Animal Pre-Clinical Study of an Inactivated SARS-CoV-2 Vaccine candidate (Osvid-19 ®): Immunogenicity, Protective, and Safety Aspects
Main Article Content
Keywords
immunogenicity, toxicology, vaccine
Abstract
Background: This study aimed to evaluate the outcomes of preclinical studies on the safety and immunogenicity of an inactivated COVID-19 vaccine candidate to warrant further clinical evaluation.
Methods: SARS-CoV-2 positive nasopharyngeal swab specimens were confirmed by real-time polymerase chain reaction and next-generation sequencing. The safety and immunogenicity tests of the COVID-19 vaccine were carried out in rats and Rhesus monkeys, and Balb/C mice and Rhesus monkeys, respectively.
Results: The candidate vaccine was well tolerated and induced promising levels of SARS-CoV-2–specific IgG1, IgG2a, and Granzyme B in Balb/C mice, and anti-SARS-CoV-2 spike IgG and neutralizing antibodies in Rhesus monkeys. Based on cVNT results, the inactivated vaccine in 0.5 and 1 μg/100 μL doses was able to induce a neutralizing effect against the SARS-CoV-2 virus up to a dilution of 1:512 and 1:1000. The protective efficacy of the vaccine candidate was challenged with 2 ×108 PFU of live viruses and confirmed by lung CT scan and histopathological evaluations compared to the control group. Repeated intramuscular injection of the candidate vaccine was generally well-tolerated in Rats and Rhesuses. No significant side effects were observed in rats injected with ten full human doses and in the Rhesus monkeys with three full human doses.
Conclusion: Based on the findings presented in this study, it is recommended that this vaccine be moved into human testing commencing with a phase I clinical trial.
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18. Zepp F. Principles of vaccine design—lessons from nature. Vaccine. 2010;28:C14–24.
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20. Mellet J, Pepper MS. A COVID-19 vaccine: big strides come with big challenges. Vaccines. 2021;9(1):39.
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37. Kar T, Narsaria U, Basak S, Deb D, Castiglione F, Mueller DM, et al. A candidate multi-epitope vaccine against SARS-CoV-2. Sci Rep. 2020;10(1):1–24.
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May 5, 2023
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How to Cite
Zohre Eftekhari, Seyed Dawood Mousavi Nasab, Ruhollah Dorostkar, Ali Akbar Pourfathollah, Mahyar Jeloudai Mamaghani, Seyed Mehdi Hassanzadeh, & Hooman Kaghazian. (2023). Animal Pre-Clinical Study of an Inactivated SARS-CoV-2 Vaccine candidate (Osvid-19 ®): Immunogenicity, Protective, and Safety Aspects. Journal of Population Therapeutics and Clinical Pharmacology, 30(9), 111-130. https://doi.org/10.47750/jptcp.2023.30.09.013
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All articles published in JPTCP are licensed under Copyright Creative Commons Attribution-NonCommercial 4.0 International License.
How to Cite
Zohre Eftekhari, Seyed Dawood Mousavi Nasab, Ruhollah Dorostkar, Ali Akbar Pourfathollah, Mahyar Jeloudai Mamaghani, Seyed Mehdi Hassanzadeh, & Hooman Kaghazian. (2023). Animal Pre-Clinical Study of an Inactivated SARS-CoV-2 Vaccine candidate (Osvid-19 ®): Immunogenicity, Protective, and Safety Aspects. Journal of Population Therapeutics and Clinical Pharmacology, 30(9), 111-130. https://doi.org/10.47750/jptcp.2023.30.09.013