Enterovirus 71 (EV71) infections, which can cause severe complications, have become one of the serious public health issues in the Western Pacific region and China. To date, a number of pharmaceutical companies and institutes have initiated the research and development of EV71 vaccines as a countermeasure. As is the case with innovative vaccine development, there are several critical bottlenecks in EV71 vaccine development that must be overcome before the clinical trials, including the selection of vaccine strain, standardization of the procedure for quantifying neutralizing antibody (NTAb) and antigen, establishment and application of a reference standard and biological standards, development of animal models for the evaluation of protective efficacy, and identification of the target patient population. To tackle these technical obstacles, researchers in Mainland of China have conducted a series of studies concerning the screening of vaccine strains and the establishment of criteria, biological standards and detection methods, thereby advancing EV71 vaccine development. This review summarizes recent worldwide progress on the quality control and evaluation of EV71 vaccines.
Corresponding Author(s):
Wang Junzhi,Email:wangjz@nicpbp.org.cn
引用本文:
. Progress on the research and development of human enterovirus 71 (EV71) vaccines[J]. Frontiers of Medicine, 0, (): 111-121.
Zhenglun Liang, Qunying Mao, Fan Gao, Junzhi Wang. Progress on the research and development of human enterovirus 71 (EV71) vaccines. Front Med, 0, (): 111-121.
National Health Research Institutes, Taiwan, China [37]
B4
Vero
Roller bottle, inactivation
Phase I clinical trial
NCT01268787
5
Invitrogen Pte. Ltd., Singapore [2]
–
–
–, inactivation
Phase I clinical trial
NCT01376479
6
Adimmune, Taiwan, China [2]
–
Vero
Bioreactor, inactivation
Preclinical phase
–
7
Beijing Luzhu Biopharmaceutical Co., Ltd., etc.
C4
Vero
–, inactivation
Preclinical phase
–
Tab.2
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