| Autor: |
Majewski, S., Bosch, F. X., Dillner, J., Iversen, O.-E., Kjaer, S. K., Muñoz, N., Olsson, S.-E., Paavonen, J., Sigurdsson, K., Bryan, J., Esser, M. T., Giacoletti, K., James, M., Taddeo, F., Vuocolo, S., Barr, E. |
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| Zdroj: |
Journal of the European Academy of Dermatology & Venereology; Oct2009, Vol. 23 Issue 10, p1147-1155, 9p, 6 Charts, 1 Graph |
| Abstrakt: |
Background Quadrivalent human papillomavirus (HPV types 6/11/16/18) L1 VLP vaccine is highly effective in preventing HPV 6/11/16/18-related cervical and external genital disease. Herein, we evaluated the impact of the quadrivalent HPV 6/11/16/18 L1 VLP vaccine on prevention of HPV-associated cervico-genital lesions in a broad population of sexually active European women. Methods Female subjects ( N = 9265) aged 16–24 with four or fewer lifetime sexual partners were enrolled and randomized to quadrivalent HPV vaccine or placebo. Subjects underwent cervicovaginal sampling for HPV DNA detection. Papanicolaou testing and anti-HPV 6/11/16/18 serology testing was also performed. Results Vaccine efficacy against lesions representing immediate cervical cancer precursors (cervical intraepithelial neoplasia grade 2/3 or adenocarcinoma in situ) related to HPV 6/11/16/18 in the per-protocol population was 100.0%[95% confidence interval (95% CI), 89.8–100.0]. Efficacy against external genital lesions (vulvar or vaginal intraepithelial neoplasia, condyloma, vulvar or vaginal cancer) related to vaccine HPV types in the per-protocol European population was 99.0% (95% CI, 94.4–100.0). Conclusion These data demonstrate that quadrivalent HPV 6/11/16/18 vaccination programs in 16- to 24-year-old European women can be beneficial. NCT0009252, NCT00092534, NCT00092495 [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
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