A controlled trial of a human papillomavirus type 16 vaccine.

@article{citeulike:972159, 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 microg 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.}, address = {Department of Epidemiology, University of Washington, Seattle, USA. kouts@u.washington.edu}, author = {Koutsky, L. A. and Ault, K. A. and Wheeler, C. M. and Brown, D. R. and Barr, E. and Alvarez, F. B. and Chiacchierini, L. M. and Jansen, K. U. and }, citeulike-article-id = {972159}, doi = {http://dx.doi.org/10.1056/NEJMoa020586}, issn = {1533-4406}, journal = {N Engl J Med}, keywords = {wh}, month = {November}, number = {21}, pages = {1645--1651}, posted-at = {2008-07-18 02:19:23}, priority = {2}, title = {A controlled trial of a human papillomavirus type 16 vaccine.}, url = {http://dx.doi.org/10.1056/NEJMoa020586}, volume = {347}, year = {2002} }

TY - JOUR ID - citeulike:972159 L3 - citeulike-article-id:972159 TI - A controlled trial of a human papillomavirus type 16 vaccine. JF - N Engl J Med VL - 347 IS - 21 SP - 1645 EP - 1651 AD - Department of Epidemiology, University of Washington, Seattle, USA. kouts@u.washington.edu SN - 1533-4406 N2 - 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 microg 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. KW - wh AU - Koutsky, LA AU - Ault, KA AU - Wheeler, CM AU - Brown, DR AU - Barr, E AU - Alvarez, FB AU - Chiacchierini, LM AU - Jansen, KU PY - 2002/11/21/ UR - http://dx.doi.org/10.1056/NEJMoa020586 ER -