Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/9131
Title: Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.
Authors: Giuliano, Anna R
Palefsky, Joel M
Goldstone, Stephen
Moreira Júnior, Edson Duarte
Penny, Mary E
Aranda, Carlos
Vardas, Eftyhia
Moi, Harald
Jessen, Heiko
Hillman, Richard J
Chang, Yen-Hwa
Ferris, Daron G
Rouleau, Danielle
Bryan, Janine
Marshall, J. Brooke
Vuocolo, Scott
Barr, Eliav
Radley, David
Haupt, Richard M
Dalya, Guris
Affilliation: Risk Assessment, Detection. Tampa, FL / Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL
University of California San Francisco. Department of Medicine. San Francisco
Mount Sinai School of Medicine. New York
Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
Instituto de Investigación Nutricional. Lima, Peru
University Medical Center. National Institute of Public Health. Morelos, Mexico
University of the Witwatersrand. Faculty of Health Sciences. Ndlela Research and Clinical Trials Unit. Johannesburg, South Africa
Oslo University Hospital. Faculty of Medicine. Olafia Sexually Transmitted Infections Clinic. Oslo
Private Clinic for Infectious Diseases. Berlin
University of Sydney. Sexually Transmitted Infections Research Centre. Sydney
Taipei Veterans General Hospital. Division of Urology. Department of Surgery. Taipei, Taiwan
Medical College of Georgia. Augusta
Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA
Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA
Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA
Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA
Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA
Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA
Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA
Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA
Abstract: BACKGROUND: Infection with human papillomavirus (HPV) and diseases caused by HPV are common in boys and men. We report on the safety of a quadrivalent vaccine (active against HPV types 6, 11, 16, and 18) and on its efficacy in preventing the development of external genital lesions and anogenital HPV infection in boys and men. METHODS: We enrolled 4065 healthy boys and men 16 to 26 years of age, from 18 countries in a randomized, placebo-controlled, double-blind trial. The primary efficacy objective was to show that the quadrivalent HPV vaccine reduced the incidence of external genital lesions related to HPV-6, 11, 16, or 18. Efficacy analyses were conducted in a per-protocol population, in which subjects received all three vaccinations and were negative for relevant HPV types at enrollment, and in an intention-to-treat population, in which subjects received vaccine or placebo, regardless of baseline HPV status. RESULTS: In the intention-to-treat population, 36 external genital lesions were seen in the vaccine group as compared with 89 in the placebo group, for an observed efficacy of 60.2% (95% confidence interval [CI], 40.8 to 73.8); the efficacy was 65.5% (95% CI, 45.8 to 78.6) for lesions related to HPV-6, 11, 16, or 18. In the per-protocol population, efficacy against lesions related to HPV-6, 11, 16, or 18 was 90.4% (95% CI, 69.2 to 98.1). Efficacy with respect to persistent infection with HPV-6, 11, 16, or 18 and detection of related DNA at any time was 47.8% (95% CI, 36.0 to 57.6) and 27.1% (95% CI, 16.6 to 36.3), respectively, in the intention-to-treat population and 85.6% (97.5% CI, 73.4 to 92.9) and 44.7% (95% CI, 31.5 to 55.6) in the per-protocol population. Injection-site pain was significantly more frequent among subjects receiving quadrivalent HPV vaccine than among those receiving placebo (57% vs. 51%, P<0.001). CONCLUSIONS: Quadrivalent HPV vaccine prevents infection with HPV-6, 11, 16, and 18 and the development of related external genital lesions in males 16 to 26 years of age. (Funded by Merck and others; ClinicalTrials.gov number, NCT00090285.).
DeCS: Doenças dos Genitais Masculinos/prevenção & controle
Infecções por Papillomavirus/prevenção & controle
Vacinas contra Papillomavirus
Adolescente
Adulto
Método Duplo-Cego
Alphapapillomavirus
Doenças dos Genitais Masculinos/epidemiologia
Doenças dos Genitais Masculinos/virologia
Humanos
Incidência
Injeções/efeitos adversos
Análise de Intenção de Tratamento
Masculino
Infecções por Papillomavirus/epidemiologia
Infecções por Papillomavirus/virologia
Vacinas contra Papillomavirus/efeitos adversos
Resultado do Tratamento
Adulto Jovem
Issue Date: 2011
Publisher: Massachusetts Medical Society
Citation: GIULIANO, A. R. et al. Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. New England Journal of Medicine, v. 364, n. 5, p. 401-411, 2011.
DOI: 10.1056/NEJMoa0909537
ISSN: 1533-4406
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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