Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates

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作者
Gozde Sir Karakus
Cihan Tastan
Derya Dilek Kancagi
Bulut Yurtsever
Gamze Tumentemur
Sevda Demir
Raife Dilek Turan
Selen Abanuz
Didem Cakirsoy
Utku Seyis
Samed Ozer
Omer Elibol
Muhammer Elek
Gurcan Ertop
Serap Arbak
Merve Acikel Elmas
Cansu Hemsinlioglu
Ayse Sesin Kocagoz
Ozden Hatirnaz Ng
Sezer Akyoney
Ilayda Sahin
Ugur Ozbek
Dilek Telci
Fikrettin Sahin
Koray Yalcin
Siret Ratip
Ercument Ovali
机构
[1] Acibadem Labcell Cellular Therapy Laboratory,Molecular Biology and Genetics Department
[2] Uskudar University,Vocational School of Health Services
[3] Acibadem Mehmet Ali Aydinlar University,Genetic and Bioengineering Department
[4] Yeditepe University,Animal Application and Research Center
[5] Acibadem Mehmet Ali Aydinlar University,Histology and Embryology Department
[6] Acibadem Altunizade Hospital,Medical Biology Department
[7] Acibadem Mehmet Ali Aydinlar University,Biostatistics and Bioinformatics Department
[8] Acibadem Altunizade Hospital,Medical Biotechnology Department
[9] Infectious Disease Unit,Medical Genetics Department
[10] Acibadem Mehmet Ali Aydinlar University,Medical Park Goztepe Hospital
[11] Acibadem Mehmet Ali Aydinlar University,Medical Biochemistry Department
[12] Acibadem Mehmet Ali Aydinlar University,Hematology Department, School of Medicine
[13] Acibadem Mehmet Ali Aydinlar University,undefined
[14] Pediatric Bone Marrow Transplantation Unit,undefined
[15] Acibadem Mehmet Ali Aydinlar University,undefined
[16] Acibadem Mehmet Ali Aydinlar University,undefined
来源
Scientific Reports | / 11卷
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摘要
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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