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Vaccine. 2019 Aug 2. pii: S0264-410X(19)30346-9. doi: 10.1016/j.vaccine.2019.03.024. [Epub ahead of print]
The stability and immunogenicity of inactivated MDCK cell-derived influenza H7N9 viruses.
Tzeng TT1, Lai CC2, Weng TC1, Cyue MH1, Tsai SY1, Tseng YF1, Sung WC1, Lee MS1, Hu AY3.
Author information
1 National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes (NHRI), Taiwan. 2 National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes (NHRI), Taiwan; College of Life Science, National Tsing Hua University, Taiwan. 3 National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes (NHRI), Taiwan. Electronic address: alanhu@nhri.org.tw.
Abstract
In recent years, cell-based influenza vaccines have gained a great interest over the egg-based vaccines. Several inactivated H7N9 vaccines have been evaluated in clinical trials, including whole-virion vaccines, split vaccines and subunit vaccines. Recently, we developed a new suspension MDCK (sMDCK) cell line for influenza viruses production. However, the properties of purified antigen from sMDCK cells remain unclear. In this study, the stability of influenza H7N9 vaccine bulk derived from sMDCK cells was investigated, and the data were compared with the vaccine antigen derived from our characterized adhesion MDCK (aMDCK) cells in serum-free medium. The influenza H7N9 bulks derived from sMDCK and aMDCK cells were stored at 2-8 ?C for different periods of time, and a number of parameters selected to monitor the H7N9 vaccine antigen stability were evaluated at each interval (1, 3 and 12 months). The monitored parameters included virus morphology, hemagglutinin (HA) activity, HA concentration, antigenicity, and immunogenicity. The sMDCK-derived H7N9 bulk showed similar morphology to that of the aMDCK-derived H7N9 bulk, and there were no obvious changes after the extended storage periods. Furthermore, the HA titer, HA concentration, and antigenicity of sMDCK-derived H7N9 bulk were stable after 28 months of storage. Finally, the results of hemagglutination inhibition and neutralization tests showed that sMDCK- and aMDCK-derived H7N9 vaccines had comparable immunogenicity. These results indicated that sMDCK-derived H7N9 bulk has good stability compared to that of aMDCK-derived H7N9 bulk. Thus, the newly developed suspension MDCK cell line shows a great alternative for manufacturing cell-based influenza vaccines.
Copyright ? 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
H7N9; Inactivated influenza vaccine; Stability; Suspension MDCK
PMID: 31383484 DOI: 10.1016/j.vaccine.2019.03.024
The stability and immunogenicity of inactivated MDCK cell-derived influenza H7N9 viruses.
Tzeng TT1, Lai CC2, Weng TC1, Cyue MH1, Tsai SY1, Tseng YF1, Sung WC1, Lee MS1, Hu AY3.
Author information
1 National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes (NHRI), Taiwan. 2 National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes (NHRI), Taiwan; College of Life Science, National Tsing Hua University, Taiwan. 3 National Institute of Infectious Diseases and Vaccinology, National Health Research Institutes (NHRI), Taiwan. Electronic address: alanhu@nhri.org.tw.
Abstract
In recent years, cell-based influenza vaccines have gained a great interest over the egg-based vaccines. Several inactivated H7N9 vaccines have been evaluated in clinical trials, including whole-virion vaccines, split vaccines and subunit vaccines. Recently, we developed a new suspension MDCK (sMDCK) cell line for influenza viruses production. However, the properties of purified antigen from sMDCK cells remain unclear. In this study, the stability of influenza H7N9 vaccine bulk derived from sMDCK cells was investigated, and the data were compared with the vaccine antigen derived from our characterized adhesion MDCK (aMDCK) cells in serum-free medium. The influenza H7N9 bulks derived from sMDCK and aMDCK cells were stored at 2-8 ?C for different periods of time, and a number of parameters selected to monitor the H7N9 vaccine antigen stability were evaluated at each interval (1, 3 and 12 months). The monitored parameters included virus morphology, hemagglutinin (HA) activity, HA concentration, antigenicity, and immunogenicity. The sMDCK-derived H7N9 bulk showed similar morphology to that of the aMDCK-derived H7N9 bulk, and there were no obvious changes after the extended storage periods. Furthermore, the HA titer, HA concentration, and antigenicity of sMDCK-derived H7N9 bulk were stable after 28 months of storage. Finally, the results of hemagglutination inhibition and neutralization tests showed that sMDCK- and aMDCK-derived H7N9 vaccines had comparable immunogenicity. These results indicated that sMDCK-derived H7N9 bulk has good stability compared to that of aMDCK-derived H7N9 bulk. Thus, the newly developed suspension MDCK cell line shows a great alternative for manufacturing cell-based influenza vaccines.
Copyright ? 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.
KEYWORDS:
H7N9; Inactivated influenza vaccine; Stability; Suspension MDCK
PMID: 31383484 DOI: 10.1016/j.vaccine.2019.03.024