國家衛生研究院 NHRI:Item 3990099045/15470
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    题名: The stability and immunogenicity of formalin-inactivated Enterovirus A71 whole virion vaccine after ten years of low temperature storage
    作者: Shen, YS;Chow, YH;Fang, CY;Wu, SR;Chen, CH;Huang, MH;Liao, CL;Chiang, JR;Liu, CC
    贡献者: National Institute of Infectious Diseases and Vaccinology
    摘要: Background: Vaccine stability is an important issue for vaccine development, which affects whether the vaccine product is effective within a certain period of time in each progress. Hand, foot, and mouth diseases (HFMD) is an epidemic disease in young children usually caused by Enterovirus A group viruses, and the Enterovirus A71 (EV-A71) had caused several pandemics and public health issues around the world. After two decades of research and development, formalin-inactivated EV-A71 (FI-EV-A71) vaccines are the first to complete the phase III clinical trials for protection against EV-A71 infection. Currently, the shelf life of FI-EV-A71 vaccine product is set to be within 18 months, but the stability and the effectiveness of the FI-EV-A71 whole virion when stored long-term at low temperature remains undetermined. Methods: Assessing the long-term storage properties of viral particles facilitates flexibility in manufacturing of vaccine products. In this study, the stability profiles of FI-EV-A71 vaccine lots and bulks after long-term of low temperature storage were analyzed by protein tests, particle measurement and animal immunization study. Results: After over ten years of storage, the reduction of protein concentration in the FI-EV-A71 bulk samples is less than 30 % and the antigenic content remained in a suspended, particulate state. Both the packed FI-EV-A71 final vaccine products and the FI-EV-A71 antigens adjuvant premix bulk could elicit strong neutralizing responses in mice. Conclusion: After ten years of low temperature storage, the FI-EV-A71 vaccine still presents decent stability and good immunogenicity.
    日期: 2023-12
    關聯: Journal of Microbiology, Immunology and Infection. 2023 Dec;56(6):1121-1128.
    Link to: http://dx.doi.org/10.1016/j.jmii.2023.10.006
    JIF/Ranking 2023: http://gateway.webofknowledge.com/gateway/Gateway.cgi?GWVersion=2&SrcAuth=NHRI&SrcApp=NHRI_IR&KeyISSN=1684-1182&DestApp=IC2JCR
    Cited Times(WOS): https://www.webofscience.com/wos/woscc/full-record/WOS:001141811000001
    Cited Times(Scopus): https://www.scopus.com/inward/record.url?partnerID=HzOxMe3b&scp=85175469491
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