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Sci Rep. 2019 Dec 23;9(1):19675. doi: 10.1038/s41598-019-56169-5. [h=1]Hemagglutinin Quantitative ELISA-based Potency Assay for Trivalent Seasonal Influenza Vaccine Using Group-Specific Universal Monoclonal Antibodies.[/h]
Chae W[SUP]1,[/SUP][SUP]2[/SUP], Kim P[SUP]2,[/SUP][SUP]3[/SUP], Kim H[SUP]1,[/SUP][SUP]2[/SUP], Cheong YC[SUP]1,[/SUP][SUP]2[/SUP], Kim YS[SUP]1,[/SUP][SUP]2[/SUP], Kang SM[SUP]4[/SUP], Seong BL[SUP]5,[/SUP][SUP]6[/SUP].
[h=3]Author information[/h] 1 Department of Biotechnology, College of Life Science and Biotechnology, Yonsei University, Seoul, Republic of Korea. 2 Vaccine Translational Research Center, Yonsei University, Seoul, Republic of Korea. 3 Department of Integrated OMICS for Biomedical Science, College of World Class University, Yonsei University, Seoul, Republic of Korea. 4 Center for Inflammation, Immunity & Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, GA, USA. 5 Department of Biotechnology, College of Life Science and Biotechnology, Yonsei University, Seoul, Republic of Korea. blseong@yonsei.ac.kr. 6 Vaccine Translational Research Center, Yonsei University, Seoul, Republic of Korea. blseong@yonsei.ac.kr.
[h=3]Abstract[/h] The assurance of vaccine potency is important for the timely release and distribution of influenza vaccines. As an alternative to Single Radial Immunodiffusion (SRID), we report a new quantitative enzyme-linked immunosorbent assay (ELISA) for seasonal trivalent influenza vaccine (TIV). The consensus hemagglutinin (cHA) stalks for group 1 influenza A virus (IAV), group 2 IAV, and influenza B virus (IBV) were designed and produced in bacterial recombinant host in a soluble form, and monoclonal antibodies (mAbs) were generated. The group-specific 'universal' mAbs (uAbs) bound to various subtypes of HAs in the same group from recombinant hosts, embryonated eggs, and commercial vaccine lots. The calibration curves were generated to assess the sensitivity, specificity, accuracy, and linear dynamic range. The quantitative ELISA was validated for the potency assay of individual components of TIV- H1, H3, and IBV- with good correlation with the SRID method. This new assay could be extended to pandemic or pre-pandemic mock-up vaccines of H5 of group 1 and H7 virus of group 2, and novel HA stalk-based universal vaccines.
PMID: 31873147 DOI: 10.1038/s41598-019-56169-5
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Chae W[SUP]1,[/SUP][SUP]2[/SUP], Kim P[SUP]2,[/SUP][SUP]3[/SUP], Kim H[SUP]1,[/SUP][SUP]2[/SUP], Cheong YC[SUP]1,[/SUP][SUP]2[/SUP], Kim YS[SUP]1,[/SUP][SUP]2[/SUP], Kang SM[SUP]4[/SUP], Seong BL[SUP]5,[/SUP][SUP]6[/SUP].
[h=3]Author information[/h] 1 Department of Biotechnology, College of Life Science and Biotechnology, Yonsei University, Seoul, Republic of Korea. 2 Vaccine Translational Research Center, Yonsei University, Seoul, Republic of Korea. 3 Department of Integrated OMICS for Biomedical Science, College of World Class University, Yonsei University, Seoul, Republic of Korea. 4 Center for Inflammation, Immunity & Infection, Institute for Biomedical Sciences, Georgia State University, Atlanta, GA, USA. 5 Department of Biotechnology, College of Life Science and Biotechnology, Yonsei University, Seoul, Republic of Korea. blseong@yonsei.ac.kr. 6 Vaccine Translational Research Center, Yonsei University, Seoul, Republic of Korea. blseong@yonsei.ac.kr.
[h=3]Abstract[/h] The assurance of vaccine potency is important for the timely release and distribution of influenza vaccines. As an alternative to Single Radial Immunodiffusion (SRID), we report a new quantitative enzyme-linked immunosorbent assay (ELISA) for seasonal trivalent influenza vaccine (TIV). The consensus hemagglutinin (cHA) stalks for group 1 influenza A virus (IAV), group 2 IAV, and influenza B virus (IBV) were designed and produced in bacterial recombinant host in a soluble form, and monoclonal antibodies (mAbs) were generated. The group-specific 'universal' mAbs (uAbs) bound to various subtypes of HAs in the same group from recombinant hosts, embryonated eggs, and commercial vaccine lots. The calibration curves were generated to assess the sensitivity, specificity, accuracy, and linear dynamic range. The quantitative ELISA was validated for the potency assay of individual components of TIV- H1, H3, and IBV- with good correlation with the SRID method. This new assay could be extended to pandemic or pre-pandemic mock-up vaccines of H5 of group 1 and H7 virus of group 2, and novel HA stalk-based universal vaccines.
PMID: 31873147 DOI: 10.1038/s41598-019-56169-5
Free full text