Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/9116
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dc.contributor.authorPalefsky, Joel M
dc.contributor.authorGiuliano, Anna R
dc.contributor.authorGoldstone, Stephen
dc.contributor.authorMoreira Júnior, Edson Duarte
dc.contributor.authorAranda, Carlos
dc.contributor.authorJessen, Heiko
dc.contributor.authorHillman, Richard J
dc.contributor.authorFerris, Daron G
dc.contributor.authorCoutlee, Francois
dc.contributor.authorStoler, Mark H
dc.contributor.authorMarshall, J. Brooke
dc.contributor.authorRadley, David
dc.contributor.authorVuocolo, Scott
dc.contributor.authorHaupt, Richard M
dc.contributor.authorGuris, Dalya
dc.contributor.authorGarner, Elizabeth I. O
dc.date.accessioned2014-12-05T19:21:07Z
dc.date.available2014-12-05T19:21:07Z
dc.date.issued2011
dc.identifier.citationPALEFSKY, 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.issn1533-4406
dc.identifier.urihttps://www.arca.fiocruz.br/handle/icict/9116
dc.language.isoeng
dc.publisherMassachusetts Medical Society
dc.rightsopen access
dc.titleHPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
dc.typeArticle
dc.description.abstractenBACKGROUND: 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, NCT00090285
dc.creator.affilliationUniversity of California at San Francisco. Department of Medicine. San Francisco
dc.creator.affilliationRisk Assessment, Detection. Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL
dc.creator.affilliationMount Sinai School of Medicine. New York
dc.creator.affilliationAssociação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
dc.creator.affilliationUniversity Medical Center. National Public Health Institute. Cuernavaca,
dc.creator.affilliationPrivate Clinic for Infectious Diseases. Berlin
dc.creator.affilliationUniversity of Sydney. Sexually Transmitted Infections Research Centre. Sydney
dc.creator.affilliationMedical College of Georgia. Augusta
dc.creator.affilliationUniversité de Montréal. Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal
dc.creator.affilliationUniversity of Virginia. Charlottesville
dc.creator.affilliationMerck. North Wales, PA
dc.creator.affilliationMerck. North Wales, PA
dc.creator.affilliationMerck. North Wales, PA
dc.creator.affilliationMerck. North Wales, PA
dc.creator.affilliationMerck. North Wales, PA
dc.creator.affilliationMerck. North Wales, PA
dc.subject.decsDoenças do Ânus/prevenção & controle
dc.subject.decsCarcinoma in Situ/prevenção & controle
dc.subject.decsInfecções por Papillomavirus/prevenção & controle
dc.subject.decsVacinas contra Papillomavirus
dc.subject.decsAdolescente
dc.subject.decsAdulto
dc.subject.decsDoenças do Ânus/virologia
dc.subject.decsNeoplasias do Ânus/prevenção & controle
dc.subject.decsNeoplasias do Ânus/virologia
dc.subject.decsCarcinoma in Situ/virologia
dc.subject.decsMétodo Duplo-Cego
dc.subject.decsPapillomavirus Humano 11
dc.subject.decsPapillomavirus Humano 16
dc.subject.decsPapillomavirus Humano 18
dc.subject.decsPapillomavirus Humano 6
dc.subject.decsHumanos
dc.subject.decsMasculino
dc.subject.decsAdulto Jovem
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