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

Autor:	Ahmad Karimi Rahjerdi, Davood Sadeghi, Ghorban-Ali Alizadeh, Iman Rad, Ali Khodaie, Hesam Barjasteh, Fatemeh Kouhkan, Shahrzad Nojehdehi, Soheil Ghasemi, Kosar Naderi Saffar, Pezhman Khatami, Mohammad-Hosein Ghorbani, Moslem Papizadeh, Ehsan Naghneh, Hossein-Ali Ettehadi, Roghayeh Najafi, Mousa Kehtari, Sohrab Moradi, Firooz Ebrahimi, Arina Monazah
Rok vydání:	2021
Předmět:	vaccine candidate viruses Immunology Virus Immunity Drug Discovery Pandemic Medicine Potency Pharmacology (medical) Seroconversion FAKHRAVAC Pharmacology biology SARS-CoV-2 business.industry COVID-19 Virology Clinical trial Infectious Diseases Immunization biology.protein Antibody business
Zdroj:	Vaccines; Volume 9; Issue 11; Pages: 1271 Vaccines, Vol 9, Iss 1271, p 1271 (2021)
ISSN:	2076-393X
Popis:	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.
Databáze:	OpenAIRE
Externí odkaz:	https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1b9cfb4f8374abb01140321480f62467 https://doi.org/10.3390/vaccines9111271 Zobrazit plný text záznamu