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Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates. 2021
Gozde Sir Karakus, and
Cihan Tastan, and
Derya Dilek Kancagi, and
Bulut Yurtsever, and
Gamze Tumentemur, and
Sevda Demir, and
Raife Dilek Turan, and
Selen Abanuz, and
Didem Cakirsoy, and
Utku Seyis, and
Samed Ozer, and
Omer Elibol, and
Muhammer Elek, and
Gurcan Ertop, and
Serap Arbak, and
Merve Acikel Elmas, and
Cansu Hemsinlioglu, and
Ayse Sesin Kocagoz, and
Ozden Hatirnaz Ng, and
Sezer Akyoney, and
Ilayda Sahin, and
Ugur Ozbek, and
Dilek Telci, and
Fikrettin Sahin, and
Koray Yalcin, and
Siret Ratip, and
Ercument Ovali
Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.
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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