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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.; Bosch, F. X.; Dillner, Joakim LU ; Iversen, O-E; Kjaer, S. K.; Munoz, N.; Olsson, S-E; Paavonen, J.; Sigurdsson, K. and Bryan, J., et al. (2009) In Journal of the European Academy of Dermatology and Venereology 23(10). p.1147-1155
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... (More)
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. (Less)
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published
subject
keywords
virus-like particle vaccine, HPV, human papillomavirus
in
Journal of the European Academy of Dermatology and Venereology
volume
23
issue
10
pages
1147 - 1155
publisher
Elsevier
external identifiers
  • wos:000269730400006
  • scopus:70349144516
ISSN
1468-3083
DOI
10.1111/j.1468-3083.2009.03266.x
language
English
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yes
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0f217682-ffee-45f9-8209-955ebb08c6f9 (old id 1492283)
date added to LUP
2009-10-16 17:06:40
date last changed
2017-11-19 03:27:28
@article{0f217682-ffee-45f9-8209-955ebb08c6f9,
  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.},
  author       = {Majewski, S. and Bosch, F. X. and Dillner, Joakim and Iversen, O-E and Kjaer, S. K. and Munoz, N. and Olsson, S-E and Paavonen, J. and Sigurdsson, K. and Bryan, J. and Esser, M. T. and Giacoletti, K. and James, M. and Taddeo, F. and Vuocolo, S. and Barr, E.},
  issn         = {1468-3083},
  keyword      = {virus-like particle vaccine,HPV,human papillomavirus},
  language     = {eng},
  number       = {10},
  pages        = {1147--1155},
  publisher    = {Elsevier},
  series       = {Journal of the European Academy of Dermatology and Venereology},
  title        = {The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24},
  url          = {http://dx.doi.org/10.1111/j.1468-3083.2009.03266.x},
  volume       = {23},
  year         = {2009},
}