title: Comparison of the immunogenicity and reactogenicity of a prophylactic quadrivalent human papillomavirus (types 6, 11, 16, and 18) L1 virus-like particle vaccine in male and female adolescents and young adult women.
abstract: OBJECTIVE
  Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been shown to prevent type-specific human papillomavirus infection and associated clinical disease. We conducted a noninferiority immunogenicity study to bridge the efficacy findings in young women to preadolescent and adolescent girls and boys, who represent a primary target for human papillomavirus vaccination.
  
  
  METHODS
  We enrolled 506 girls and 510 boys (10-15 years of age) and 513 females (16-23 years of age). Participants were vaccinated on day 1, at month 2, and at month 6, and serology testing was performed on day 1 and at months 3 and 7 on blinded samples. Neutralizing antibody concentrations were determined using type-specific immunoassays and summarized as geometric mean titers and seroconversion rates. Vaccine tolerability also was assessed.
  
  
  RESULTS
  By month 7, seroconversion rates were > or = 99% for all 4 human papillomavirus types in each group. By month 7, compared with women, anti-human papilloma virus geometric mean titers in girls or boys were noninferior and were 1.7- to 2.7-fold higher. Most (> 97%) injection-site adverse events were mild to moderate in intensity. Significantly more boys (13.8%) and girls (12.8%) than women (7.3%) reported fevers > or = 37.8 degrees C within 5 days of vaccination. Most (96.4%) fevers were mild (< 39 degrees C).
  
  
  CONCLUSIONS
  Noninferior immunogenic responses to all 4 human papillomavirus types in the quadrivalent vaccine permit the bridging of efficacy data that were generated in young women to girls. The results in boys lend support for the implementation of gender-neutral human papillomavirus vaccination programs. This vaccine generally was well tolerated.
authors.affiliation: Kentucky Pediatric Research, Inc, 201 S 5th St, Bardstown, KY 40004, USA. slblock@pol.net
authors.forename: Stan L
authors.initials: SL
authors.lastname: Block
authors.forename: Terry
authors.initials: T
authors.lastname: Nolan
authors.forename: Carlos
authors.initials: C
authors.lastname: Sattler
authors.forename: Eliav
authors.initials: E
authors.lastname: Barr
authors.forename: Katherine E D
authors.initials: KE
authors.lastname: Giacoletti
authors.forename: Colin D
authors.initials: CD
authors.lastname: Marchant
authors.forename: Xavier
authors.initials: X
authors.lastname: Castellsagué
authors.forename: Steven A
authors.initials: SA
authors.lastname: Rusche
authors.forename: Suzanne
authors.initials: S
authors.lastname: Lukac
authors.forename: Janine T
authors.initials: JT
authors.lastname: Bryan
authors.forename: Paul F
authors.initials: PF
authors.lastname: Cavanaugh
authors.forename: Keith S
authors.initials: KS
authors.lastname: Reisinger
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D008297:Male; D027383:Papillomaviridae / Q000276:immunology; D053918:Papillomavirus Vaccines; D014765:Viral Vaccines / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines; D014765:Viral Vaccines