Vaccines (Nov 2021)

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

  • 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 Khodaeipour,
  • Moslem Papizadeh,
  • Roghayeh Najafi,
  • Ehsan Naghneh,
  • Davood Sadeghi,
  • Ahmad Karimi Rahjerdi

DOI
https://doi.org/10.3390/vaccines9111271
Journal volume & issue
Vol. 9, no. 11
p. 1271

Abstract

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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.

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