Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models

The recent viral infection disease pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in a global public health crisis. Iran, as one of the countries that reported over five million infected cases by September 2021, has been concerned with the urgent devel...

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Autores principales:	Soheil Ghasemi, Kosar Naderi Saffar, Firooz Ebrahimi, Pezhman Khatami, Arina Monazah, Ghorban-Ali Alizadeh, Hossein-Ali Ettehadi, Iman Rad, Shahrzad Nojehdehi, Mousa Kehtari, Fatemeh Kouhkan, Hesam Barjasteh, Sohrab Moradi, Mohammad-Hosein Ghorbani, Ali Khodaie, Moslem Papizadeh, Roghayeh Najafi, Ehsan Naghneh, Davood Sadeghi, Ahmad Karimi Rahjerdi
Formato:	article
Lenguaje:	EN
Publicado:	MDPI AG 2021
Materias:	SARS-CoV-2 vaccine candidate FAKHRAVAC COVID-19 Medicine R
Acceso en línea:	https://doaj.org/article/4029ad1958be4e4ea152650fa4f5f074
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spelling	oai:doaj.org-article:4029ad1958be4e4ea152650fa4f5f0742021-11-25T19:10:49ZDevelopment of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models10.3390/vaccines91112712076-393Xhttps://doaj.org/article/4029ad1958be4e4ea152650fa4f5f0742021-11-01T00:00:00Zhttps://www.mdpi.com/2076-393X/9/11/1271https://doaj.org/toc/2076-393XThe recent viral infection disease pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in a global public health crisis. Iran, as one of the countries that reported over five million infected cases by September 2021, has been concerned with the urgent development of effective vaccines against SARS-CoV-2. In this paper, we report the results of a study on potency and safety of an inactivated SARS-CoV-2 vaccine candidate (FAKHRAVAC) in a preclinical study so as to confirm its potential for further clinical evaluation. Here, we developed a pilot-scale production of FAKHRAVAC, a purified inactivated SARS-CoV-2 virus vaccine candidate that induces neutralizing antibodies in Balb/c mice, guinea pigs, rabbits, and non-human primates (Rhesus macaques—RM). After obtaining ethical code of IR.IUMS.REC.1399.566, immunizations of animals were conducted by using either of three different vaccine dilutions; High (H): 10 μg/dose, Medium (M): 5 μg/dose, and Low (L): 1 μg/dose, respectively. In the process of screening for viral seeds, viral strains that resulted in the most severe clinical manifestation in patients have been isolated for vaccine development. The viral seed produced the optimal immunity against SARS-CoV-2 virus, which suggests a possible broader neutralizing ability against SARS-CoV-2 strains. The seroconversion rate at the H-, M-, and L-dose groups of all tested animals reached 100% by 28 days after immunization. These data support the eligibility of FAKHRAVAC vaccine candidate for further evaluation in a clinical trial.Soheil GhasemiKosar Naderi SaffarFirooz EbrahimiPezhman KhatamiArina MonazahGhorban-Ali AlizadehHossein-Ali EttehadiIman RadShahrzad NojehdehiMousa KehtariFatemeh KouhkanHesam BarjastehSohrab MoradiMohammad-Hosein GhorbaniAli KhodaieMoslem PapizadehRoghayeh NajafiEhsan NaghnehDavood SadeghiAhmad Karimi RahjerdiMDPI AGarticleSARS-CoV-2vaccine candidateFAKHRAVACCOVID-19MedicineRENVaccines, Vol 9, Iss 1271, p 1271 (2021)
institution	DOAJ
collection	DOAJ
language	EN
topic	SARS-CoV-2 vaccine candidate FAKHRAVAC COVID-19 Medicine R
spellingShingle	SARS-CoV-2 vaccine candidate FAKHRAVAC COVID-19 Medicine R Soheil Ghasemi Kosar Naderi Saffar Firooz Ebrahimi Pezhman Khatami Arina Monazah Ghorban-Ali Alizadeh Hossein-Ali Ettehadi Iman Rad Shahrzad Nojehdehi Mousa Kehtari Fatemeh Kouhkan Hesam Barjasteh Sohrab Moradi Mohammad-Hosein Ghorbani Ali Khodaie Moslem Papizadeh Roghayeh Najafi Ehsan Naghneh Davood Sadeghi Ahmad Karimi Rahjerdi Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models
description	The recent viral infection disease pandemic, caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), has resulted in a global public health crisis. Iran, as one of the countries that reported over five million infected cases by September 2021, has been concerned with the urgent development of effective vaccines against SARS-CoV-2. In this paper, we report the results of a study on potency and safety of an inactivated SARS-CoV-2 vaccine candidate (FAKHRAVAC) in a preclinical study so as to confirm its potential for further clinical evaluation. Here, we developed a pilot-scale production of FAKHRAVAC, a purified inactivated SARS-CoV-2 virus vaccine candidate that induces neutralizing antibodies in Balb/c mice, guinea pigs, rabbits, and non-human primates (Rhesus macaques—RM). After obtaining ethical code of IR.IUMS.REC.1399.566, immunizations of animals were conducted by using either of three different vaccine dilutions; High (H): 10 μg/dose, Medium (M): 5 μg/dose, and Low (L): 1 μg/dose, respectively. In the process of screening for viral seeds, viral strains that resulted in the most severe clinical manifestation in patients have been isolated for vaccine development. The viral seed produced the optimal immunity against SARS-CoV-2 virus, which suggests a possible broader neutralizing ability against SARS-CoV-2 strains. The seroconversion rate at the H-, M-, and L-dose groups of all tested animals reached 100% by 28 days after immunization. These data support the eligibility of FAKHRAVAC vaccine candidate for further evaluation in a clinical trial.
format	article
author	Soheil Ghasemi Kosar Naderi Saffar Firooz Ebrahimi Pezhman Khatami Arina Monazah Ghorban-Ali Alizadeh Hossein-Ali Ettehadi Iman Rad Shahrzad Nojehdehi Mousa Kehtari Fatemeh Kouhkan Hesam Barjasteh Sohrab Moradi Mohammad-Hosein Ghorbani Ali Khodaie Moslem Papizadeh Roghayeh Najafi Ehsan Naghneh Davood Sadeghi Ahmad Karimi Rahjerdi
author_facet	Soheil Ghasemi Kosar Naderi Saffar Firooz Ebrahimi Pezhman Khatami Arina Monazah Ghorban-Ali Alizadeh Hossein-Ali Ettehadi Iman Rad Shahrzad Nojehdehi Mousa Kehtari Fatemeh Kouhkan Hesam Barjasteh Sohrab Moradi Mohammad-Hosein Ghorbani Ali Khodaie Moslem Papizadeh Roghayeh Najafi Ehsan Naghneh Davood Sadeghi Ahmad Karimi Rahjerdi
author_sort	Soheil Ghasemi
title	Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models
title_short	Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models
title_full	Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models
title_fullStr	Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models
title_full_unstemmed	Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models
title_sort	development of inactivated fakhravac<sup>®</sup> vaccine against sars-cov-2 virus: preclinical study in animal models
publisher	MDPI AG
publishDate	2021
url	https://doaj.org/article/4029ad1958be4e4ea152650fa4f5f074
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Development of Inactivated FAKHRAVAC<sup>®</sup> Vaccine against SARS-CoV-2 Virus: Preclinical Study in Animal Models

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