TY - JOUR T1 - Immunogenicity and pre-clinical efficacy of an OMV-based SARS-CoV-2 vaccine JF - bioRxiv DO - 10.1101/2021.07.12.452027 SP - 2021.07.12.452027 AU - Alberto Grandi AU - Michele Tomasi AU - Cinzia Bertelli AU - Teresa Vanzo AU - Assunta Gagliardi AU - Elena Caproni AU - Silvia Tamburini AU - Laura Fantappiè AU - Gabriele Di Lascio AU - Zeno Bisoffi AU - Chiara Piubelli AU - Maria Teresa Valenti AU - Luca Dalle Carbonare AU - Donato Zipeto AU - Micol Ravà AU - Valeria Fumagalli AU - Pietro Di Lucia AU - Davide Marotta AU - Eleonora Sala AU - Matteo Iannacone AU - Peter Cherepanov AU - Martino Bolognesi AU - Massimo Pizzato AU - Guido Grandi Y1 - 2021/01/01 UR - http://biorxiv.org/content/early/2021/07/13/2021.07.12.452027.abstract N2 - The vaccination campaign against SARS-CoV-2 relies on the world-wide availability of effective vaccines, with a potential need of 20 billion vaccine doses to fully vaccinate the world population. To reach this goal, the manufacturing and logistic processes should be affordable to all countries, irrespectively of economical and climatic conditions.Outer membrane vesicles (OMVs) are bacterial-derived vesicles that can be engineered to incorporate heterologous antigens. Given the inherent adjuvanticity, such modified OMVs can be used as vaccine to induce potent immune responses against the associated protein. Here we show that OMVs engineered to incorporate peptides derived from the receptor binding motif (RBM) of the spike protein from SARS-CoV-2 elicit an effective immune response in immunized mice, resulting in the production of neutralizing antibodies. The immunity induced by the vaccine is sufficient to protect K18-hACE2 transgenic mice from intranasal challenge with SARS-CoV-2, preventing both virus replication in the lungs and the pathology associated with virus infection. Furthermore, we show that OMVs can be effectively decorated with RBM peptides derived from a different genetic variant of SARS-CoV-2, inducing a similarly potent neutralization activity in vaccinated mice. Altogether, given the convenience associated with ease of engineering, production and distribution, our results demonstrate that OMV-based SARS-CoV-2 vaccines can be a crucial addition to the vaccines currently available.Competing Interest StatementG.G., L.F., A.G., M.P., e M.P. are coinventors of patents on OMVs; A.G. and G.G. are involved in a biotech company interested in exploiting the OMV platform. M.I. participates in advisory boards/consultancies for or receives funding from Gilead Sciences, Roche, Third Rock Ventures, Amgen, Allovir, Asher Bio. ER -