Author | Palefsky, Joel M | |
Author | Giuliano, Anna R | |
Author | Goldstone, Stephen | |
Author | Moreira Júnior, Edson Duarte | |
Author | Aranda, Carlos | |
Author | Jessen, Heiko | |
Author | Hillman, Richard J | |
Author | Ferris, Daron G | |
Author | Coutlee, Francois | |
Author | Stoler, Mark H | |
Author | Marshall, J. Brooke | |
Author | Radley, David | |
Author | Vuocolo, Scott | |
Author | Haupt, Richard M | |
Author | Guris, Dalya | |
Author | Garner, Elizabeth I. O | |
Access date | 2014-12-05T19:21:07Z | |
Available date | 2014-12-05T19:21:07Z | |
Document date | 2011 | |
Citation | 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. | pt_BR |
ISSN | 1533-4406 | |
URI | https://www.arca.fiocruz.br/handle/icict/9116 | |
Language | eng | pt_BR |
Publisher | Massachusetts Medical Society | pt_BR |
Rights | open access | pt_BR |
Title | HPV vaccine against anal HPV infection and anal intraepithelial neoplasia. | pt_BR |
Type | Article | pt_BR |
Abstract | BACKGROUND: 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 | pt_BR |
Affilliation | University of California at San Francisco. Department of Medicine. San Francisco | pt_BR |
Affilliation | Risk Assessment, Detection. Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL | 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 | University Medical Center. National Public Health Institute. Cuernavaca, | pt_BR |
Affilliation | Private Clinic for Infectious Diseases. Berlin | pt_BR |
Affilliation | University of Sydney. Sexually Transmitted Infections Research Centre. Sydney | pt_BR |
Affilliation | Medical College of Georgia. Augusta | pt_BR |
Affilliation | Université de Montréal. Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal | pt_BR |
Affilliation | University of Virginia. Charlottesville | pt_BR |
Affilliation | Merck. North Wales, PA | pt_BR |
Affilliation | Merck. North Wales, PA | pt_BR |
Affilliation | Merck. North Wales, PA | pt_BR |
Affilliation | Merck. North Wales, PA | pt_BR |
Affilliation | Merck. North Wales, PA | pt_BR |
Affilliation | Merck. North Wales, PA | pt_BR |
DeCS | Doenças do Ânus/prevenção & controle | pt_BR |
DeCS | Carcinoma in Situ/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 | Doenças do Ânus/virologia | pt_BR |
DeCS | Neoplasias do Ânus/prevenção & controle | pt_BR |
DeCS | Neoplasias do Ânus/virologia | pt_BR |
DeCS | Carcinoma in Situ/virologia | pt_BR |
DeCS | Método Duplo-Cego | pt_BR |
DeCS | Papillomavirus Humano 11 | pt_BR |
DeCS | Papillomavirus Humano 16 | pt_BR |
DeCS | Papillomavirus Humano 18 | pt_BR |
DeCS | Papillomavirus Humano 6 | pt_BR |
DeCS | Humanos | pt_BR |
DeCS | Masculino | pt_BR |
DeCS | Adulto Jovem | pt_BR |