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[Preprint]. 2021 Jan 19:2021.01.05.422952. Originally published 2021 Jan 5. [Version 3] doi: 10.1101/2021.01.05.422952

Immunogenicity of an AAV-based, room-temperature stable, single dose COVID-19 vaccine in mice and non-human primates

Nerea Zabaleta, Wenlong Dai, Urja Bhatt, Jessica A Chichester, Julio Sanmiguel, Reynette Estelien, Kristofer T Michalson, Cheikh Diop, Dawid Maciorowski, Wenbin Qi, Elissa Hudspeth, Allison Cucalon, Cecilia D Dyer, M Betina Pampena, James J Knox, Regina C LaRocque, Richelle C Charles, Dan Li, Maya Kim, Abigail Sheridan, Nadia Storm, Rebecca I Johnson, Jared Feldman, Blake M Hauser, Eric Zinn, Aisling Ryan, Dione T Kobayashi, Ruchi Chauhan, Marion McGlynn, Edward T Ryan, Aaron G Schmidt, Brian Price, Anna Honko, Anthony Griffiths, Sam Yaghmour, Robert Hodge, Michael R Betts, Mason W Freeman, James M Wilson, Luk H Vandenberghe
PMCID: PMC7805441  PMID: 33442684

Abstract

The SARS-CoV-2 pandemic has affected more than 70 million people worldwide and resulted in over 1.5 million deaths. A broad deployment of effective immunization campaigns to achieve population immunity at global scale will depend on the biological and logistical attributes of the vaccine. Here, two adeno-associated viral (AAV)-based vaccine candidates demonstrate potent immunogenicity in mouse and nonhuman primates following a single injection. Peak neutralizing antibody titers remain sustained at 5 months and are complemented by functional memory T-cells responses. The AAVrh32.33 capsid of the AAVCOVID vaccine is an engineered AAV to which no relevant pre-existing immunity exists in humans. Moreover, the vaccine is stable at room temperature for at least one month and is produced at high yields using established commercial manufacturing processes in the gene therapy industry. Thus, this methodology holds as a very promising single dose, thermostable vaccine platform well-suited to address emerging pathogens on a global scale.

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