• S Majewski, F X Bosch, J Dillner, O-E Iversen, S K Kjaer, N Muñoz, S-E Olsson, J Paavonen, K Sigurdsson, J Bryan, M T Esser, K Giacoletti, M James, F Taddeo, S Vuocolo, and E Barr.
• Department of Dermatology and Venereology, Center of Diagnostics and Treatment of Sexually Transmitted Diseases, Medical University of Warsaw, Warsaw, Poland. smajewski@kl.amwaw.edu.pl
• J Eur Acad Dermatol Venereol. 2009 Oct 1; 23 (10): 1147-55.

BackgroundQuadrivalent 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.MethodsFemale 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.ResultsVaccine 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).ConclusionThese 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.

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