Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.
| Autor(a) principal: | |
|---|---|
| Data de Publicação: | 2011 |
| Outros Autores: | , , , , , , , , , , , , , , , , , , |
| Tipo de documento: | Artigo |
| Idioma: | eng |
| Título da fonte: | Repositório Institucional da FIOCRUZ (ARCA) |
| Texto Completo: | https://www.arca.fiocruz.br/handle/icict/9131 |
Resumo: | Risk Assessment, Detection. Tampa, FL / Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL |
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Giuliano, Anna RPalefsky, Joel MGoldstone, StephenMoreira Júnior, Edson DuartePenny, Mary EAranda, CarlosVardas, EftyhiaMoi, HaraldJessen, HeikoHillman, Richard JChang, Yen-HwaFerris, Daron GRouleau, DanielleBryan, JanineMarshall, J. BrookeVuocolo, ScottBarr, EliavRadley, DavidHaupt, Richard MDalya, Guris2014-12-09T19:44:44Z2014-12-09T19:44:44Z2011GIULIANO, 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, 2011.1533-4406https://www.arca.fiocruz.br/handle/icict/913110.1056/NEJMoa0909537engMassachusetts Medical SocietyEfficacy of quadrivalent HPV vaccine against HPV Infection and disease in males.info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleRisk Assessment, Detection. Tampa, FL / Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FLUniversity of California San Francisco. Department of Medicine. San FranciscoMount Sinai School of Medicine. New YorkAssociação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilInstituto de Investigación Nutricional. Lima, PeruUniversity Medical Center. National Institute of Public Health. Morelos, MexicoUniversity of the Witwatersrand. Faculty of Health Sciences. Ndlela Research and Clinical Trials Unit. Johannesburg, South AfricaOslo University Hospital. Faculty of Medicine. Olafia Sexually Transmitted Infections Clinic. OsloPrivate Clinic for Infectious Diseases. BerlinUniversity of Sydney. Sexually Transmitted Infections Research Centre. SydneyTaipei Veterans General Hospital. Division of Urology. Department of Surgery. Taipei, TaiwanMedical College of Georgia. AugustaCentre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PACentre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PACentre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PACentre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PACentre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PACentre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PACentre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PACentre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal. North Wales, PA / Merck. North Wales, PABACKGROUND: 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.).Doenças dos Genitais Masculinos/prevenção & controleInfecções por Papillomavirus/prevenção & controleVacinas contra PapillomavirusAdolescenteAdultoMétodo Duplo-CegoAlphapapillomavirusDoenças dos Genitais Masculinos/epidemiologiaDoenças dos Genitais Masculinos/virologiaHumanosIncidênciaInjeções/efeitos adversosAnálise de Intenção de TratamentoMasculinoInfecções por Papillomavirus/epidemiologiaInfecções por Papillomavirus/virologiaVacinas contra Papillomavirus/efeitos adversosResultado do TratamentoAdulto Joveminfo:eu-repo/semantics/openAccessreponame:Repositório Institucional da FIOCRUZ (ARCA)instname:Fundação Oswaldo Cruz (FIOCRUZ)instacron:FIOCRUZLICENSElicense.txtlicense.txttext/plain; charset=utf-81914https://www.arca.fiocruz.br/bitstream/icict/9131/1/license.txt7d48279ffeed55da8dfe2f8e81f3b81fMD51ORIGINALGiuliano AR Efficacy....pdfGiuliano AR Efficacy....pdfapplication/pdf427095https://www.arca.fiocruz.br/bitstream/icict/9131/2/Giuliano%20AR%20Efficacy....pdf0157983b386757f031d1f55aa577498cMD52TEXTGiuliano AR Efficacy....pdf.txtGiuliano AR Efficacy....pdf.txtExtracted texttext/plain51543https://www.arca.fiocruz.br/bitstream/icict/9131/3/Giuliano%20AR%20Efficacy....pdf.txt36357abe442df5761e07922043545e7eMD53icict/91312023-03-15 14:33:11.065oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-03-15T17:33:11Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false |
| dc.title.pt_BR.fl_str_mv |
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. |
| title |
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. |
| spellingShingle |
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. Giuliano, Anna R 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 |
| title_short |
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. |
| title_full |
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. |
| title_fullStr |
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. |
| title_full_unstemmed |
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. |
| title_sort |
Efficacy of quadrivalent HPV vaccine against HPV Infection and disease in males. |
| author |
Giuliano, Anna R |
| author_facet |
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 |
| author_role |
author |
| author2 |
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 |
| author2_role |
author author author author author author author author author author author author author author author author author author author |
| dc.contributor.author.fl_str_mv |
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 |
| dc.subject.decs.pt_BR.fl_str_mv |
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 |
| topic |
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 |
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Risk Assessment, Detection. Tampa, FL / Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL |
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2011 |
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2011 |
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2014-12-09T19:44:44Z |
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2014-12-09T19:44:44Z |
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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. |
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https://www.arca.fiocruz.br/handle/icict/9131 |
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1533-4406 |
| dc.identifier.doi.none.fl_str_mv |
10.1056/NEJMoa0909537 |
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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. 1533-4406 10.1056/NEJMoa0909537 |
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Massachusetts Medical Society |
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Massachusetts Medical Society |
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