Gamma-irradiated SARS-CoV-2 vaccine candidate, OZG-38.61.3, confers protection from SARS-CoV-2 challenge in human ACEII-transgenic mice

Abstract The SARS-CoV-2 virus caused the most severe pandemic around world, and vaccine development for urgent use became a crucial issue. Inactivated formulated vaccines such as Hepatitis A smallpox proved to be reliable approaches immunization prolonged periods. In this study, gamma-irradiated inactivated does not require an extra purification process, unlike chemically vaccines. Hence, novelty of our candidate (OZG-38.61.3) is that it non-adjuvant added, gamma-irradiated, intradermally applied inactive viral vaccine. Efficiency safety dose (either 10 13 or 14 RNA copy per dose) OZG-38.61.3 was initially determined in BALB/c mice. This followed by testing immunogenicity protective efficacy Human ACE2-encoding transgenic mice were immunized then infected with challenge test. study shows vaccinated have lowered numbers both oropharyngeal specimens histological analysis lung tissues along humoral cellular immune responses, including neutralizing antibodies similar those shown without substantial toxicity. Subsequently, plans are being made commencement Phase 1 clinical trial COVID-19 pandemic.