4.5 Article

Progress on the research and development of inactivated EV71 whole-virus vaccines

Journal

HUMAN VACCINES & IMMUNOTHERAPEUTICS
Volume 9, Issue 8, Pages 1701-1705

Publisher

LANDES BIOSCIENCE
DOI: 10.4161/hv.24949

Keywords

enterovirus 71; hand-foot-mouth diseases (HFMD); inactivated whole-virus vaccine; immunogenicity; protective effect; standard

Funding

  1. National 12th Five Major Special Projects Funding Program from the Ministry of Science and Technology of the People's Republic of China [2012ZX10004701]
  2. National High Technology Research and Development Program (863 program) from the Ministry of Science and Technology of the People's Republic of China [2012AA02A402]

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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.

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