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

Abstract

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.

Comparison of the Safety and Immunogenicity of FAKHRAVAC and BBIBP-CorV Vaccines when Administrated as Booster Dose: A Parallel Two Arms, Randomized, Double Blind Clinical Trial

“…The BBIBP-CorV (also known as Sinopharm or BIBP, developed by Sinopharm's Beijing Institute of Biological Products: BIBP) is one of the first vaccines listed in EUL [6], which has been approved in 91 countries and also tested in 30 trials among 12 countries [7]. The FAKHRAVAC ® is an inactivated vaccine with seeds isolated from oropharynx swabs of confirmed COVID-19 patients admitted to Iranian hospitals, which was developed by Milad Darou Noor Pharmaceutical Company (MDNP) [8]. This vaccine is currently licensed for emergency use in Iran, and its validation process via a third-phase clinical trial is developing to the later steps.…”

Towards novel nano-based vaccine platforms for SARS-CoV-2 and its variants of concern: Advances, challenges and limitations

“… [ 8 , 47 ] FAKHRAVAC (MIVAC) Organization of Defensive Innovation & Research, Iran. IM NA NA Phase 3 Iran NR [ 8 , 48 ] KCONVAC (KconecaVac) Minhai Biotech, China. IM ○ Vero monkey cells NA Phase 3 China NR [ 3 , 8 , 103 ] Indonesia QazVac Research Institute for Biological Safety Problems, Kazakhstan.…”

Aptamer-based diagnosis of various SARS-CoV2 strains isolated from clinical specimens

“…According to two described models by Gu et al(6), graphene oxide was used to isolate free aptamers with low binding a nity in each round of SELEX with higher e ciency 6 . In brief, after denaturation of the initial DNA library under thermal shock, in the model I, the ssDNA pool was incubated with SARS-COV-2 inactivated virus obtained from Fakhra Co., Iran 7 . Then, GO was added, and after centrifugation, the supernatant containing bounded ssDNA to the virus was used for PCR assay.…”