Safety and immunogenicity of a vaccine targeting human papillomavirus types 6, 11, 16 and 18: A randomized, double-blind, placebo-controlled trial in Chinese males and females

被引：52

作者：

Li, Rongcheng ^{[1
]}

Li, Yanping ^{[1
]}

Radley, David ^{[2
]}

Liu, Youping ^{[3
]}

Huang, Teng ^{[1
]}

Sings, Heather L. ^{[2
]}

Zhang, Lingling ^{[4
]}

Wang, Wei ^{[4
]}

Zhong, Xiang ^{[4
]}

Saah, Alfred J. ^{[2
]}

机构：

[1] Guangxi Ctr Dis Prevent & Control, Nanning 530028, Guangxi, Peoples R China

[2] Merck Sharp & Dohme Corp, Whitehouse Stn, NJ 08889 USA

[3] Wuzhou Ctr Dis Prevent & Control, Wuzhou 543002, Guangxi, Peoples R China

[4] Hangzhou MSD Pharmaceut Co Ltd, Shanghai 200040, Peoples R China

来源：

VACCINE | 2012年 / 30卷 / 28期

关键词：

Cervical cancer; Human papillomavirus; Prevention; Randomized trial; Vaccine; PARTICLE VACCINE; YOUNG-WOMEN; HPV; EFFICACY; INFECTION; IMPACT;

D O I：

10.1016/j.vaccine.2012.02.079

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

In this randomized, double-blind, placebo-controlled trial, 9-15 year old Chinese males (n = 100) and 9-45 year old Chinese females (n = 500) from Wuzhou, Guangxi, China were randomized (1:1) to receive either quadrivalent HPV vaccine or adjuvant-containing placebo. Blood samples were obtained at day 1 and one month post-dose 3 to determine the level of vaccine-induced antibodies. Among vaccine recipients, high antibody levels were observed for each of the four HPV types and seroconversion was >96%. The vaccine was generally well tolerated, with no vaccine-related serious adverse events. This study demonstrated that the quadrivalent HPV vaccine is highly immunogenic and generally well tolerated among Chinese males and females. (C) 2012 Elsevier Ltd. All rights reserved.

引用

页码：4284 / 4291

页数：8

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