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

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 lyophili...

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Autores principales: 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
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Publicado: Nature Portfolio 2021
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Acceso en línea:https://doaj.org/article/46a25aaed32541e28966db05d0693f25
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spelling oai:doaj.org-article:46a25aaed32541e28966db05d0693f252021-12-02T13:34:51ZPreclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates10.1038/s41598-021-83930-62045-2322https://doaj.org/article/46a25aaed32541e28966db05d0693f252021-03-01T00:00:00Zhttps://doi.org/10.1038/s41598-021-83930-6https://doaj.org/toc/2045-2322Abstract 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.Gozde Sir KarakusCihan TastanDerya Dilek KancagiBulut YurtseverGamze TumentemurSevda DemirRaife Dilek TuranSelen AbanuzDidem CakirsoyUtku SeyisSamed OzerOmer ElibolMuhammer ElekGurcan ErtopSerap ArbakMerve Acikel ElmasCansu HemsinliogluAyse Sesin KocagozOzden Hatirnaz NgSezer AkyoneyIlayda SahinUgur OzbekDilek TelciFikrettin SahinKoray YalcinSiret RatipErcument OvaliNature PortfolioarticleMedicineRScienceQENScientific Reports, Vol 11, Iss 1, Pp 1-19 (2021)
institution DOAJ
collection DOAJ
language EN
topic Medicine
R
Science
Q
spellingShingle Medicine
R
Science
Q
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
Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates
description 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.
format article
author 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
author_facet 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
author_sort Gozde Sir Karakus
title Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates
title_short Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates
title_full Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates
title_fullStr Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates
title_full_unstemmed Preclinical efficacy and safety analysis of gamma-irradiated inactivated SARS-CoV-2 vaccine candidates
title_sort preclinical efficacy and safety analysis of gamma-irradiated inactivated sars-cov-2 vaccine candidates
publisher Nature Portfolio
publishDate 2021
url https://doaj.org/article/46a25aaed32541e28966db05d0693f25
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