In Vitro Evaluation of the Long-term Immune Status of Razi-Cov-Pars Vaccine

Document Type : Original Article

Authors

1 Department of Immunology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran.

2 Vaccine and Serum Research Institute, Education and Extension Organization, Karaj, Iran.

Abstract

Background: The Razi-Cov-Pars vaccine, a recombinant protein vaccine developed in Iran, has undergone evaluation in three dosage strengths across three clinical trial phases. In phase I, volunteers received one of three dosages (5, 10, and 20 μg) corresponding to low, medium, and high strengths. 
Materials and Methods: This study assessed the long-term in vitro immune status of the Razi-Cov-Pars vaccine by transferring lymphocyte supernatants (SN) from individuals vaccinated for 8 months to lymphocytes from individuals vaccinated for 16 months and non-vaccinated healthy individuals. Immunological parameters were evaluated using the 3-(4, 5-dimethyl thiazolyl-2)-2, 5-diphenyltetrazolium bromide assay for stimulation index and reverse transcription polymerase chain reaction for interleukin 10, transforming growth factor-ß (TGF-ß) and TGF-α levels.
Results: The findings revealed that lymphocyte SN from individuals vaccinated for 8 months significantly enhanced the proliferation of lymphocytes from individuals vaccinated for 16 months with the licensed 10 μg strength vaccine. This suggests that the Razi-Cov-Pars vaccine may have long-term effects on lymphocyte proliferation and immune response. Notably, there was a significant increase in TGF-α levels across all vaccine strengths, hinting at the potential role of TGF-α in long-term immune processes following vaccination with Razi-Cov-Pars. Additionally, there was a marked increase in interleukin-10 levels in all vaccinated groups, indicating active pro-inflammatory elements in the SN. TGF-β expression significantly increased in the high-strength vaccine group, whereas no notable difference was observed in the low and medium-strength groups.
Conclusion: We detected a significant stimulation in the lymphocytes isolated from vaccinated individuals after 16 months by measurement of proliferative potential and cytokine gene expression thereby assessing the long-term effect of the vaccine.

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