Clinical trial experience with prophylactic HPV 6/11/16/18 VLP vaccine in young women from the Asia-Pacific region

被引：27

作者：

Tay, E. H. ^{[1
]}

Garland, S. ^{[2
]}

Tang, G. ^{[3
]}

Nolan, T. ^{[4
,5
]}

Huang, L. -M. ^{[6
]}

Orloski, L. ^{[7
]}

Lu, S. ^{[7
]}

Barr, E. ^{[7
]}

机构：

[1] KK Womens & Childrens Hosp, Singapore 229899, Singapore

[2] Univ Melbourne, Dept Obstet & Gynecol, Melbourne, Vic 3010, Australia

[3] Univ Hong Kong, Dept Obstet & Gynecol, Hong Kong, Hong Kong, Peoples R China

[4] Murdoch Childrens Res Inst, Murdoch, WA, Australia

[5] Univ Melbourne, Sch Populat Hlth, Melbourne, Vic 3010, Australia

[6] Natl Taiwan Univ Hosp, Taipei, Taiwan

[7] Merck Res Labs, West Point, PA USA

来源：

INTERNATIONAL JOURNAL OF GYNECOLOGY & OBSTETRICS | 2008年 / 102卷 / 03期

关键词：

cervical cancer; cervical intraepithelial neoplasia; clinical trial; genital warts; human papillomavirus; prophylactic vaccine;

D O I：

10.1016/j.ijgo.2008.03.021

中图分类号：

R71 [妇产科学];

学科分类号：

100211 ;

摘要：

Objective:To evaluate results of three phase 3 clinical trials of quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women. Methods:A total of 814 women from the Asia-Pacific region (aged 16 to 26 years) received vaccine or placebo in 1 of 3 protocols. Descriptive analyses focused on the efficacy, safety, and immunogenicity of the vaccine and the natural history of HPV disease. Results:Vaccine efficacy against disease caused by HPV types 6, 11, 16, or 18 was 100% for cervical intraepithelial neoplasia (0 vs 12 cases; 95% confidence interval [CI], 63.1%-100%) and 100% for vulvar and vaginal intraepithelial neoplasia or condylomata accuminata (0 vs 5 cases; 95% CI, -11.8% to 100%). The vaccination was highly immunogenic. Vaccine recipients experienced a significantly higher injection site adverse event rate (P=0.002). Compared with other world regions, lower rates of smoking and baseline positivity to 14 HPV types (including the vaccine types) were observed among Asia-Pacific participants. Conclusion: Prophylactic quadrivalent HPV 6/11/16/18 vaccination of young Asia-Pacific women demonstrated high efficacy, safety, and tolerability. Together with an observed low baseline HPV positivity rate, the Asia-pacific population is potentially an important cohort to benefit from vaccination. (c) 2008 International Federation of Gynecology and Obstetrics. Published by Elsevier Ireland Ltd. All rights reserved.

引用

页码：275 / 283

页数：9

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