Hemagglutinin Quantitative ELISA-based Potency Assay for Trivalent Seasonal Influenza Vaccine Using Group-Specific Universal Monoclonal Antibodies

Wonil Chae,Yu Cheol Cheong,Sang Moo Kang,Paul Kim,Hanna Kim,Young-Seok Kim,Baik L Seong

doi:10.1038/s41598-019-56169-5

Wonil Chae, Yu Cheol Cheong + Show 5 more

Open Access

https://doi.org/10.1038/s41598-019-56169-5

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Journal: Scientific Reports	Publication Date: Dec 1, 2019
Citations: 7	License type: open-access

Affiliation: Yonsei University, Georgia State University

Abstract

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.

Highlights

The assurance of vaccine potency is important for the timely release and distribution of influenza vaccines
The HA quantitative enzyme-linked immunosorbent assay (ELISA) for trivalent influenza vaccine using uAbs was validated for the potency assay of the trivalent vaccine, comprised of H1N1, H3N2, and influenza B virus (IBV), with good correlation with the Single Radial Immunodiffusion (SRID)-based method
The consensus HA (cHA) stalk for group 1 influenza A virus (IAV) was designed and validated previously[15]

Summary

Introduction

The assurance of vaccine potency is important for the timely release and distribution of influenza vaccines. 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 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. The HA quantitative ELISA for trivalent influenza vaccine using uAbs was validated for the potency assay of the trivalent vaccine, comprised of H1N1 (group 1 IAV), H3N2 (group 2 IAV), and IBV, with good correlation with the SRID-based method. The impact of the present assay could be far-reaching; in addition to seasonal vaccines, the same assay platform could be further extended to potential pandemic vaccines of H5N1 virus of group 1 and H7N9 virus of group 210,11, and for HA stalk-based universal influenza vaccines[12,13,14]

Methods

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Conclusion