The impact of a quadrivalent human papillomavirus (types 6, 11, 16, 18) virus-like particle vaccine in European women aged 16 to 24.

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.

• Authors: 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, E Barr
• Journal: Journal of the European Academy of Dermatology and Venereology : JEADV (J Eur Acad Dermatol Venereol) Vol. 23 Issue 10 Pg. 1147-55 (Oct 2009) ISSN: 1468-3083 [Electronic] England
• PMID: 19453788 (Publication Type: Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
• Papillomavirus Vaccines
• Placebos

Topics

• Adenocarcinoma (prevention & control)
• Adolescent
• Adult
• Female
• Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18
• Humans
• Papillomavirus Vaccines (administration & dosage)
• Placebos
• Randomized Controlled Trials as Topic
• Sexual Partners
• Uterine Cervical Neoplasms (prevention & control)
• Young Adult
• Uterine Cervical Dysplasia (prevention & control)