HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.

Detalhes bibliográficos
Autor(a) principal: Palefsky, Joel M
Data de Publicação: 2011
Outros Autores: Giuliano, Anna R, Goldstone, Stephen, Moreira Júnior, Edson Duarte, Aranda, Carlos, Jessen, Heiko, Hillman, Richard J, Ferris, Daron G, Coutlee, Francois, Stoler, Mark H, Marshall, J. Brooke, Radley, David, Vuocolo, Scott, Haupt, Richard M, Guris, Dalya, Garner, Elizabeth I. O
Tipo de documento: Artigo
Idioma: eng
Título da fonte: Repositório Institucional da FIOCRUZ (ARCA)
Texto Completo: https://www.arca.fiocruz.br/handle/icict/9116
Resumo: University of California at San Francisco. Department of Medicine. San Francisco
id CRUZ_56fda8c1959296bf8a0b7c5f3b539b79
oai_identifier_str oai:www.arca.fiocruz.br:icict/9116
network_acronym_str CRUZ
network_name_str Repositório Institucional da FIOCRUZ (ARCA)
repository_id_str 2135
spelling Palefsky, Joel MGiuliano, Anna RGoldstone, StephenMoreira Júnior, Edson DuarteAranda, CarlosJessen, HeikoHillman, Richard JFerris, Daron GCoutlee, FrancoisStoler, Mark HMarshall, J. BrookeRadley, DavidVuocolo, ScottHaupt, Richard MGuris, DalyaGarner, Elizabeth I. O2014-12-05T19:21:07Z2014-12-05T19:21:07Z2011PALEFSKY, J. M. et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. New England Journal of Medicine, v. 365, n. 17, p. 1576-1585, 2011.1533-4406https://www.arca.fiocruz.br/handle/icict/9116engMassachusetts Medical SocietyHPV vaccine against anal HPV infection and anal intraepithelial neoplasia.info:eu-repo/semantics/publishedVersioninfo:eu-repo/semantics/articleUniversity of California at San Francisco. Department of Medicine. San FranciscoRisk Assessment, Detection. Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FLMount Sinai School of Medicine. New YorkAssociação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, BrasilUniversity Medical Center. National Public Health Institute. Cuernavaca,Private Clinic for Infectious Diseases. BerlinUniversity of Sydney. Sexually Transmitted Infections Research Centre. SydneyMedical College of Georgia. AugustaUniversité de Montréal. Centre de Recherche du Centre Hospitalier de l’Université de Montréal. MontrealUniversity of Virginia. CharlottesvilleMerck. North Wales, PAMerck. North Wales, PAMerck. North Wales, PAMerck. North Wales, PAMerck. North Wales, PAMerck. North Wales, PABACKGROUND: The rate of anal cancer is increasing among both women and men, particularly men who have sex with men. Caused by infection with human papillomavirus (HPV), primarily HPV type 16 or 18, anal cancer is preceded by high-grade anal intraepithelial neoplasia (grade 2 or 3). We studied the safety and efficacy of quadrivalent HPV vaccine (qHPV) against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 infection in men who have sex with men. METHODS: In a substudy of a larger double-blind study, we randomly assigned 602 healthy men who have sex with men, 16 to 26 years of age, to receive either qHPV or placebo. The primary efficacy objective was prevention of anal intraepithelial neoplasia or anal cancer related to infection with HPV-6, 11, 16, or 18. Efficacy analyses were performed in intention-to-treat and per-protocol efficacy populations. The rates of adverse events were documented. RESULTS: Efficacy of the qHPV vaccine against anal intraepithelial neoplasia associated with HPV-6, 11, 16, or 18 was 50.3% (95% confidence interval [CI], 25.7 to 67.2) in the intention-to-treat population and 77.5% (95% CI, 39.6 to 93.3) in the per-protocol efficacy population; the corresponding efficacies against anal intraepithelial neoplasia associated with HPV of any type were 25.7% (95% CI, -1.1 to 45.6) and 54.9% (95% CI, 8.4 to 79.1), respectively. Rates of anal intraepithelial neoplasia per 100 person-years were 17.5 in the placebo group and 13.0 in the vaccine group in the intention-to-treat population and 8.9 in the placebo group and 4.0 in the vaccine group in the per-protocol efficacy population. The rate of grade 2 or 3 anal intraepithelial neoplasia related to infection with HPV-6, 11, 16, or 18 was reduced by 54.2% (95% CI, 18.0 to 75.3) in the intention-to-treat population and by 74.9% (95% CI, 8.8 to 95.4) in the per-protocol efficacy population. The corresponding risks of persistent anal infection with HPV-6, 11, 16, or 18 were reduced by 59.4% (95% CI, 43.0 to 71.4) and 94.9% (95% CI, 80.4 to 99.4), respectively. No vaccine-related serious adverse events were reported. CONCLUSIONS: Use of the qHPV vaccine reduced the rates of anal intraepithelial neoplasia, including of grade 2 or 3, among men who have sex with men. The vaccine had a favorable safety profile and may help to reduce the risk of anal cancer. (Funded by Merck and the National Institutes of Health; ClinicalTrials.gov number, NCT00090285Doenças do Ânus/prevenção & controleCarcinoma in Situ/prevenção & controleInfecções por Papillomavirus/prevenção & controleVacinas contra PapillomavirusAdolescenteAdultoDoenças do Ânus/virologiaNeoplasias do Ânus/prevenção & controleNeoplasias do Ânus/virologiaCarcinoma in Situ/virologiaMétodo Duplo-CegoPapillomavirus Humano 11Papillomavirus Humano 16Papillomavirus Humano 18Papillomavirus Humano 6HumanosMasculinoAdulto 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/9116/1/license.txt7d48279ffeed55da8dfe2f8e81f3b81fMD51ORIGINALPalefsky JM HPV vaccine....pdfPalefsky JM HPV vaccine....pdfapplication/pdf556194https://www.arca.fiocruz.br/bitstream/icict/9116/2/Palefsky%20JM%20HPV%20vaccine....pdfffcca15046cbe31b5b5cbdebe4c8dcf4MD52TEXTPalefsky JM HPV vaccine....pdf.txtPalefsky JM HPV vaccine....pdf.txtExtracted texttext/plain47987https://www.arca.fiocruz.br/bitstream/icict/9116/3/Palefsky%20JM%20HPV%20vaccine....pdf.txtf3a42dfd59869424aefce50874f8372eMD53icict/91162023-03-15 14:33:02.806oai:www.arca.fiocruz.br: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ório InstitucionalPUBhttps://www.arca.fiocruz.br/oai/requestrepositorio.arca@fiocruz.bropendoar:21352023-03-15T17:33:02Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)false
dc.title.pt_BR.fl_str_mv HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
title HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
spellingShingle HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
Palefsky, Joel M
Doenças do Ânus/prevenção & controle
Carcinoma in Situ/prevenção & controle
Infecções por Papillomavirus/prevenção & controle
Vacinas contra Papillomavirus
Adolescente
Adulto
Doenças do Ânus/virologia
Neoplasias do Ânus/prevenção & controle
Neoplasias do Ânus/virologia
Carcinoma in Situ/virologia
Método Duplo-Cego
Papillomavirus Humano 11
Papillomavirus Humano 16
Papillomavirus Humano 18
Papillomavirus Humano 6
Humanos
Masculino
Adulto Jovem
title_short HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
title_full HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
title_fullStr HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
title_full_unstemmed HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
title_sort HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
author Palefsky, Joel M
author_facet Palefsky, Joel M
Giuliano, Anna R
Goldstone, Stephen
Moreira Júnior, Edson Duarte
Aranda, Carlos
Jessen, Heiko
Hillman, Richard J
Ferris, Daron G
Coutlee, Francois
Stoler, Mark H
Marshall, J. Brooke
Radley, David
Vuocolo, Scott
Haupt, Richard M
Guris, Dalya
Garner, Elizabeth I. O
author_role author
author2 Giuliano, Anna R
Goldstone, Stephen
Moreira Júnior, Edson Duarte
Aranda, Carlos
Jessen, Heiko
Hillman, Richard J
Ferris, Daron G
Coutlee, Francois
Stoler, Mark H
Marshall, J. Brooke
Radley, David
Vuocolo, Scott
Haupt, Richard M
Guris, Dalya
Garner, Elizabeth I. O
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.author.fl_str_mv Palefsky, Joel M
Giuliano, Anna R
Goldstone, Stephen
Moreira Júnior, Edson Duarte
Aranda, Carlos
Jessen, Heiko
Hillman, Richard J
Ferris, Daron G
Coutlee, Francois
Stoler, Mark H
Marshall, J. Brooke
Radley, David
Vuocolo, Scott
Haupt, Richard M
Guris, Dalya
Garner, Elizabeth I. O
dc.subject.decs.pt_BR.fl_str_mv Doenças do Ânus/prevenção & controle
Carcinoma in Situ/prevenção & controle
Infecções por Papillomavirus/prevenção & controle
Vacinas contra Papillomavirus
Adolescente
Adulto
Doenças do Ânus/virologia
Neoplasias do Ânus/prevenção & controle
Neoplasias do Ânus/virologia
Carcinoma in Situ/virologia
Método Duplo-Cego
Papillomavirus Humano 11
Papillomavirus Humano 16
Papillomavirus Humano 18
Papillomavirus Humano 6
Humanos
Masculino
Adulto Jovem
topic Doenças do Ânus/prevenção & controle
Carcinoma in Situ/prevenção & controle
Infecções por Papillomavirus/prevenção & controle
Vacinas contra Papillomavirus
Adolescente
Adulto
Doenças do Ânus/virologia
Neoplasias do Ânus/prevenção & controle
Neoplasias do Ânus/virologia
Carcinoma in Situ/virologia
Método Duplo-Cego
Papillomavirus Humano 11
Papillomavirus Humano 16
Papillomavirus Humano 18
Papillomavirus Humano 6
Humanos
Masculino
Adulto Jovem
description University of California at San Francisco. Department of Medicine. San Francisco
publishDate 2011
dc.date.issued.fl_str_mv 2011
dc.date.accessioned.fl_str_mv 2014-12-05T19:21:07Z
dc.date.available.fl_str_mv 2014-12-05T19:21:07Z
dc.type.status.fl_str_mv info:eu-repo/semantics/publishedVersion
dc.type.driver.fl_str_mv info:eu-repo/semantics/article
format article
status_str publishedVersion
dc.identifier.citation.fl_str_mv PALEFSKY, J. M. et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. New England Journal of Medicine, v. 365, n. 17, p. 1576-1585, 2011.
dc.identifier.uri.fl_str_mv https://www.arca.fiocruz.br/handle/icict/9116
dc.identifier.issn.none.fl_str_mv 1533-4406
identifier_str_mv PALEFSKY, J. M. et al. HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. New England Journal of Medicine, v. 365, n. 17, p. 1576-1585, 2011.
1533-4406
url https://www.arca.fiocruz.br/handle/icict/9116
dc.language.iso.fl_str_mv eng
language eng
dc.rights.driver.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.publisher.none.fl_str_mv Massachusetts Medical Society
publisher.none.fl_str_mv Massachusetts Medical Society
dc.source.none.fl_str_mv reponame:Repositório Institucional da FIOCRUZ (ARCA)
instname:Fundação Oswaldo Cruz (FIOCRUZ)
instacron:FIOCRUZ
instname_str Fundação Oswaldo Cruz (FIOCRUZ)
instacron_str FIOCRUZ
institution FIOCRUZ
reponame_str Repositório Institucional da FIOCRUZ (ARCA)
collection Repositório Institucional da FIOCRUZ (ARCA)
bitstream.url.fl_str_mv https://www.arca.fiocruz.br/bitstream/icict/9116/1/license.txt
https://www.arca.fiocruz.br/bitstream/icict/9116/2/Palefsky%20JM%20HPV%20vaccine....pdf
https://www.arca.fiocruz.br/bitstream/icict/9116/3/Palefsky%20JM%20HPV%20vaccine....pdf.txt
bitstream.checksum.fl_str_mv 7d48279ffeed55da8dfe2f8e81f3b81f
ffcca15046cbe31b5b5cbdebe4c8dcf4
f3a42dfd59869424aefce50874f8372e
bitstream.checksumAlgorithm.fl_str_mv MD5
MD5
MD5
repository.name.fl_str_mv Repositório Institucional da FIOCRUZ (ARCA) - Fundação Oswaldo Cruz (FIOCRUZ)
repository.mail.fl_str_mv repositorio.arca@fiocruz.br
_version_ 1813009305859784704

Registros relacionados