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Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice

Chih-Yun Lai, View ORCID ProfileAlbert To, Teri Ann S. Wong, Michael M. Lieberman, David E. Clements, James T. Senda, Aquena H. Ball, Laurent Pessaint, Hanne Andersen, Oreola Donini, Axel T. Lehrer
doi: https://doi.org/10.1101/2021.03.02.433614
Chih-Yun Lai
aDepartment of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, USA
bPacific Center for Emerging Infectious Disease Research, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, USA
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Albert To
aDepartment of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, USA
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  • ORCID record for Albert To
Teri Ann S. Wong
aDepartment of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, USA
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Michael M. Lieberman
aDepartment of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, USA
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David E. Clements
cHawaii Biotech, Inc., Honolulu, HI, USA
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James T. Senda
cHawaii Biotech, Inc., Honolulu, HI, USA
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Aquena H. Ball
aDepartment of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, USA
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Laurent Pessaint
dBioqual Inc., Rockville, MD, USA
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Hanne Andersen
dBioqual Inc., Rockville, MD, USA
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Oreola Donini
eSoligenix, Inc, Princetown, NJ, USA
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Axel T. Lehrer
aDepartment of Tropical Medicine, Medical Microbiology, and Pharmacology, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, USA
bPacific Center for Emerging Infectious Disease Research, John A. Burns School of Medicine, University of Hawaii at Manoa, Honolulu, HI, USA
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  • For correspondence: lehrer@hawaii.edu
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ABSTRACT

The speed at which several COVID-19 vaccines went from conception to receiving FDA and EMA approval for emergency use is an achievement unrivaled in the history of vaccine development. Mass vaccination efforts using the highly effective vaccines are currently underway to generate sufficient herd immunity and reduce transmission of the SARS-CoV-2 virus. Despite the most advanced vaccine technology, global recipient coverage, especially in resource-poor areas remains a challenge as genetic drift in naïve population pockets threatens overall vaccine efficacy. In this study, we described the production of insect-cell expressed SARS-CoV-2 spike protein ectodomain and examined its immunogenicity in mice. We demonstrated that, when formulated with CoVaccine HT™adjuvant, an oil-in-water nanoemulsion compatible with lyophilization, our vaccine candidates elicit a broad-spectrum IgG response, high neutralizing antibody titers, and a robust, antigen-specific IFN-γ secreting response from immune splenocytes in outbred mice. Our findings lay the foundation for the development of a dry-thermostabilized vaccine that is deployable without refrigeration.

Competing Interest Statement

Axel T. Lehrer and Oreola Donini are named inventors on a patent application covering a recombinant subunit vaccine for SARS-CoV-2. David E. Clements and James T. Senda, are current employees of Hawaii Biotech Inc. Laurent Pessaint and Hanne Andersen are current employees of BIOQUAL, Inc. Oreola Donini is a current employee of Soligenix Inc. We declare that the research was conducted in the absence of any commercial or financial relationships that could be construed as a potential conflict of interest.

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The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. All rights reserved. No reuse allowed without permission.
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Posted March 03, 2021.
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Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice
Chih-Yun Lai, Albert To, Teri Ann S. Wong, Michael M. Lieberman, David E. Clements, James T. Senda, Aquena H. Ball, Laurent Pessaint, Hanne Andersen, Oreola Donini, Axel T. Lehrer
bioRxiv 2021.03.02.433614; doi: https://doi.org/10.1101/2021.03.02.433614
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Recombinant protein subunit SARS-CoV-2 vaccines formulated with CoVaccine HT adjuvant induce broad, Th1 biased, humoral and cellular immune responses in mice
Chih-Yun Lai, Albert To, Teri Ann S. Wong, Michael M. Lieberman, David E. Clements, James T. Senda, Aquena H. Ball, Laurent Pessaint, Hanne Andersen, Oreola Donini, Axel T. Lehrer
bioRxiv 2021.03.02.433614; doi: https://doi.org/10.1101/2021.03.02.433614

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