title: Immunogenicity and safety of the 9-valent HPV vaccine in men.
abstract: OBJECTIVE
  This study was designed to evaluate the immunogenicity and tolerability of a prophylactic 9-valent HPV (types 6/11/16/18/31/33/45/52/58) VLP (9vHPV) vaccine in young men 16-26 years of age in comparison to young women 16-26 years of age (the population that was used to establish 9vHPV vaccine efficacy). Safety and immunogenicity data from this study will be used to bridge 9vHPV vaccine efficacy findings in 16-26 year old women to 16-26 year old men.
  
  
  METHODS
  This study enrolled 1106 heterosexual men (HM) and 1101 women who had not yet received HPV vaccination. In addition, 313 men having sex with men (MSM) were enrolled and were evaluated separately for immunogenicity because previous results showed that antibody responses to quadrivalent HPV (types 6/11/16/18) VLP (qHPV) vaccine were lower in MSM than in HM. All subjects were administered a 3-dose regimen (Day 1, Month 2, Month 6) of 9vHPV vaccine. Serum samples were collected for anti-HPV assays. Safety information was collected for ∼ 12 months.
  
  
  RESULTS
  The geometric mean titers (GMTs) for HPV types 6, 11, 16, 18, 31, 33, 45, 52, and 58 for HM were non-inferior to those of women at Month 7. For all vaccine HPV types, Month 7 GMTs were numerically lower in MSM than in HM. Over 99.5% of subjects were seropositive at Month 7 for each vaccine HPV type. Administration of 9vHPV vaccine to both 16-26 year old men and women was generally well tolerated.
  
  
  CONCLUSIONS
  These results support bridging the efficacy findings with 9vHPV vaccine in young women 16-26 years of age to men 16-26 years of age.
authors.affiliation: Unit of Infections and Cancer, Cancer Epidemiology Research Program, Catalan Institute of Oncology (ICO), IDIBELL, CIBERESP, L'Hospitalet de Llobregat, Catalonia, Spain. Electronic address: xcastellsague@iconcologia.net.
authors.forename: X
authors.initials: X
authors.lastname: Castellsagué
authors.affiliation: Center for Infection Research in Cancer (CIRC) at Moffitt Cancer Center, Tampa, FL, USA.
authors.forename: A R
authors.initials: AR
authors.lastname: Giuliano
authors.affiliation: Icahn School of Medicine at Mount Sinai, New York, NY, USA.
authors.forename: S
authors.initials: S
authors.lastname: Goldstone
authors.affiliation: Research Unit, Pablo Tobon Uribe Hospital Medellin, Medellín, Colombia.
authors.forename: A
authors.initials: A
authors.lastname: Guevara
authors.affiliation: Department of Gynaecology and Obstetrics, Odense University Hospital, Odense, Denmark.
authors.forename: O
authors.initials: O
authors.lastname: Mogensen
authors.affiliation: Department of Medicine, University of California San Francisco, San Francisco, CA, USA.
authors.forename: J M
authors.initials: JM
authors.lastname: Palefsky
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: T
authors.initials: T
authors.lastname: Group
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: C
authors.initials: C
authors.lastname: Shields
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: K
authors.initials: K
authors.lastname: Liu
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: R
authors.initials: R
authors.lastname: Maansson
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: A
authors.initials: A
authors.lastname: Luxembourg
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: S S
authors.initials: SS
authors.lastname: Kaplan
mesh_terms: D000293:Adolescent; D000328:Adult; D005260:Female; D006801:Humans; D007115:Immunization Schedule; D008297:Male; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D053918:Papillomavirus Vaccines
keywords: Cancer; HPV; Men; Papillomavirus; Vaccine