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Original Article
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Volume 356:1928-1943 May 10, 2007 Number 19
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Quadrivalent Vaccine against Human Papillomavirus to Prevent Anogenital Diseases
Suzanne M. Garland, M.D., Mauricio Hernandez-Avila, M.D., Cosette M. Wheeler, Ph.D., Gonzalo Perez, M.D., Diane M. Harper, M.D., M.P.H., Sepp Leodolter, M.D., Grace W.K. Tang, M.D., Daron G. Ferris, M.D., Marc Steben, M.D., Janine Bryan, Ph.D., Frank J. Taddeo, Ph.D., Radha Railkar, Ph.D., Mark T. Esser, Ph.D., Heather L. Sings, Ph.D., Micki Nelson, B.S., John Boslego, M.D., Carlos Sattler, M.D., Eliav Barr, M.D., Laura A. Koutsky, Ph.D., for the Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE) I Investigators

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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] .)


Source Information

From the Microbiology and Infectious Diseases Department, Royal Women's Hospital, and the Department of Obstetrics and Gynecology, University of Melbourne, Melbourne, Australia (S.M.G.); the National Institute of Public Health, Cuernavaca, Morelos, Mexico (M.H.-A.); the Departments of Molecular Genetics and Microbiology and Obstetrics and Gynecology, University of New Mexico, Albuquerque (C.M.W.); the National Research Center, Saludcoop, Bogotá, Colombia (G.P.); the Norris Cotton Cancer Center, Lebanon, NH (D.M.H.); the Departments of Obstetrics and Gynecology and Community and Family Medicine, Dartmouth Medical School, Hanover, NH (D.M.H.); the Department of Gynecology and Obstetrics, Women's Health Clinic, Medical University of Vienna, Vienna (S.L.); the Department of Obstetrics and Gynecology, University of Hong Kong, Hong Kong (G.W.K.T.); the Department of Family Medicine and Obstetrics and Gynecology, Medical College of Georgia, Augusta (D.G.F.); the Direction Risques Biologiques, Environnementaux et Occupationnels, Institut National de Santé Publique du Québec, Montreal (M.S.); Merck Research Laboratories, West Point, PA (J. Bryan, F.J.T., R.R., M.T.E., H.L.S., M.N., J. Boslego, C.S., E.B.); and the Department of Epidemiology, University of Washington, Seattle (L.A.K.).

Address reprint requests to Dr. Garland at the Microbiology and Infectious Diseases Department, Royal Women's Hospital, 132 Grattan St., Carlton, Victoria 3053, Australia, or at suzanne.garland{at}rch.org.au.

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Related Letters:

Human Papillomavirus Vaccine
Miller N. B., Raychaudhuri G., Toerner J. G., Suba E. J., Raab S. S., the Viet/American Cervical Cancer Prevention Project , Garland S. G., Koutsky L. A., Sawaya G. F., Smith-McCune K., Agosti J. M., Goldie S. J.
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N Engl J Med 2007; 357:1154-1156, Sep 13, 2007. Correspondence

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