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The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24 |
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| Authors: | S Majewski ,FX Bosch,J. Dillner,O-E Iversen,SK Kjaer,N Muñ oz,S-E Olsson,J Paavonen,K Sigurdsson,J Bryan,MT Esser,K Giacoletti,M James,F Taddeo,S Vuocolo,E Barr |
| Affiliation: | Department of Dermatology and Venereology, Center of Diagnostics and Treatment of Sexually Transmitted Diseases, Medical University of Warsaw, Warsaw, Poland; Institut Catala d'Oncologia, Epidemiology and Cancer Registration Unit, L'Hospitalet de Llobregat, Barcelona, Spain; Department of Medical Microbiology, Lund University, Lund, Sweden; Institute of Clinical Medicine, University of Bergen and Department of Obstetrics and Gynecology, Haukeland University Hospital, Norway; Department of Virus, Hormones and Cancer, Institute of Cancer Epidemiology, Danish Cancer Society/Rigshospitalet, Copenhagen, Denmark; National Institute of Cancer, Bogotá, Colombia; Karolinska Institute at Danderyd Hospital, Stockholm, Sweden; Department of Obstetrics and Gynecology, University of Helsinki, Helsinki, Finland; National Cancer Detection Clinic, Icelandic Cancer Society, Reykjavik, Iceland; Merck &Co., Inc., West Point, PA, USA |
| Abstract: | 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 |
| Keywords: | HPV human papillomavirus virus-like particle vaccine |