title: Immunogenicity and safety of human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine in healthy boys aged 10-18 years.
abstract: The human papillomavirus (HPV)-16/18 AS04-adjuvanted vaccine (Cervarix) has been shown to be well-tolerated and immunogenic in females aged 10 to 55 years, and up to 100% effective for the prevention of HPV-16/18 infection and associated precancerous cervical lesions in females aged 15 to 25 years. This study is the first to evaluate the immunogenicity and safety of the vaccine in males.
  
  
  
  Healthy males aged 10 to 18 years were randomized (2:1 ratio) to receive HPV-16/18 AS04-adjuvanted vaccine (n = 181) or hepatitis B virus (HBV) control vaccine (n = 89) at 0, 1, and 6 months, and were followed for 7 months.
  
  
  
  All initially seronegative subjects in the HPV-16/18 group seroconverted for HPV-16 and 18 (ELISA) at month 2. At month 7, all subjects were seropositive, and the HPV-16 and -18 antibody levels were, respectively, four- and twofold higher than at month 2. The anti-HPV-16 and -18 antibody responses for males aged 10 to 18 years and 10 to 14 years, respectively, were higher than those reported for females aged 15 to 25 years and 10 to 14 years, respectively, in a previous study. The reactogenicity profiles of the HPV-16/18 AS04 and HBV vaccines were similar, except that pain and swelling at the injection site were more common in the HPV-16/18 group. However, vaccine-related symptoms did not affect compliance with the three-dose course, which was equally high (97%) in both groups.
  
  
  
  The HPV-16/18 AS04-adjuvanted vaccine is immunogenic and well tolerated in boys aged 10 to 18 years. However, further data on the potential public health benefits of vaccination of boys are required before any recommendations can be made.
authors.affiliation: School of Public Health, 33014 University of Tampere, Tampere, Finland.
authors.forename: Tiina
authors.initials: T
authors.lastname: Petäjä
authors.forename: Heli
authors.initials: H
authors.lastname: Keränen
authors.forename: Tiina
authors.initials: T
authors.lastname: Karppa
authors.forename: Anna
authors.initials: A
authors.lastname: Kawa
authors.forename: Sirkku
authors.initials: S
authors.lastname: Lantela
authors.forename: Mari
authors.initials: M
authors.lastname: Siitari-Mattila
authors.forename: Helena
authors.initials: H
authors.lastname: Levänen
authors.forename: Tuomas
authors.initials: T
authors.lastname: Tocklin
authors.forename: Olivier
authors.initials: O
authors.lastname: Godeaux
authors.forename: Matti
authors.initials: M
authors.lastname: Lehtinen
authors.forename: Gary
authors.initials: G
authors.lastname: Dubin
mesh_terms: D000293:Adolescent; D002648:Child; D052162:Human papillomavirus 16 / Q000276:immunology*; D052161:Human papillomavirus 18 / Q000276:immunology*; D006801:Humans; D008297:Male; D030361:Papillomavirus Infections / Q000097:blood / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000097:blood / Q000276:immunology*
chemical_list: D053918:Papillomavirus Vaccines; C510352:human papillomavirus vaccine, L1 type 16, 18