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http://content.nejm.org/cgi/content/short/347/21/1645?query=TOC
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A Controlled Trial of
a Human Papillomavirus Type 16 Vaccine
Laura A. Koutsky, Ph.D., Kevin A. Ault, M.D., Cosette M. Wheeler, Ph.D., Darron R. Brown, M.D., Eliav Barr, M.D., Frances B. Alvarez, R.N., Lisa M. Chiacchierini, Ph.D., Kathrin U. Jansen, Ph.D., for the Proof of Principle Study Investigators
ABSTRACT
Background Approximately 20 percent of adults become infected with human papillomavirus type 16 (HPV-16). Although most infections are benign, some progress to anogenital cancer. A vaccine that reduces the incidence of HPV-16 infection may provide important public health benefits.
Methods In this double-blind study, we randomly assigned 2392 young women (defined as females 16 to 23 years of age) to receive three doses of placebo or HPV-16 virus-like–particle vaccine (40 µg per dose), given at day 0, month 2, and month 6. Genital samples to test for HPV-16 DNA were obtained at enrollment, one month after the third vaccination, and every six months thereafter. Women were referred for colposcopy according to a protocol. Biopsy tissue was evaluated for cervical intraepithelial neoplasia and analyzed for HPV-16 DNA with use of the polymerase chain reaction. The primary end point was persistent HPV-16 infection, defined as the detection of HPV-16 DNA in samples obtained at two or more visits. The primary analysis was limited to women who were negative for HPV-16 DNA and HPV-16 antibodies at enrollment and HPV-16 DNA at month 7.
Results The women were followed for a median of 17.4 months after completing the vaccination regimen. The incidence of persistent HPV-16 infection was 3.8 per 100 woman-years at risk in the placebo group and 0 per 100 woman-years at risk in the vaccine group (100 percent efficacy; 95 percent confidence interval, 90 to 100; P<0.001). All nine cases of HPV-16–related cervical intraepithelial neoplasia occurred among the placebo recipients.
Conclusions Administration of this HPV-16 vaccine reduced the incidence of both HPV-16 infection and HPV-16–related cervical intraepithelial neoplasia. Immunizing HPV-16–negative women may eventually reduce the incidence of cervical cancer.
Source Information
From the Department of Epidemiology, University of Washington, Seattle (L.A.K.); the Department of Obstetrics and Gynecology, University of Iowa, Iowa City (K.A.A.); the Department of Molecular Genetics and Microbiology, University of New Mexico, Albuquerque (C.M.W.); the Department of Medicine, Indiana University School of Medicine, Indianapolis (D.R.B.); Biologics Clinical Research (E.B., F.B.A.) and the Department of Biostatistics (L.M.C.), Merck Research Laboratories, Blue Bell, Pa.; and the Department of Virus and Cell Biology, Merck Research Laboratories, West Point, Pa. (K.U.J.).
Address reprint requests to Dr. Koutsky at the HPV Research Group, 1914 N. 34th St., Suite 300, Seattle, WA 98103, or at kouts@u.washington.edu.
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