Development of an Inactivated Vaccine against SARS CoV-2

The rapid spread of SARS-CoV-2 with its mutating strains has posed a global threat to safety during this COVID-19 pandemic. Thus far, there are 123 candidate vaccines in human clinical trials and more than 190 candidates in preclinical development worldwide as per the WHO on 1 October 2021. The vari...

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Autores principales: Shaikh Terkis Islam Pavel, Hazel Yetiskin, Muhammet Ali Uygut, Ahmet Furkan Aslan, Günsu Aydın, Öznur İnan, Büşra Kaplan, Aykut Ozdarendeli
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Publicado: MDPI AG 2021
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spelling oai:doaj.org-article:4fffaa2b7df34c4dbd3ef7efa5cc7fbf2021-11-25T19:10:44ZDevelopment of an Inactivated Vaccine against SARS CoV-210.3390/vaccines91112662076-393Xhttps://doaj.org/article/4fffaa2b7df34c4dbd3ef7efa5cc7fbf2021-11-01T00:00:00Zhttps://www.mdpi.com/2076-393X/9/11/1266https://doaj.org/toc/2076-393XThe rapid spread of SARS-CoV-2 with its mutating strains has posed a global threat to safety during this COVID-19 pandemic. Thus far, there are 123 candidate vaccines in human clinical trials and more than 190 candidates in preclinical development worldwide as per the WHO on 1 October 2021. The various types of vaccines that are currently approved for emergency use include viral vectors (e.g., adenovirus, University of Oxford/AstraZeneca, Gamaleya Sputnik V, and Johnson & Johnson), mRNA (Moderna and Pfizer-BioNTech), and whole inactivated (Sinovac Biotech and Sinopharm) vaccines. Amidst the emerging cases and shortages of vaccines for global distribution, it is vital to develop a vaccine candidate that recapitulates the severe and fatal progression of COVID-19 and further helps to cope with the current outbreak. Hence, we present the preclinical immunogenicity, protective efficacy, and safety evaluation of a whole-virion inactivated SARS-CoV-2 vaccine candidate (ERUCoV-VAC) formulated in aluminium hydroxide, in three animal models, BALB/c mice, transgenic mice (K18-hACE2), and ferrets. The hCoV-19/Turkey/ERAGEM-001/2020 strain was used for the safety evaluation of ERUCoV-VAC. It was found that ERUCoV-VAC was highly immunogenic and elicited a strong immune response in BALB/c mice. The protective efficacy of the vaccine in K18-hACE2 showed that ERUCoV-VAC induced complete protection of the mice from a lethal SARS-CoV-2 challenge. Similar viral clearance rates with the safety evaluation of the vaccine in upper respiratory tracts were also positively appreciable in the ferret models. ERUCoV-VAC has been authorized by the Turkish Medicines and Medical Devices Agency and has now entered phase 3 clinical development (NCT04942405). The name of ERUCoV-VAC has been changed to TURKOVAC in the phase 3 clinical trial.Shaikh Terkis Islam PavelHazel YetiskinMuhammet Ali UygutAhmet Furkan AslanGünsu AydınÖznur İnanBüşra KaplanAykut OzdarendeliMDPI AGarticleSARS-CoV-2vaccineinactivated vaccineimmunogenicityERUCoV-VACCOVID-19 vaccineMedicineRENVaccines, Vol 9, Iss 1266, p 1266 (2021)
institution DOAJ
collection DOAJ
language EN
topic SARS-CoV-2
vaccine
inactivated vaccine
immunogenicity
ERUCoV-VAC
COVID-19 vaccine
Medicine
R
spellingShingle SARS-CoV-2
vaccine
inactivated vaccine
immunogenicity
ERUCoV-VAC
COVID-19 vaccine
Medicine
R
Shaikh Terkis Islam Pavel
Hazel Yetiskin
Muhammet Ali Uygut
Ahmet Furkan Aslan
Günsu Aydın
Öznur İnan
Büşra Kaplan
Aykut Ozdarendeli
Development of an Inactivated Vaccine against SARS CoV-2
description The rapid spread of SARS-CoV-2 with its mutating strains has posed a global threat to safety during this COVID-19 pandemic. Thus far, there are 123 candidate vaccines in human clinical trials and more than 190 candidates in preclinical development worldwide as per the WHO on 1 October 2021. The various types of vaccines that are currently approved for emergency use include viral vectors (e.g., adenovirus, University of Oxford/AstraZeneca, Gamaleya Sputnik V, and Johnson & Johnson), mRNA (Moderna and Pfizer-BioNTech), and whole inactivated (Sinovac Biotech and Sinopharm) vaccines. Amidst the emerging cases and shortages of vaccines for global distribution, it is vital to develop a vaccine candidate that recapitulates the severe and fatal progression of COVID-19 and further helps to cope with the current outbreak. Hence, we present the preclinical immunogenicity, protective efficacy, and safety evaluation of a whole-virion inactivated SARS-CoV-2 vaccine candidate (ERUCoV-VAC) formulated in aluminium hydroxide, in three animal models, BALB/c mice, transgenic mice (K18-hACE2), and ferrets. The hCoV-19/Turkey/ERAGEM-001/2020 strain was used for the safety evaluation of ERUCoV-VAC. It was found that ERUCoV-VAC was highly immunogenic and elicited a strong immune response in BALB/c mice. The protective efficacy of the vaccine in K18-hACE2 showed that ERUCoV-VAC induced complete protection of the mice from a lethal SARS-CoV-2 challenge. Similar viral clearance rates with the safety evaluation of the vaccine in upper respiratory tracts were also positively appreciable in the ferret models. ERUCoV-VAC has been authorized by the Turkish Medicines and Medical Devices Agency and has now entered phase 3 clinical development (NCT04942405). The name of ERUCoV-VAC has been changed to TURKOVAC in the phase 3 clinical trial.
format article
author Shaikh Terkis Islam Pavel
Hazel Yetiskin
Muhammet Ali Uygut
Ahmet Furkan Aslan
Günsu Aydın
Öznur İnan
Büşra Kaplan
Aykut Ozdarendeli
author_facet Shaikh Terkis Islam Pavel
Hazel Yetiskin
Muhammet Ali Uygut
Ahmet Furkan Aslan
Günsu Aydın
Öznur İnan
Büşra Kaplan
Aykut Ozdarendeli
author_sort Shaikh Terkis Islam Pavel
title Development of an Inactivated Vaccine against SARS CoV-2
title_short Development of an Inactivated Vaccine against SARS CoV-2
title_full Development of an Inactivated Vaccine against SARS CoV-2
title_fullStr Development of an Inactivated Vaccine against SARS CoV-2
title_full_unstemmed Development of an Inactivated Vaccine against SARS CoV-2
title_sort development of an inactivated vaccine against sars cov-2
publisher MDPI AG
publishDate 2021
url https://doaj.org/article/4fffaa2b7df34c4dbd3ef7efa5cc7fbf
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