학술논문

Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates.
Document Type
Academic Journal
Author
Sir Karakus G; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Tastan C; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Molecular Biology and Genetics Department, Uskudar University, Istanbul, Turkey.; Dilek Kancagi D; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Yurtsever B; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Tumentemur G; Vocational School of Health Services, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Demir S; Genetic and Bioengineering Department, Yeditepe University, Istanbul, Turkey.; Turan RD; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Genetic and Bioengineering Department, Yeditepe University, Istanbul, Turkey.; Abanuz S; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Medical Biochemistry Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Cakirsoy D; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Medical Biotechnology Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Seyis U; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Ozer S; Animal Application and Research Center, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Elibol O; Acibadem Altunizade Hospital, Istanbul, Turkey.; Elek M; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Genetic and Bioengineering Department, Yeditepe University, Istanbul, Turkey.; Ertop G; Vocational School of Health Services, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Arbak S; Histology and Embryology Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Acikel Elmas M; Histology and Embryology Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Hemsinlioglu C; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Kocagoz AS; Acibadem Altunizade Hospital, Infectious Disease Unit, Istanbul, Turkey.; Hatirnaz Ng O; Medical Biology Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Akyoney S; Medical Biology Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Biostatistics and Bioinformatics Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Sahin I; Medical Biotechnology Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Medical Genetics Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Ozbek U; Medical Genetics Department, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Telci D; Genetic and Bioengineering Department, Yeditepe University, Istanbul, Turkey.; Sahin F; Genetic and Bioengineering Department, Yeditepe University, Istanbul, Turkey.; Yalcin K; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey.; Medical Park Goztepe Hospital, Pediatric Bone Marrow Transplantation Unit, Istanbul, Turkey.; Ratip S; Hematology Department, School of Medicine, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.; Ovali E; Acibadem Labcell Cellular Therapy Laboratory, Istanbul, Turkey. ercument.ovali@acibadem.com.
Source
Publisher: Nature Publishing Group Country of Publication: England NLM ID: 101563288 Publication Model: Electronic Cited Medium: Internet ISSN: 2045-2322 (Electronic) Linking ISSN: 20452322 NLM ISO Abbreviation: Sci Rep Subsets: MEDLINE
Subject
Language
English
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.