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

被引：26

作者：

Majewski, S. ^{[1
]}

Bosch, F. X. ^{[2
]}

Dillner, J. ^{[3
]}

Iversen, O-E ^{[4
,5
]}

Kjaer, S. K. ^{[6
]}

Munoz, N. ^{[7
]}

Olsson, S-E ^{[8
]}

Paavonen, J. ^{[9
]}

Sigurdsson, K. ^{[10
]}

Bryan, J. ^{[11
]}

Esser, M. T. ^{[11
]}

Giacoletti, K. ^{[11
]}

James, M. ^{[11
]}

Taddeo, F. ^{[11
]}

Vuocolo, S. ^{[11
]}

Barr, E. ^{[11
]}

机构：

[1] Med Univ Warsaw, Dept Dermatol & Venereol, Ctr Diagnost & Treatment Sexually Transmitted Dis, Warsaw, Poland

[2] Inst Catala Oncol, Epidemiol & Canc Registrat Unit, Barcelona, Spain

[3] Lund Univ, Dept Med Microbiol, Lund, Sweden

[4] Haukeland Hosp, Dept Obstet & Gynecol, Haukeland, Norway

[5] Univ Bergen, Inst Clin Med, N-5020 Bergen, Norway

[6] Rigshosp, Danish Canc Soc, Inst Canc Epidemiol, Dept Virus Hormones & Canc, DK-2100 Copenhagen, Denmark

[7] Natl Canc Inst, Bogota, Colombia

[8] Danderyd Hosp, Karolinska Inst, Stockholm, Sweden

[9] Univ Helsinki, Dept Obstet & Gynecol, Helsinki, Finland

[10] Iceland Canc Soc, Natl Canc Detect Clin, Reykjavik, Iceland

[11] Merck & Co Inc, West Point, PA USA

来源：

JOURNAL OF THE EUROPEAN ACADEMY OF DERMATOLOGY AND VENEREOLOGY | 2009年 / 23卷 / 10期

关键词：

HPV; human papillomavirus; virus-like particle vaccine; GRADE CERVICAL LESIONS; INTRAEPITHELIAL NEOPLASIA; GENOTYPE DISTRIBUTION; HPV TYPES; CANCER; PREVALENCE; VULVAR; IMMUNOGENICITY; POPULATION; EFFICACY;

D O I：

10.1111/j.1468-3083.2009.03266.x

中图分类号：

R75 [皮肤病学与性病学];

学科分类号：

100206 ;

摘要：

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.

引用

页码：1147 / 1155

页数：9

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