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An AAV-based, room-temperature-stable, single-dose COVID-19 vaccine provides durable immunogenicity and protection in non-human primates

Zabaleta, N;Dai, W;Bhatt, U;Hérate, C;Maisonnasse, P;Chichester, JA;Sanmiguel, J;Estelien, R;Michalson, KT;Diop, C;Maciorowski, D;Dereuddre-Bosquet, N;Cavarelli, M;Gallouët, AS;Naninck, T;Kahlaoui, N;Lemaitre, J;Qi, W;Hudspeth, E;Cucalon, A;Dyer, CD;Pampena, MB;Knox, JJ;LaRocque, RC;Charles, RC;Li, D;Kim, M;Sheridan, A;Storm, N;Johnson, RI;Feldman, J;Hauser, BM;Contreras, V;Marlin, R;Tsong Fang, RH;Chapon, C;van der Werf, S;Zinn, E;Ryan, A;Kobayashi, DT;Chauhan, R;McGlynn, M;Ryan, ET;Schmidt, AG;Price, B;Honko, A;Griffiths, A;Yaghmour, S;Hodge, R;Betts, MR;Freeman, MW;Wilson, JM;Le Grand, R;Vandenberghe, LH;

The SARS-CoV-2 pandemic has affected more than 185 million people worldwide resulting in over 4 million deaths. To contain the pandemic, there is a continued need for safe vaccines that provide durable protection at low and scalable doses and can be deployed easily. Here, AAVCOVID-1, an adeno-associated viral (AAV), spike-gene-based vaccine candidate demonstrates potent immunogenicity in mouse and non-human primates following a single injection and confers complete protection from SARS-CoV-2 challenge in macaques. Peak neutralizing antibody titers are sustained at 1 year and complemented by functional memory T cell responses. The AAVCOVID vector has no relevant pre-existing immunity in humans and does not elicit cross-reactivity to common AAVs used in gene therapy. Vector genome persistence and expression wanes following injection. The single low-dose requirement, high-yield manufacturability, and 1-month stability for storage at room temperature may make this technology well suited to support effective immunization campaigns for emerging pathogens on a global scale.