Please use this identifier to cite or link to this item: https://www.arca.fiocruz.br/handle/icict/9116
Title: HPV vaccine against anal HPV infection and anal intraepithelial neoplasia.
Authors: 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
Affilliation: University of California at San Francisco. Department of Medicine. San Francisco
Risk Assessment, Detection. Intervention Program, H. Lee Moffitt Cancer Center and Research Institute. Tampa, FL
Mount Sinai School of Medicine. New York
Associação Obras Sociais Irmã Dulce. Salvador, BA, Brasil / Fundação Oswaldo Cruz. Centro de Pesquisas Gonçalo Moniz. Salvador, BA, Brasil
University Medical Center. National Public Health Institute. Cuernavaca,
Private Clinic for Infectious Diseases. Berlin
University of Sydney. Sexually Transmitted Infections Research Centre. Sydney
Medical College of Georgia. Augusta
Université de Montréal. Centre de Recherche du Centre Hospitalier de l’Université de Montréal. Montreal
University of Virginia. Charlottesville
Merck. North Wales, PA
Merck. North Wales, PA
Merck. North Wales, PA
Merck. North Wales, PA
Merck. North Wales, PA
Merck. North Wales, PA
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
DeCS: 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
Issue Date: 2011
Publisher: Massachusetts Medical Society
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.
ISSN: 1533-4406
Copyright: open access
Appears in Collections:BA - IGM - Artigos de Periódicos

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