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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MDPI AG
2021
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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) |
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SARS-CoV-2 vaccine inactivated vaccine immunogenicity ERUCoV-VAC COVID-19 vaccine Medicine R |
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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 |
work_keys_str_mv |
AT shaikhterkisislampavel developmentofaninactivatedvaccineagainstsarscov2 AT hazelyetiskin developmentofaninactivatedvaccineagainstsarscov2 AT muhammetaliuygut developmentofaninactivatedvaccineagainstsarscov2 AT ahmetfurkanaslan developmentofaninactivatedvaccineagainstsarscov2 AT gunsuaydın developmentofaninactivatedvaccineagainstsarscov2 AT oznurinan developmentofaninactivatedvaccineagainstsarscov2 AT busrakaplan developmentofaninactivatedvaccineagainstsarscov2 AT aykutozdarendeli developmentofaninactivatedvaccineagainstsarscov2 |
_version_ |
1718410215582334976 |