Randomized-controlled phase II clinical trial of a bacterially expressed recombinant hepatitis E vaccine

被引：111

作者：

Zhang, Jun ^{[1
]}

Liu, Chong-bo ^{[2
]}

Li, Rong-cheng ^{[3
]}

Li, Yi-min ^{[4
]}

Zheng, Ying-jie ^{[5
]}

Li, Yan-ping ^{[3
]}

Luo, Dong ^{[3
]}

Pan, Bai-bin ^{[3
]}

Nong, Yi ^{[3
]}

Ge, Sheng-Xiang ^{[1
]}

Xiong, Jun-hui ^{[1
]}

Shih, James Wai-kuo ^{[1
]}

Ng, Mun-Hon ^{[1
]}

Xia, Ning-shao ^{[1
]}

机构：

[1] Xiamen Univ, Natl Inst Diagnost & Vaccine Dev Infect Dis, Xiamen 361005, Peoples R China

[2] Chinese Ctr Dis Control & Prevent, Inst Viral Dis Control & Prevent, Beijing, Peoples R China

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

[4] Beijing Wantal Biol Pharm Enterprise Co Ltd, Beijing, Peoples R China

[5] Fudan Univ, Sch Publ Hlth, Shanghai 200433, Peoples R China

来源：

VACCINE | 2009年 / 27卷 / 12期

关键词：

Hepatitis E; HEV; HEV vaccine; Clinical trial; VIRUS CAPSID PROTEIN; NON-B HEPATITIS; WILD BOAR; NON-A; SWINE; IMMUNOGENICITY; SEQUENCES; TRANSMISSION; ANTIGENICITY; PREGNANCY;

D O I：

10.1016/j.vaccine.2008.12.061

中图分类号：

R392 [医学免疫学]; Q939.91 [免疫学];

学科分类号：

100102 ;

摘要：

The candidate recombinant hepatitis E vaccine, HEV 239, protect monkeys against infection by hepatitis F. virus (HEV). The safety and immunogenicity of the vaccine for humans was assessed in a randomized controlled phase II clinical trial. The study was conducted in an endemic area of southern China and consisted of a dose scheduling, involving 457 adults and a dose escalation component involving 155 high school students. The results showed that the vaccine is safe and immunogenic for humans and suggest that it could prevent new HEV infection. (C) 2009 Elsevier Ltd. All rights reserved.

引用

页码：1869 / 1874

页数：6

共 26 条

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