新型戊型肝炎疫苗的研制。
Development of new hepatitis E vaccines.
机构信息
a College of Veterinary Medicine, Jilin University , Changchun , Jilin , PR China.
b Changchun Institute of Biological Products Co. Ltd. , Changchun , Jilin , PR China.
出版信息
Hum Vaccin Immunother. 2018;14(9):2254-2262. doi: 10.1080/21645515.2018.1469591. Epub 2018 Jun 18.
Abstract
Hepatitis E virus (HEV) infection is an emerging zoonotic disease posing a severe threat to public health in the world, especially to pregnant women. Currently, no specific treatments are available for HEV infection. Therefore, it is crucial to develop vaccine to prevent this infection. Although several potential candidate vaccines against HEV have been studied for their immunogenicity and efficacy, only Hecolin® which is developed by Xiamen Innovax Biotech Co., Ltd. and approved by China Food and Drug Administration (CFDA) in 2012, is the licensed HEV vaccine in the world so far. Extensive studies on safety, immunogenicity and efficacy in phase III clinical trials have shown that Hecolin® is a promising vaccine for HEV prevention and control. In this article, the advances on HEV vaccine development and research are briefly reviewed.
摘要
戊型肝炎病毒（HEV）感染是一种新兴的人畜共患病，对全球公共卫生构成严重威胁，尤其对孕妇而言。目前，尚无针对 HEV 感染的特效治疗方法。因此，开发疫苗预防这种感染至关重要。尽管已经研究了几种针对 HEV 的潜在候选疫苗以评估其免疫原性和有效性，但截至目前，仅有厦门万泰沧海生物技术有限公司研发的、并于 2012 年获得中国国家食品药品监督管理总局（CFDA）批准的海克欣®是世界上获得许可的 HEV 疫苗。III 期临床试验中的安全性、免疫原性和有效性的广泛研究表明，海克欣®是一种有前途的 HEV 预防控制疫苗。本文简要综述了 HEV 疫苗的开发和研究进展。
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