HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.

dc.creatorPalefsky, Joel M
dc.creatorGiuliano, Anna R
dc.creatorGoldstone, Stephen
dc.creatorMoreira Júnior, Edson Duarte
dc.creatorAranda, Carlos
dc.creatorJessen, Heiko
dc.creatorHillman, Richard J
dc.creatorFerris, Daron G
dc.creatorCoutlee, Francois
dc.creatorStoler, Mark H
dc.creatorMarshall, J. Brooke
dc.creatorRadley, David
dc.creatorVuocolo, Scott
dc.creatorHaupt, Richard M
dc.creatorGuris, Dalya
dc.creatorGarner, Elizabeth I. O
dc.date2014-12-05T19:21:07Z
dc.date2014-12-05T19:21:07Z
dc.date2011
dc.date.accessioned2023-09-27T00:10:49Z
dc.date.available2023-09-27T00:10:49Z
dc.identifierPALEFSKY, 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.identifier1533-4406
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/9116
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8898243
dc.descriptionBACKGROUND: 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.formatapplication/pdf
dc.languageeng
dc.publisherMassachusetts Medical Society
dc.rightsopen access
dc.subjectDoenças do Ânus/prevenção & controle
dc.subjectCarcinoma in Situ/prevenção & controle
dc.subjectInfecções por Papillomavirus/prevenção & controle
dc.subjectVacinas contra Papillomavirus
dc.subjectAdolescente
dc.subjectAdulto
dc.subjectDoenças do Ânus/virologia
dc.subjectNeoplasias do Ânus/prevenção & controle
dc.subjectNeoplasias do Ânus/virologia
dc.subjectCarcinoma in Situ/virologia
dc.subjectMétodo Duplo-Cego
dc.subjectPapillomavirus Humano 11
dc.subjectPapillomavirus Humano 16
dc.subjectPapillomavirus Humano 18
dc.subjectPapillomavirus Humano 6
dc.subjectHumanos
dc.subjectMasculino
dc.subjectAdulto Jovem
dc.titleHPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
dc.typeArticle


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