A controlled trial of a human papillomavirus type 16 vaccine.

作者: Laura A. Koutsky , Kevin A. Ault , Cosette M. Wheeler , Darron R. Brown , Eliav Barr

DOI: 10.1056/NEJMOA020586

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摘要: 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 HPV-16 infection may provide important public health benefits. Methods In this double-blind study, we randomly assigned 2392 young women (defined as females 23 years age) receive three doses placebo or virus-like–particle (40 μg per dose), given at day 0, month 2, and 6. Genital samples test for DNA were obtained enrollment, one after third vaccination, every six months thereafter. Women referred colposcopy according a protocol. Biopsy tissue was evaluated cervical intraepithelial neoplasia analyzed use polymerase chain reaction. The primary end point persistent infection, defined detection in two more visits. analys...

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