XVIII International AIDS Conference


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Quadrivalent HPV vaccine efficacy against HPV 6/11/16/18 infection and disease in men

H. Jessen1, A. Giuliano2, J. Palefsky3, S. Goldstone4, E. Moreira5, M. Penny6, C. Aranda7, E. Vardas8, H. Moi9, R. Hillman10, Y.-H. Chang11, D. Ferris12, D. Rouleau13, J. Bryan14, J.B. Marshall14, S. Vuocolo14, E. Barr14, D. Radley13, R. Haupt14, D. Guris14

1Praxis, Berlin, Germany, 2H. Lee Moffitt Cancer and Research Institute, Detection and Intervention Program, Tampa, United States, 3University of California San Francisco, Department of Medicine, San Francisco, United States, 4Mount Sinai School of Medicine, Ney York, United States, 5Associação Obras Sociais Irma Dulce and Oswaldo Cruz Foundation, Brazilian Ministry of Health, Bahia, Brazil, 6Instittuto de Investigación Nutricional, Lima, Peru, 7University Medical Centre, National Public Health Institute, Morelos, Mexico, 8Ndlela Research and Clinical Trials/University of the Witwatersrand, Faculty of Health Science, Johannesburg, South Africa, 9Olafia STI Clinic/Oslo University Hospital and Faculty of Medicine, Oslo, Norway, 10STI Research Centre/ University of Sydney, Sydney, Australia, 11Division of Urology/ Taipei Veterans General Hospital, Taipei, Taiwan, Province of China, 12Medical College of Georgia, Augusta, United States, 13Centre de Recherche du C.H.U.M., Montréal, Canada, 14Merck & Co., Inc., North Wales, United States

Background: Infection and diseases caused by human papillomavirus (HPV) are common in men. Here we report on the safety of quadrivalent HPV (types 6/11/16/18) vaccine (qHPV) and its efficacy against external genital lesions (EGL) and anogenital HPV 6/11/16/18 infection in males.
Methods: A total of 4,065 healthy men (3,463 heterosexual men and 602 men who have sex with men) aged 16-26 years were enrolled from 18 countries into a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to demonstrate that qHPV vaccine reduced the incidence of HPV 6-, 11-, 16-, or 18-related EGL. Efficacy analyses were conducted in per protocol and intention-to-treat (ITT) populations.
Results: Three HPV 6/11/16/18-related EGL were observed in the per-protocol qHPV vaccine arm and 31 in the per-protocol placebo arm (observed efficacy of 90.4% [95% CI: 69.2, 98.1]). The majority of EGL observed were condylomata acuminata; no cases of penile/perianal/perineal intraepithelial neoplasia were observed in qHPV vaccinees. Efficacy against EGL in the ITT population was 65.5% (95% CI: 45.8, 78.6). Efficacy against HPV 6/11/16/18-related persistent infection and DNA detection at any time was 85.6% (97.5% CI: 73.4, 92.9) and 44.7% (95% CI: 31.5, 55.6), respectively in the per-protocol population and 47.8% (95% CI: 36.0, 57.6) and 27.1% (95% CI: 16.6, 36.3), respectively in the ITT population. Overall, qHPV vaccine was well-tolerated in men, though injection-site pain occurred significantly more frequently among those receiving qHPV vaccine (57% vs. 51%; p< 0.001).
Conclusions: Quadrivalent HPV vaccine effectively prevents HPV 6/11/16/18-related EGL and infection in men 16-26 years of age and has a favorable safety profile.

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