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Previous Volume 356:1915-1927 May 10, 2007 Number 19 Next

	Full Text PDF PDA Full Text PowerPoint Slide Set Supplementary Material Perspective by Charo, R. A. Perspective by Agosti, J. M. Editorial by Baden, L. R. Editorial by Sawaya, G. F. Letters Add to Personal Archive Add to Citation Manager Notify a Friend E-mail When Cited E-mail When Letters Appear PubMed Citation

ABSTRACT

Background Human papillomavirus types 16 (HPV-16) and 18 (HPV-18) cause approximately 70% of cervical cancers worldwide. A phase 3 trial was conducted to evaluate a quadrivalent vaccine against HPV types 6, 11, 16, and 18 (HPV-6/11/16/18) for the prevention of high-grade cervical lesions associated with HPV-16 and HPV-18.

Methods In this randomized, double-blind trial, we assigned 12,167 women between the ages of 15 and 26 years to receive three doses of either HPV-6/11/16/18 vaccine or placebo, administered at day 1, month 2, and month 6. The primary analysis was performed for a per-protocol susceptible population that included 5305 women in the vaccine group and 5260 in the placebo group who had no virologic evidence of infection with HPV-16 or HPV-18 through 1 month after the third dose (month 7). The primary composite end point was cervical intraepithelial neoplasia grade 2 or 3, adenocarcinoma in situ, or cervical cancer related to HPV-16 or HPV-18.

Results Subjects were followed for an average of 3 years after receiving the first dose of vaccine or placebo. Vaccine efficacy for the prevention of the primary composite end point was 98% (95.89% confidence interval [CI], 86 to 100) in the per-protocol susceptible population and 44% (95% CI, 26 to 58) in an intention-to-treat population of all women who had undergone randomization (those with or without previous infection). The estimated vaccine efficacy against all high-grade cervical lesions, regardless of causal HPV type, in this intention-to-treat population was 17% (95% CI, 1 to 31).

Conclusions In young women who had not been previously infected with HPV-16 or HPV-18, those in the vaccine group had a significantly lower occurrence of high-grade cervical intraepithelial neoplasia related to HPV-16 or HPV-18 than did those in the placebo group. (ClinicalTrials.gov number, NCT00092534 [ClinicalTrials.gov] .)

Source Information

Address reprint requests to Dr. Laura A. Koutsky at the Department of Epidemiology, University of Washington, Box 359933, Lake Union Place, Suite 300, 1914 N. 34th St., Seattle, WA 98103, or at kouts{at}u.washington.edu.

Full Text of this Article

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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