BACKGROUND: A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95%-100% effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with > or =1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types. METHODS: Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccineenrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed. RESULTS: Vaccination was 100% effective (95% confidence interval [CI], 79%-100%) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94% (95% CI, 81%-99%). CONCLUSIONS: Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening.
RCT Entities:
BACKGROUND: A quadrivalent (types 6, 11, 16, and 18) human papillomavirus (HPV) L1 virus-like-particle (VLP) vaccine has been shown to be 95%-100% effective in preventing cervical and genital disease related to HPV-6, -11, -16, and -18 in 16-26-year-old women naive for HPV vaccine types. Because most women in the general population are sexually active, some will have already been infected with > or =1 HPV vaccine types at the time vaccination is offered. Here, we assessed whether such infected women are protected against disease caused by the remaining HPV vaccine types. METHODS: Two randomized, placebo-controlled trials of the quadrivalent (types 6, 11, 16, and 18) HPV vaccine enrolled 17,622 women without consideration of baseline HPV status. Among women infected with 1-3 HPV vaccine types at enrollment, efficacy against genital disease related to the HPV vaccine type or types for which subjects were naive was assessed. RESULTS: Vaccination was 100% effective (95% confidence interval [CI], 79%-100%) in preventing incident cervical intraepithelial neoplasia 2 or 3 or cervical adenocarcinoma in situ caused by the HPV type or types for which the women were negative at enrollment. Efficacy for preventing vulvar or vaginal HPV-related lesions was 94% (95% CI, 81%-99%). CONCLUSIONS: Among women positive for 1-3 HPV vaccine types before vaccination, the quadrivalent HPV vaccine protected against neoplasia caused by the remaining types. These results support vaccination of the general population without prescreening.
Authors: Debbie Saslow; Diane Solomon; Herschel W Lawson; Maureen Killackey; Shalini L Kulasingam; Joanna Cain; Francisco A R Garcia; Ann T Moriarty; Alan G Waxman; David C Wilbur; Nicolas Wentzensen; Levi S Downs; Mark Spitzer; Anna-Barbara Moscicki; Eduardo L Franco; Mark H Stoler; Mark Schiffman; Philip E Castle; Evan R Myers Journal: CA Cancer J Clin Date: 2012-03-14 Impact factor: 508.702
Authors: Antonia Radaelli; Eleana Pozzi; Sole Pacchioni; Carlo Zanotto; Carlo De Giuli Morghen Journal: J Transl Med Date: 2010-04-21 Impact factor: 5.531
Authors: Joakim Dillner; Susanne K Kjaer; Cosette M Wheeler; Kristján Sigurdsson; Ole-Erik Iversen; Mauricio Hernandez-Avila; Gonzalo Perez; Darron R Brown; Laura A Koutsky; Eng Hseon Tay; Patricia García; Kevin A Ault; Suzanne M Garland; Sepp Leodolter; Sven-Eric Olsson; Grace W K Tang; Daron G Ferris; Jorma Paavonen; Matti Lehtinen; Marc Steben; F Xavier Bosch; Elmar A Joura; Slawomir Majewski; Nubia Muñoz; Evan R Myers; Luisa L Villa; Frank J Taddeo; Christine Roberts; Amha Tadesse; Janine T Bryan; Roger Maansson; Shuang Lu; Scott Vuocolo; Teresa M Hesley; Eliav Barr; Richard Haupt Journal: BMJ Date: 2010-07-20