Impact of Human Papillomavirus (HPV)-6/11/16/18 Vaccine on All HPV-Associated Genital Diseases in Young Women

作者：Nubia Muñóz, Susanne K. Kjær, Kristján Sigurðsson, Ole‐Erik Iversen, Mauricio Hernández‐Ávila, Cosette Marie Wheeler, Gonzalo Emanuel Pérez, Darron R. Brown, Laura A. Koutsky, Eng Hseon Tay, Patricia García, Kevin A. Ault, Suzanne Marie Garland, Sepp Leodolter, Sven‐Eric Olsson, Grace Tang, Daron G. Ferris, Jorma A. Paavonen, Marc Steben, Francesc Xavier Bosch, Joakim Dillner, Warner King Huh, Elmar Armin Joura, Robert J. Kurman, Slawomir T. Majewski, Evan R. Myers, LUISA LINA VILLA, Frank J. Taddeo, Christine C. Roberts, Amha Tadesse, Janine T. Bryan, Lisa C. Lupinacci, Katherine E. D. Giacoletti, Heather L. Sings, Margaret K. James, Teresa M. Hesley, Eliav Barr, Richard M. Haupt · 发表于：JNCI Journal of the National Cancer Institute · 年份：2010 · DOI：10.1093/jnci/djp534 · 被引用次数：567 · 研究领域：Cervical Cancer and HPV Research、Reproductive tract infections research、Endometrial and Cervical Cancer Treatments

BACKGROUND: The impact of the prophylactic vaccine against human papillomavirus (HPV) types 6, 11, 16, and 18 (HPV6/11/16/18) on all HPV-associated genital disease was investigated in a population that approximates sexually naive women in that they were "negative to 14 HPV types" and in a mixed population of HPV-exposed and -unexposed women (intention-to-treat group). METHODS: This analysis studied 17 622 women aged 15-26 years who were enrolled in one of two randomized, placebo-controlled, efficacy trials for the HPV6/11/16/18 vaccine (first patient on December 28, 2001, and studies completed July 31, 2007). Vaccine or placebo was given at day 1, month 2, and month 6. All women underwent cervicovaginal sampling and Papanicolaou (Pap) testing at day 1 and every 6-12 months thereafter. Outcomes were any cervical intraepithelial neoplasia; any external anogenital and vaginal lesions; Pap test abnormalities; and procedures such as colposcopy and definitive therapy. Absolute rates are expressed as women with endpoint per 100 person-years at risk. RESULTS: The average follow-up was 3.6 years (maximum of 4.9 years). In the population that was negative to 14 HPV types, vaccination was up to 100% effective in reducing the risk of HPV16/18-related high-grade cervical, vulvar, and vaginal lesions and of HPV6/11-related genital warts. In the intention-to-treat group, vaccination also statistically significantly reduced the risk of any high-grade cervical lesions (19.0% reduction; rate v...