Inactivated and Immunogenic SARS-CoV-2 for Safe Use in Immunoassays and as an Immunization Control for Non-Clinical Trials

Successful SARS-CoV-2 inactivation allows its safe use in Biosafety Level 2 facilities, and the of whole viral particle helps development analytical methods a more reliable immune response, contributing to improvement vitro vivo assays. In order obtain functional product, we evaluated several protocols observed that 0.03% beta-propiolactone for 24 h was best condition tested, as it promoted above 99.99% no cytopathic effect visualized after five serial passages. Moreover, RT-qPCR transmission electron microscopy revealed RNA quantification structure integrity were preserved. The antigenicity inactivated confirmed by ELISA using different Spike-neutralizing monoclonal antibodies. K18-hACE2 mice immunized with SARS-CoV-2, formulated AddaS03TM, presented high neutralizing antibody titers, significant weight loss, longer survival than controls from lethal challenge, despite detection oropharyngeal swab, lung, brain. This work emphasizes importance techniques confirm avoid potentially disastrous contamination. We believe an efficiently product can be used applications, including molecular diagnostic kits, antigen production well control non-clinical trials.