title: Immunogenicity of the quadrivalent human papillomavirus (type 6/11/16/18) vaccine in males 16 to 26 years old.
abstract: Human papillomavirus (HPV) infection can lead to significant disease in males, including anogenital warts, intraepithelial neoplasias, and several types of oral and anogenital cancers. The quadrivalent HPV (type 6/11/16/18) L1 virus-like particle (VLP) vaccine (qHPV vaccine; Gardasil) has recently been demonstrated to prevent persistent infection and associated disease related to vaccine HPV types in males. We report the overall immunogenicity results from a trial of the quadrivalent HPV vaccine in males. Overall, 3,463 heterosexual men and 602 men who had sex with men were enrolled into a randomized, placebo-controlled, double-blind safety, immunogenicity, and efficacy study. Serum samples were collected prior to vaccination at day 1 and at months 7, 24, and 36 postvaccination. Immunogenicity was evaluated with a multiplex, competitive Luminex immunoassay. Almost all subjects (97.4 to 99.2%) seroconverted for vaccine HPV types by month 7. At month 36, 88.9%, 94.0%, 97.9%, and 57.0% of subjects were still seropositive for HPV-6, -11, -16, and -18, respectively. For all vaccine HPV types, black subjects had significantly higher antibody titers at month 7 than did both Caucasian and Asian subjects. An anamnestic antibody response was seen in men seropositive before vaccination. The vaccine was highly immunogenic in males 16 to 23 years of age; responses were comparable to those observed in women. Furthermore, the immune responses were consistent with the established efficacy of the vaccine in the prevention of incident and persistent HPV infection, anogenital warts, and anal intraepithelial neoplasia.
authors.affiliation: STI Research Centre, University of Sydney, Sydney, Australia. richard.hillman@sydney.edu.au
authors.forename: Richard J
authors.initials: RJ
authors.lastname: Hillman
authors.forename: Anna R
authors.initials: AR
authors.lastname: Giuliano
authors.forename: Joel M
authors.initials: JM
authors.lastname: Palefsky
authors.forename: Stephen
authors.initials: S
authors.lastname: Goldstone
authors.forename: Edson D
authors.initials: ED
authors.lastname: Moreira
authors.forename: Eftyhia
authors.initials: E
authors.lastname: Vardas
authors.forename: Carlos
authors.initials: C
authors.lastname: Aranda
authors.forename: Heiko
authors.initials: H
authors.lastname: Jessen
authors.forename: Daron G
authors.initials: DG
authors.lastname: Ferris
authors.forename: Francois
authors.initials: F
authors.lastname: Coutlee
authors.forename: J Brooke
authors.initials: JB
authors.lastname: Marshall
authors.forename: Scott
authors.initials: S
authors.lastname: Vuocolo
authors.forename: Richard M
authors.initials: RM
authors.lastname: Haupt
authors.forename: Dalya
authors.initials: D
authors.lastname: Guris
authors.forename: Elizabeth I O
authors.initials: EI
authors.lastname: Garner
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002278:Carcinoma in Situ / Q000517:prevention & control* / Q000821:virology; D003218:Condylomata Acuminata / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D004311:Double-Blind Method; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D052140:Human papillomavirus 11 / Q000276:immunology; D052162:Human papillomavirus 16 / Q000276:immunology; D052161:Human papillomavirus 18 / Q000276:immunology; D052163:Human papillomavirus 6 / Q000276:immunology; D006801:Humans; D008297:Male; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000276:immunology*; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines