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
Methods In this double-blind study, we randomly assigned 2392young women (defined as females 16 to 23 years of age) to receivethree 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 monthsthereafter. Women were referred for colposcopy according toa protocol. Biopsy tissue was evaluated for cervical intraepithelialneoplasia and analyzed for HPV-16 DNA with use of the polymerasechain reaction. The primary end point was persistent HPV-16infection, defined as the detection of HPV-16 DNA in samplesobtained at two or more visits. The primary analysis was limitedto women who were negative for HPV-16 DNA and HPV-16 antibodiesat enrollment and HPV-16 DNA at month 7.
Results The women were followed for a median of 17.4 monthsafter completing the vaccination regimen. The incidence of persistentHPV-16 infection was 3.8 per 100 woman-years at risk in theplacebo group and 0 per 100 woman-years at risk in the vaccinegroup (100 percent efficacy; 95 percent confidence interval,90 to 100; P<0.001). All nine cases of HPV-16–relatedcervical intraepithelial neoplasia occurred among the placeborecipients.
Conclusions Administration of this HPV-16 vaccine reduced theincidence of both HPV-16 infection and HPV-16–relatedcervical intraepithelial neoplasia. Immunizing HPV-16–negativewomen 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{at}u.washington.edu.
A Human Papillomavirus Type 16 Vaccine
Duggirala M. K., Cuddihy M.-T., Tammela J. E., Lele S., Odunsi K., Schrag S. J., Schuchat A., Schulkin J., Gambacorti C. B., Yoo S. S., Whitmore S. E., Koutsky L. A., Stanberry L. R.
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N Engl J Med 2003;
348:1402-1405, Apr 3, 2003.
Correspondence
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