综述

肠道病毒71型全病毒灭活疫苗临床研究进展

  • 林惠娟 王一平 毛群颖 周旭 梁争论
展开
  • 100050 北京,中国食品药品检定研究院肝炎病毒疫苗室(林惠娟、王一平、毛群颖、梁争论);200052上海生物制品研究所有限责任公司研发部(林惠娟),总经理办公室(周旭)

网络出版日期: 2025-08-16

基金资助

国家“十二五”科技重大专项课题(2012ZX10004701)

Progress in clinical research of inactivated enterovirus 71 whole-virus vaccines

Expand
  • *Division of Hepatitis Virus Vaccines, National Institutes for Food and Drug Control, Beijing 100050,China;*R&D Department, Shanghai Institute of Biological Products Co., Ltd., Shanghai 200052, China

Online published: 2025-08-16

摘要

 肠道病毒71型(enterovirus 71,EV71)是引起严重手足口病的主要病原体,研发安全有效的疫苗是控制手足口病的关键措施。目前我国(香港、澳门和台湾地区除外)已有3家公司完成了EV71全病毒灭活疫苗的Ⅲ期临床试验,结果显示疫苗在婴幼儿中安全性良好,预防EV71引起手足口病的保护率达到90%以上,预防EV71其他相关疾病的保护率达到80%以上。此文对这些EV71疫苗临床试验情况做一综述。

本文引用格式

林惠娟 王一平 毛群颖 周旭 梁争论 . 肠道病毒71型全病毒灭活疫苗临床研究进展[J]. 国际生物制品学杂志, 2015 , 38(1) : 22 -26 . DOI: 10.3760/cma.j.issn.1673-4211.2015.01.006

Abstract

 Enterovious 71(EV71) is a major pathogen causing severe hand, foot and mouth disease (HFMD). A safe and effective vaccine against EV71 is the critical approach to control the disease. Currently, three companies in China (excluding Hong Kong, Macao and Taiwan) have completed Phase Ⅲ clinical trials of inactivated EV71 whole-virus vaccines. Results of the clinical trials indicate high safety and immunogenicity of EV71 vaccine. Protective efficacies against EV71-associated HFMD and other EV71-associated diseases are over 90% and 80%, respectively. In this paper, the clinical trials of EV71 vaccines are summarized.
文章导航

/