| Author | Giuliano, Anna R | |
| Author | Palefsky, Joel M | |
| Author | Goldstone, Stephen | |
| Author | Moreira Júnior, Edson Duarte | |
| Author | Penny, Mary E | |
| Author | Aranda, Carlos | |
| Author | Vardas, Eftyhia | |
| Author | Moi, Harald | |
| Author | Jessen, Heiko | |
| Author | Hillman, Richard J | |
| Author | Chang, Yen-Hwa | |
| Author | Ferris, Daron G | |
| Author | Rouleau, Danielle | |
| Author | Bryan, Janine | |
| Author | Marshall, J. Brooke | |
| Author | Vuocolo, Scott | |
| Author | Barr, Eliav | |
| Author | Radley, David | |
| Author | Haupt, Richard M | |
| Author | Dalya, Guris | |
| Access date | 2014-12-09T19:44:44Z | |
| Available date | 2014-12-09T19:44:44Z | |
| Document date | 2011 | |
| 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. | pt_BR |
| ISSN | 1533-4406 | |
| URI | https://www.arca.fiocruz.br/handle/icict/9131 | |
| Language | eng | pt_BR |
| Publisher | Massachusetts Medical Society | pt_BR |
| Rights | open access | pt_BR |
| Title | Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. | pt_BR |
| Type | Article | pt_BR |
| DOI | 10.1056/NEJMoa0909537 | |
| 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.). | pt_BR |
| Affilliation | Risk Assessment, Detection. Tampa, FL / Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL | pt_BR |
| Affilliation | University of California San Francisco. Department of Medicine. San Francisco | pt_BR |
| Affilliation | Mount Sinai School of Medicine. New York | pt_BR |
| Affilliation | Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil | pt_BR |
| Affilliation | Instituto de Investigación Nutricional. Lima, Peru | pt_BR |
| Affilliation | University Medical Center. National Institute of Public Health. Morelos, Mexico | pt_BR |
| Affilliation | University of the Witwatersrand. Faculty of Health Sciences. Ndlela Research and Clinical Trials Unit. Johannesburg, South Africa | pt_BR |
| Affilliation | Oslo University Hospital. Faculty of Medicine. Olafia Sexually Transmitted Infections Clinic. Oslo | pt_BR |
| Affilliation | Private Clinic for Infectious Diseases. Berlin | pt_BR |
| Affilliation | University of Sydney. Sexually Transmitted Infections Research Centre. Sydney | pt_BR |
| Affilliation | Taipei Veterans General Hospital. Division of Urology. Department of Surgery. Taipei, Taiwan | pt_BR |
| Affilliation | Medical College of Georgia. Augusta | pt_BR |
| Affilliation | Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA | pt_BR |
| Affilliation | Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA | pt_BR |
| Affilliation | Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA | pt_BR |
| Affilliation | Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA | pt_BR |
| Affilliation | Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA | pt_BR |
| Affilliation | Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA | pt_BR |
| Affilliation | Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA | pt_BR |
| Affilliation | Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PA | pt_BR |
| DeCS | Doenças dos Genitais Masculinos/prevenção & controle | pt_BR |
| DeCS | Infecções por Papillomavirus/prevenção & controle | pt_BR |
| DeCS | Vacinas contra Papillomavirus | pt_BR |
| DeCS | Adolescente | pt_BR |
| DeCS | Adulto | pt_BR |
| DeCS | Método Duplo-Cego | pt_BR |
| DeCS | Alphapapillomavirus | pt_BR |
| DeCS | Doenças dos Genitais Masculinos/epidemiologia | pt_BR |
| DeCS | Doenças dos Genitais Masculinos/virologia | pt_BR |
| DeCS | Humanos | pt_BR |
| DeCS | Incidência | pt_BR |
| DeCS | Injeções/efeitos adversos | pt_BR |
| DeCS | Análise de Intenção de Tratamento | pt_BR |
| DeCS | Masculino | pt_BR |
| DeCS | Infecções por Papillomavirus/epidemiologia | pt_BR |
| DeCS | Infecções por Papillomavirus/virologia | pt_BR |
| DeCS | Vacinas contra Papillomavirus/efeitos adversos | pt_BR |
| DeCS | Resultado do Tratamento | pt_BR |
| DeCS | Adulto Jovem | pt_BR |
