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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
- Majewski, S. (author)
- Bosch, F. X. (author)
-
- Dillner, Joakim (author)
- Karolinska Institutet,Lund University,Lunds universitet,Klinisk mikrobiologi, Malmö,Forskargrupper vid Lunds universitet,Clinical Microbiology, Malmö,Lund University Research Groups
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- Iversen, O-E (author)
- Kjaer, S. K. (author)
- Munoz, N. (author)
- Paavonen, J. (author)
- Sigurdsson, K. (author)
- Bryan, J. (author)
- Esser, M. T. (author)
- Giacoletti, K. (author)
- James, M. (author)
- Taddeo, F. (author)
- Vuocolo, S. (author)
- Barr, E. (author)
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- (creator_code:org_t)
- Wiley, 2009
- 2009
- English.
- In: Journal of the European Academy of Dermatology and Venereology. - : Wiley. - 1468-3083 .- 0926-9959. ; 23:10, s. 1147-1155
- Journal article (peer-reviewed)
Abstract
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- 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.
Subject headings
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Dermatologi och venereologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Dermatology and Venereal Diseases (hsv//eng)
Keyword
- virus-like particle vaccine
- HPV
- human papillomavirus
Publication and Content Type
- art (subject category)
- ref (subject category)
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- Majewski, S.
- Bosch, F. X.
- Dillner, Joakim
- Iversen, O-E
- Kjaer, S. K.
- Munoz, N.
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- 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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- Karolinska Institutet
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