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Replicating RNA platform enables rapid response to the SARS-CoV-2 Omicron variant and elicits enhanced protection in naïve hamsters compared to ancestral vaccine

David W. Hawman, Kimberly Meade-White, Chad Clancy, Jacob Archer, Troy Hinkley, Shanna S. Leventhal, Deepashri Rao, Allie Stamper, Matthew Lewis, Rebecca Rosenke, Kyle Krieger, Samantha Randall, Amit P. Khandhar, Linhue Hao, Tien-Ying Hsiang, View ORCID ProfileAlexander L. Greninger, Michael Gale Jr, Peter Berglund, Deborah Heydenburg Fuller, Kyle Rosenke, Heinz Feldmann, Jesse H. Erasmus
doi: https://doi.org/10.1101/2022.01.31.478520
David W. Hawman
1Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Kimberly Meade-White
1Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Chad Clancy
2Rocky Mountain Veterinary Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Jacob Archer
3HDT Bio, Seattle, WA 98102, USA
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Troy Hinkley
4Department of Microbiology, University of Washington School of Medicine, Seattle, WA 98109, USA
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Shanna S. Leventhal
1Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Deepashri Rao
1Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Allie Stamper
1Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Matthew Lewis
1Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Rebecca Rosenke
2Rocky Mountain Veterinary Branch, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Kyle Krieger
3HDT Bio, Seattle, WA 98102, USA
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Samantha Randall
4Department of Microbiology, University of Washington School of Medicine, Seattle, WA 98109, USA
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Amit P. Khandhar
3HDT Bio, Seattle, WA 98102, USA
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Linhue Hao
5Center for Innate Immunity and Immune Disease, Department of Immunology, University of Washington School of Medicine, Seattle, WA 98109, USA
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Tien-Ying Hsiang
5Center for Innate Immunity and Immune Disease, Department of Immunology, University of Washington School of Medicine, Seattle, WA 98109, USA
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Alexander L. Greninger
6Department of Laboratory Medicine and Pathology, University of Washington School of Medicine, Seattle, WA 98109, USA
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  • ORCID record for Alexander L. Greninger
Michael Gale Jr
5Center for Innate Immunity and Immune Disease, Department of Immunology, University of Washington School of Medicine, Seattle, WA 98109, USA
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Peter Berglund
3HDT Bio, Seattle, WA 98102, USA
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Deborah Heydenburg Fuller
4Department of Microbiology, University of Washington School of Medicine, Seattle, WA 98109, USA
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Kyle Rosenke
1Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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Heinz Feldmann
1Laboratory of Virology, Division of Intramural Research, National Institute of Allergy and Infectious Diseases, National Institutes of Health, Rocky Mountain Laboratories, Hamilton, MT 59840, USA
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  • For correspondence: jesse.erasmus@hdt.bio
Jesse H. Erasmus
3HDT Bio, Seattle, WA 98102, USA
4Department of Microbiology, University of Washington School of Medicine, Seattle, WA 98109, USA
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  • For correspondence: jesse.erasmus@hdt.bio
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Abstract

In late 2021, the SARS-CoV-2 Omicron (B.1.1.529) variant of concern (VoC) was reported with many mutations in the viral spike protein that were predicted to enhance transmissibility and allow viral escape of neutralizing antibodies. Within weeks of the first report of B.1.1.529, this VoC has rapidly spread throughout the world, replacing previously circulating strains of SARS-CoV-2 and leading to a resurgence in COVID-19 cases even in populations with high levels of vaccine- and infection-induced immunity. Initial studies have shown that B.1.1.529 is less sensitive to protective antibody conferred by previous infections and vaccines developed against earlier lineages of SARS-CoV-2. The ability of B.1.1.529 to spread even among vaccinated populations has led to a global public health demand for updated vaccines that can confer protection against B.1.1.529. We report here the rapid development of a replicating RNA vaccine expressing the B.1.1.529 spike and show that this B.1.1.529-targeted vaccine is immunogenic in mice and hamsters. Interestingly, we found that mice previously immunized with A.1-specific vaccines failed to elevate neutralizing antibody titers against B.1.1.529 following B.1.1.529-targeted boosting, suggesting pre-existing immunity may impact the efficacy of B.1.1.529-targeted boosters. Furthermore, we found that our B.1.1.529-targeted vaccine provides superior protection compared to the ancestral A.1-targeted vaccine in hamsters challenged with the B.1.1.529 VoC after a single dose of each vaccine.

One Sentence Summary Rapidly developed RNA vaccine protects against SARS-CoV-2 Omicron variant

Competing Interest Statement

JHE, APK, JA, PB, MGJ, and DHF have equity interest in HDT Bio Corp. JHE and APK are inventors on U.S. patent application no. 62/993,307 pertaining to the LION formulation. JHE, PB, and DHF have current or previous consulting agreements with various life sciences companies.

Copyright 
The copyright holder for this preprint is the author/funder, who has granted bioRxiv a license to display the preprint in perpetuity. This article is a US Government work. It is not subject to copyright under 17 USC 105 and is also made available for use under a CC0 license.
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Posted February 03, 2022.
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Replicating RNA platform enables rapid response to the SARS-CoV-2 Omicron variant and elicits enhanced protection in naïve hamsters compared to ancestral vaccine
David W. Hawman, Kimberly Meade-White, Chad Clancy, Jacob Archer, Troy Hinkley, Shanna S. Leventhal, Deepashri Rao, Allie Stamper, Matthew Lewis, Rebecca Rosenke, Kyle Krieger, Samantha Randall, Amit P. Khandhar, Linhue Hao, Tien-Ying Hsiang, Alexander L. Greninger, Michael Gale Jr, Peter Berglund, Deborah Heydenburg Fuller, Kyle Rosenke, Heinz Feldmann, Jesse H. Erasmus
bioRxiv 2022.01.31.478520; doi: https://doi.org/10.1101/2022.01.31.478520
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Replicating RNA platform enables rapid response to the SARS-CoV-2 Omicron variant and elicits enhanced protection in naïve hamsters compared to ancestral vaccine
David W. Hawman, Kimberly Meade-White, Chad Clancy, Jacob Archer, Troy Hinkley, Shanna S. Leventhal, Deepashri Rao, Allie Stamper, Matthew Lewis, Rebecca Rosenke, Kyle Krieger, Samantha Randall, Amit P. Khandhar, Linhue Hao, Tien-Ying Hsiang, Alexander L. Greninger, Michael Gale Jr, Peter Berglund, Deborah Heydenburg Fuller, Kyle Rosenke, Heinz Feldmann, Jesse H. Erasmus
bioRxiv 2022.01.31.478520; doi: https://doi.org/10.1101/2022.01.31.478520

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