Preliminary report of preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates, SK-01 version 1 and OZG-3861 version 1

SIR KARAKUS, G.; Tastan, C.; Dilek Kancagi, D.; Yurtsever, B.; Tumentemur, G.; Demir, S.; Turan, R. D.; Abanuz, S.; Cakirsoy, D.; Seyis, U.; Ozer, S.; Elibol, O.; Elek, M.; Ertop, G.; Arbak, S.; Acikel Elmas, M.; Hemsinlioglu, C.; Kocagoz, A. S.; Hatirnaz Ng, O.; Akyoney, S.; Sahin, I.; Ozbek, U.; Telci, D.; Sahin, F.; Yalcin, K.; Ovali, E.

doi:10.1101/2020.09.04.277426

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bioRxiv · 10.1101/2020.09.04.277426

Preliminary report of preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates, SK-01 version 1 and OZG-3861 version 1

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Abstract

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 neutralization capacity in absence of the antibody-dependent enhancement feature, when considered in terms of T and B cell responses. Another important finding was that the presence of adjuvant was more important in T cell in comparison with B cell response. Vaccinated mice showed T cell response upon restimulation with whole inactivated SARS-CoV-2 or peptide pool. This study shows that the vaccines are effective and leads us to start the challenge test to investigate the gamma-irradiated inactivated vaccine candidates for infective SARS-CoV-2 virus in humanized ACE2+ mice.

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SIR KARAKUS, G., Tastan, C., Dilek Kancagi, D., Yurtsever, B., Tumentemur, G., Demir, S., Turan, R. D., Abanuz, S., Cakirsoy, D., Seyis, U., Ozer, S., Elibol, O., Elek, M., Ertop, G., Arbak, S., Acikel Elmas, M., Hemsinlioglu, C., Kocagoz, A. S., Hatirnaz Ng, O., Akyoney, S., Sahin, I., Ozbek, U., Telci, D., Sahin, F., Yalcin, K., Ovali, E.. 2020-09-04. Preliminary report of preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates, SK-01 version 1 and OZG-3861 version 1. https://doi.org/10.1101/2020.09.04.277426

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