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A linear DNA vaccine candidate encoding the SARS-CoV-2 Receptor Binding Domain elicits protective immunity in domestic cats

View ORCID ProfileAntonella Conforti, Elisa Sanchez, View ORCID ProfileErika Salvatori, View ORCID ProfileLucia Lione, View ORCID ProfileMirco Compagnone, Eleonora Pinto, View ORCID ProfileFabio Palombo, Yuhua Sun, Brian Viscount, James Hayward, Clay Shorrock, View ORCID ProfileDiego G. Diel, View ORCID ProfileJoseph A. Impellizeri, View ORCID ProfileLuigi Aurisicchio
doi: https://doi.org/10.1101/2022.07.20.500860
Antonella Conforti
1Takis Biotech, Via Castel Romano 100, 00128 Rome, Italy
2Evvivax Biotech, Via Castel Romano 100, 00128 Rome, Italy
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  • ORCID record for Antonella Conforti
  • For correspondence: conforti@evvivax.com aurisicchio@evvivax.com
Elisa Sanchez
3Veterinary Oncology Services (VOS, PLLC New York, USA)
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Erika Salvatori
1Takis Biotech, Via Castel Romano 100, 00128 Rome, Italy
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  • ORCID record for Erika Salvatori
Lucia Lione
1Takis Biotech, Via Castel Romano 100, 00128 Rome, Italy
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  • ORCID record for Lucia Lione
Mirco Compagnone
4Neomatrix Biotech, Via Castel Romano 100, 00128 Rome, Italy
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  • ORCID record for Mirco Compagnone
Eleonora Pinto
1Takis Biotech, Via Castel Romano 100, 00128 Rome, Italy
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Fabio Palombo
1Takis Biotech, Via Castel Romano 100, 00128 Rome, Italy
4Neomatrix Biotech, Via Castel Romano 100, 00128 Rome, Italy
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  • ORCID record for Fabio Palombo
Yuhua Sun
5Applied DNA Sciences, Inc. 50 Health Sciences Drive, Stony Brook, NY 11790
6LineaRx, Inc. 50 Health Sciences Drive, Stony Brook, NY 11790
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Brian Viscount
5Applied DNA Sciences, Inc. 50 Health Sciences Drive, Stony Brook, NY 11790
6LineaRx, Inc. 50 Health Sciences Drive, Stony Brook, NY 11790
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James Hayward
5Applied DNA Sciences, Inc. 50 Health Sciences Drive, Stony Brook, NY 11790
6LineaRx, Inc. 50 Health Sciences Drive, Stony Brook, NY 11790
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Clay Shorrock
5Applied DNA Sciences, Inc. 50 Health Sciences Drive, Stony Brook, NY 11790
6LineaRx, Inc. 50 Health Sciences Drive, Stony Brook, NY 11790
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Diego G. Diel
7Department of Population Medicine and Diagnostic Sciences, Animal Health Diagnostic Center, College of Veterinary Medicine, Cornell University, Ithaca, NY 14850
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  • ORCID record for Diego G. Diel
Joseph A. Impellizeri
3Veterinary Oncology Services (VOS, PLLC New York, USA)
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  • ORCID record for Joseph A. Impellizeri
Luigi Aurisicchio
1Takis Biotech, Via Castel Romano 100, 00128 Rome, Italy
2Evvivax Biotech, Via Castel Romano 100, 00128 Rome, Italy
4Neomatrix Biotech, Via Castel Romano 100, 00128 Rome, Italy
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  • ORCID record for Luigi Aurisicchio
  • For correspondence: conforti@evvivax.com aurisicchio@evvivax.com
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ABSTRACT

Since its first detection in China in late 2019, SARS-CoV-2, the etiologic agent of COVID-19 pandemic, has infected a wide range of animal species, especially mammals, all over the world. Indeed, as reported by the American Veterinary Medical Association, besides human-to-human transmission, human-to-animal transmission has been observed in some wild animals and pets, especially in cats. With animal models as an invaluable tool in the study of infectious diseases combined with the fact that the intermediate animal source of SARS-CoV-2 is still unknown, researchers have demonstrated that cats are permissive to COVID-19 and are susceptible to airborne infections. Given the high transmissibility potential of SARS-CoV-2 to different host species and the close contact between humans and animals, it is crucial to find mechanisms to prevent the transmission chain and reduce the risk of spillover to susceptible species. Here, we show results from a randomized Phase I/II clinical study conducted in domestic cats to assess safety and immunogenicity of a linear DNA (“linDNA”) vaccine encoding the RBD domain of SARS-CoV-2. No significant adverse events occurred and both RBD-specific binding/neutralizing antibodies and T cells were detected. These findings demonstrate the safety and immunogenicity of a genetic vaccine against COVID-19 administered to cats and strongly support the development of vaccines for preventing viral spread in susceptible species, especially those in close contact with humans.

Competing Interest Statement

Evvivax, Takis and NeoMatrix are currently developing proprietary nucleic-acid vaccines based on DNA-EGT. Applied DNA and LineaRx is commercializing LinearDNA, its proprietary, large-scale PCR-based manufacturing platform that allows for the large-scale production of specific DNA sequences for biotherapeutic applications. The Company common stock is listed on NASDAQ under ticker symbol APDN, and its publicly traded warrants are listed on OTC under ticker symbol APPDW.

Copyright 
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 July 22, 2022.
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A linear DNA vaccine candidate encoding the SARS-CoV-2 Receptor Binding Domain elicits protective immunity in domestic cats
Antonella Conforti, Elisa Sanchez, Erika Salvatori, Lucia Lione, Mirco Compagnone, Eleonora Pinto, Fabio Palombo, Yuhua Sun, Brian Viscount, James Hayward, Clay Shorrock, Diego G. Diel, Joseph A. Impellizeri, Luigi Aurisicchio
bioRxiv 2022.07.20.500860; doi: https://doi.org/10.1101/2022.07.20.500860
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A linear DNA vaccine candidate encoding the SARS-CoV-2 Receptor Binding Domain elicits protective immunity in domestic cats
Antonella Conforti, Elisa Sanchez, Erika Salvatori, Lucia Lione, Mirco Compagnone, Eleonora Pinto, Fabio Palombo, Yuhua Sun, Brian Viscount, James Hayward, Clay Shorrock, Diego G. Diel, Joseph A. Impellizeri, Luigi Aurisicchio
bioRxiv 2022.07.20.500860; doi: https://doi.org/10.1101/2022.07.20.500860

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