title: Progress on the research and development of inactivated EV71 whole-virus vaccines.
abstract: The prevalence of diseases caused by EV71 infection has become a serious public health problem in the Western Pacific region. Due to a lack of effective treatment options, controlling EV71 epidemics has mainly focused on the research and development (R&D) of EV71 vaccines. Thus far, five organizations have completed pre-clinical studies focused on the development of inactivated EV71 whole-virus vaccines, including vaccine strain screening, process optimization, safety and immunogenicity evaluation, and are in different stages of clinical trials. Among these organizations, three companies in Mainland China [Beijing Vigoo Biological Co., Ltd. (Vigoo), Sinovac Biotech Ltd. (Sinovac) and Institute of Medical Biology, Chinese Academy of Medical Science (CAMS)] have recently completed Phase III trials for the vaccines they developed. In addition, the other two vaccines, developed by National Health Research Institutes (NHRI) of Taiwan and Inviragen Pte., Ltd (Inviragen), of Singapore, have also completed Phase I clinical trials. Published clinical trial results indicate that the inactivated EV71 vaccines have good safety and immunogenicity in the target population (infants) and confer a relatively high rate of protection against EV71 infection-related diseases. The results of clinical trials suggest a promising future for the clinical use of EV71 vaccines. Here, we review and highlight the recent progress on the R&D of inactivated EV71 whole-virus vaccines.
authors.affiliation: National Institutes for Food and Drug Control; Beijing, P.R. China.
authors.forename: Zheng-Lun
authors.initials: ZL
authors.lastname: Liang
authors.forename: Qun-Ying
authors.initials: QY
authors.lastname: Mao
authors.forename: Yi-Ping
authors.initials: YP
authors.lastname: Wang
authors.forename: Feng-Cai
authors.initials: FC
authors.lastname: Zhu
authors.forename: Jing-Xin
authors.initials: JX
authors.lastname: Li
authors.forename: Xin
authors.initials: X
authors.lastname: Yao
authors.forename: Fan
authors.initials: F
authors.lastname: Gao
authors.forename: Xing
authors.initials: X
authors.lastname: Wu
authors.forename: Miao
authors.initials: M
authors.lastname: Xu
authors.forename: Jun-Zhi
authors.initials: JZ
authors.lastname: Wang
mesh_terms: D002681:China / Q000453:epidemiology; D002986:Clinical Trials as Topic; D055808:Drug Discovery / Q000639:trends; D029821:Enterovirus A, Human / Q000276:immunology*; D004769:Enterovirus Infections / Q000453:epidemiology* / Q000517:prevention & control*; D006801:Humans; D012846:Singapore / Q000453:epidemiology; D013624:Taiwan / Q000453:epidemiology; D015164:Vaccines, Inactivated / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology / Q000302:isolation & purification; D014765:Viral Vaccines / Q000008:administration & dosage / Q000009:adverse effects / Q000276:immunology* / Q000302:isolation & purification
chemical_list: D015164:Vaccines, Inactivated; D014765:Viral Vaccines
keywords: enterovirus 71; hand-foot-mouth diseases (HFMD); immunogenicity; inactivated whole-virus vaccine; protective effect; standard