biostudies-literatureSir Karakus GAcibadem Healthcare GroupTUBITAK-BIDEB 2244-University-Industry PhD programTÜBİTAK 2247-C Trainee Researcher Scholarship Program5804https://www.ebi.ac.uk/biostudies/studies/S-EPMC7970959biostudies-literatureUnknown11(1)COVID-19 outbreak caused by SARS-CoV-2 created an unprecedented health crisis since there is no vaccine for this novel virus. Therefore, SARS-CoV-2 vaccines have become crucial for reducing morbidity and mortality. In this study, in vitro and in vivo safety and efficacy analyzes of lyophilized vaccine candidates inactivated by gamma-irradiation were performed. The candidate vaccines in this study were OZG-3861 version 1 (V1), an inactivated SARS-CoV-2 virus vaccine, and SK-01 version 1 (V1), a GM-CSF adjuvant added vaccine. The candidate vaccines were applied intradermally to BALB/c mice to assess toxicity and immunogenicity. Preliminary results in vaccinated mice are reported in this study. Especially, the vaccine models containing GM-CSF caused significant antibody production with neutraScientific reportsPreclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates.PMC7970959118C082Telci DAkyoney SOzbek UElek MRatip SHemsinlioglu CTastan CTumentemur GSahin FTuran RDYalcin KAbanuz SOzer SArbak SSahin IErtop GSir Karakus GAcikel Elmas MCakirsoy DDilek Kancagi DOvali EDemir SKocagoz ASElibol OYurtsever BHatirnaz Ng OSeyis UfalsePreclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates.COVID-19 outbreak caused by SARS-CoV-2 created an unprecedented health crisis since there is no vaccine for this novel virus. Therefore, SARS-CoV-2 vaccines have become crucial for reducing morbidity and mortality. In this study, in vitro and in vivo safety and efficacy analyzes of lyophilized vaccine candidates inactivated by gamma-irradiation were performed. The candidate vaccines in this study were OZG-3861 version 1 (V1), an inactivated SARS-CoV-2 virus vaccine, and SK-01 version 1 (V1), a GM-CSF adjuvant added vaccine. The candidate vaccines were applied intradermally to BALB/c mice to assess toxicity and immunogenicity. Preliminary results in vaccinated mice are reported in this study. Especially, the vaccine models containing GM-CSF caused significant antibody production with neutra2021-01-01T00:00:00Z2021 Mar2026-07-16T10:10:18.61Z2025-04-21T17:10:41.255ZS-EPMC79709593370753210.1038/s41598-021-83930-6