Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases.

Abstract

BACKGROUND A phase 3 trial was conducted to evaluate the efficacy of a prophylactic quadrivalent vaccine in preventing anogenital diseases associated with human papillomavirus (HPV) types 6, 11, 16, and 18. METHODS In this randomized, placebo-controlled, double-blind trial involving 5455 women between the ages of 16 and 24 years, we assigned 2723 women to receive vaccine and 2732 to receive placebo at day 1, month 2, and month 6. The coprimary composite end points were the incidence of genital warts, vulvar or vaginal intraepithelial neoplasia, or cancer and the incidence of cervical intraepithelial neoplasia, adenocarcinoma in situ, or cancer associated with HPV type 6, 11, 16, or 18. Data for the primary analysis were collected for a per-protocol susceptible population of women who had no virologic evidence of HPV type 6, 11, 16, or 18 through 1 month after administration of the third dose. RESULTS The women were followed for an average of 3 years after administration of the first dose. In the per-protocol population, those followed for vulvar, vaginal, or perianal disease included 2261 women (83%) in the vaccine group and 2279 (83%) in the placebo group. Those followed for cervical disease included 2241 women (82%) in the vaccine group and 2258 (83%) in the placebo group. Vaccine efficacy was 100% for each of the coprimary end points. In an intention-to-treat analysis, including those with prevalent infection or disease caused by vaccine-type and non-vaccine-type HPV, vaccination reduced the rate of any vulvar or vaginal perianal lesions regardless of the causal HPV type by 34% (95% confidence interval [CI], 15 to 49), and the rate of cervical lesions regardless of the causal HPV type by 20% (95% CI, 8 to 31). CONCLUSIONS The quadrivalent vaccine significantly reduced the incidence of HPV-associated anogenital diseases in young women. (ClinicalTrials.gov number, NCT00092521 [ClinicalTrials.gov].).

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@article{Garland2007QuadrivalentVA, title={Quadrivalent vaccine against human papillomavirus to prevent anogenital diseases.}, author={Suzanne Marie Garland and Mauricio H{\'e}rnandez-Avila and Cosette Marie Wheeler and Gonzalo Perez and Diane Medved Harper and Sepp Leodolter and Grace Tang and Daron Ferris and Marc Steben and Janine T. Bryan and Frank J. Taddeo and Radha A. Railkar and Mark T. Esser and Heather L. Sings and Micki Nelson and John W Boslego and Carlos A Sattler and Eliav Barr and Laura A. Koutsky}, journal={The New England journal of medicine}, year={2007}, volume={356 19}, pages={1928-43} }