, was naive to the relevant HPV types at day 1, and remained free of infection through month 7). Efficacy was also estimated in other naive and non-naive populations.
  
  
  RESULTS
  Vaccine efficacy against the combined incidence of persistent infection, CIN/EGL related to HPV6/11/16/18 in the per-protocol population was 88.7% (95% CI: 78.1, 94.8). Efficacy for women who were seropositive and DNA negative for the relevant vaccine HPV type at the time of enrolment who received at least 1 dose was 66.9% (95% CI: 4.3, 90.6). At month 48, 91.5, 92.0, 97.4, and 47.9% of vaccinated women were seropositive to HPV 6/11/16/18, respectively. No serious vaccine-related adverse experiences were reported.
  
  
  CONCLUSIONS
  The qHPV vaccine demonstrated high efficacy, immunogenicity, and acceptable safety in women aged 24-45 years, regardless of previous exposure to HPV vaccine type.
authors.affiliation: Unit of Infections and Cancer, Cancer Epidemiology Research Program, IDIBELL, Institut Català d'Oncologia-ICO, CIBER-ESP, L'Hospitalet de Llobregat, Catalonia 08907, Spain. xcastellsague@iconcologia.net
authors.forename: X
authors.initials: X
authors.lastname: Castellsagué
authors.forename: N
authors.initials: N
authors.lastname: Muñoz
authors.forename: P
authors.initials: P
authors.lastname: Pitisuttithum
authors.forename: D
authors.initials: D
authors.lastname: Ferris
authors.forename: J
authors.initials: J
authors.lastname: Monsonego
authors.forename: K
authors.initials: K
authors.lastname: Ault
authors.forename: J
authors.initials: J
authors.lastname: Luna
authors.forename: E
authors.initials: E
authors.lastname: Myers
authors.forename: S
authors.initials: S
authors.lastname: Mallary
authors.forename: O M
authors.initials: OM
authors.lastname: Bautista
authors.forename: J
authors.initials: J
authors.lastname: Bryan
authors.forename: S
authors.initials: S
authors.lastname: Vuocolo
authors.forename: R M
authors.initials: RM
authors.lastname: Haupt
authors.forename: A
authors.initials: A
authors.lastname: Saah
mesh_terms: D000328:Adult; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D007390:International Agencies; D008875:Middle Aged; D015337:Multicenter Studies as Topic; D010051:Ovarian Neoplasms / Q000276:immunology* / Q000517:prevention & control* / Q000821:virology; D027383:Papillomaviridae / Q000276:immunology*; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control / Q000821:virology; D053918:Papillomavirus Vaccines / Q000276:immunology / Q000627:therapeutic use*; D016032:Randomized Controlled Trials as Topic; D016896:Treatment Outcome; D014611:Vaccination; D014614:Vaccines, Synthetic / Q000276:immunology / Q000627:therapeutic use*; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000276:immunology / Q000517:prevention & control / Q000821:virology
chemical_list: D053918:Papillomavirus Vaccines; D014614:Vaccines, Synthetic