title: A phase III clinical study to compare the immunogenicity and safety of the 9-valent and quadrivalent HPV vaccines in men.
abstract: A nine-valent human papilloma virus (9vHPV) vaccine has been developed to prevent infections and diseases related to HPV 6/11/16/18 (as per the licensed quadrivalent HPV (qHPV) vaccine) as well as to five additional oncogenic HPV types (HPV 31/33/45/52/58). The 9vHPV vaccine has the potential to prevent 90% of cervical cancers, HPV-related anal, vaginal and vulval cancers and anogenital warts. We compared the immunogenicity and safety of the 9vHPV vaccine versus the qHPV vaccine in 16-26-year-old men.
  
  
  
  Participants (N=500) were randomised to receive 9vHPV or qHPV vaccines on day 1, month 2 and month 6. Serology testing was performed on day 1 and month 7. HPV type-specific antibody titres (anti-HPV 6/11/16/18/31/33/45/52/58) were determined by competitive Luminex immunoassay and expressed as geometric mean titres and seroconversion rates. Vaccine safety was also assessed.
  
  
  
  The HPV 6/11/16/18 immune responses elicited by the 9vHPV vaccine were comparable with those elicited by the qHPV vaccine. All participants receiving the 9vHPV vaccine seroconverted for HPV 31/33/45/52/58. The 9vHPV and qHPV vaccines showed comparable safety profiles.
  
  
  
  In addition to immune responses to HPV 31/33/45/52/58, a three-dose regimen of the 9vHPV vaccine elicited a similar immune response to HPV 6/11/16/18 when compared with the qHPV vaccine in men aged 16-26years. The safety profile was also similar for the two vaccines. The results from this study support extending the efficacy findings with qHPV vaccine to 9vHPV vaccine in men aged 16-26years. NCT02114385.
authors.affiliation: Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Universiteitsplein 1, 2610 WIlrijk, Belgium. Electronic address: pierre.vandamme@uantwerpen.be.
authors.forename: Pierre
authors.initials: P
authors.lastname: Van Damme
authors.affiliation: VU University Medical Centre, De Boelelaan 1117, 1084HV Amsterdam, The Netherlands. Electronic address: CJLM.Meijer@vumc.nl.
authors.forename: Chris J L M
authors.initials: CJLM
authors.lastname: Meijer
authors.affiliation: Centre for Clinical Trials, Children's Hospital, Universitätsmedizin, Mainz, Germany. Electronic address: Dorothee.kieninger@unimedizin-mainz.de.
authors.forename: Dorothee
authors.initials: D
authors.lastname: Kieninger
authors.affiliation: Sanofi Pasteur MSD, Lyon, France. Electronic address: ASchuyleman@spmsd.com.
authors.forename: Anne
authors.initials: A
authors.lastname: Schuyleman
authors.affiliation: Sanofi Pasteur MSD, Lyon, France. Electronic address: SThomas@spmsd.com.
authors.forename: Stephane
authors.initials: S
authors.lastname: Thomas
authors.affiliation: Merck & Co. Inc., 2000 Galloping Hill Road, Kenilworth, NJ 07033, USA. Electronic address: alain_luxembourg@merck.com.
authors.forename: Alain
authors.initials: A
authors.lastname: Luxembourg
authors.affiliation: Sanofi Pasteur MSD, Lyon, France. Electronic address: baudinmartine@yahoo.fr.
authors.forename: Martine
authors.initials: M
authors.lastname: Baudin
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D004311:Double-Blind Method; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000009:adverse effects / Q000276:immunology* / Q000627:therapeutic use*; D006801:Humans; D000071497:Immunogenicity, Vaccine; D008297:Male; D030361:Papillomavirus Infections / Q000517:prevention & control*; D000069078:Seroconversion; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
keywords: Anogenital cancers; Anogenital warts; Human papilloma virus; Immunogenicity; Nine-valent human papilloma virus vaccine; Safety