A controlled trial of a human papillomavirus type 16 vaccine

Laura A. Koutsky, Kevin A. Ault, Cosette M. Wheeler, Darron R. Brown, Eliav Barr, Frances B. Alvarez, Lisa M. Chiacchierini, Kathrin U. Jansen

Research output: Contribution to journalArticle

1508 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)1645-1651
Number of pages7
JournalNew England Journal of Medicine
Issue number21
StatePublished - Nov 21 2002

ASJC Scopus subject areas

  • Medicine(all)

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    Koutsky, L. A., Ault, K. A., Wheeler, C. M., Brown, D. R., Barr, E., Alvarez, F. B., Chiacchierini, L. M., & Jansen, K. U. (2002). A controlled trial of a human papillomavirus type 16 vaccine. New England Journal of Medicine, 347(21), 1645-1651. https://doi.org/10.1056/NEJMoa020586