Razi Cov Pars (Persian: رازی کوو پارس) is a COVID-19 vaccine developed by the Iranian Razi Vaccine and Serum Research Institute Razi Cov Pars is a covid-19 vaccine based on recombinant protein, which is being produced by Razi Vaccine and Serum Research Institute, Iran. This vaccine is the first injectable-intranasal recombinant protein corona vaccine.[1][2][3]It's the second Iranian COVID-19 vaccine reaching human trials[1] and is currently in phase III of clinical research during which it's compared to the Sinopharm BIBP vaccine.[4][5]
 | |
| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | Protein subunit |
| Clinical data | |
| Routes of administration | Intramuscular, Intranasal |
| Legal status | |
| Legal status | |
| Identifiers | |
| CAS Number | |
Medical uses
editIt requires three doses given day 0 (intramuscular), day 21 (intramuscular) and day 51 (intranasal spray).[3]
Pharmacology
editRazi Cov Pars is a recombinant protein subunit vaccine containing the SARS-CoV-2 spike protein.[2]
Manufacturing
editIt's planned to produce one million doses of the vaccine each month as of September 2021.[4]
As of 25 November 2021, 5 millions doses have been delivered to the Iranian Ministry of Health.[6]
History
editClinical trials
edit| Phase | Registration number | Start | Number of participants | Age of participants | Ref | ||
|---|---|---|---|---|---|---|---|
| Total | Vaccine | Placebo | |||||
| I | IRCT20201214049709N1 | 21 January 2021 | 133 | 30 (5 μg/200 μL)
30 (10 μg/200 μL) 30 (20 μg/200 μL) |
30 (placebo)
13 (sentinel) |
18-50 years | [2] |
| II | IRCT20201214049709N2 | 13 April 2021 | 500 | 18-70 years | [3] | ||
| III | IRCT20201214049709N3 | 29 August 2021 | 41,128 | 20,564 | 0 (placebo)
20,564 (Sinopharm BIBP vaccine) |
18+ years | [5] |
See also
editReferences
edit- ^ a b Banihashemi SR, Es-Haghi A, Fallah Mehrabadi MH, Nofeli M, Mokarram AR, Ranjbar A, et al. (26 May 2022). "Safety and Efficacy of Combined Intramuscular/Intranasal RAZI-COV PARS Vaccine Candidate Against SARS-CoV-2: A Preclinical Study in Several Animal Models". Frontiers in Immunology. 13: 836745. doi:10.3389/fimmu.2022.836745. PMC 9179012. PMID 35693788.
- ^ a b c "Phase I, Safety and Immunogenicity of Razi SARS-CoV-2 recombinant Spike protein vaccine (Razi Cov Pars), in healthy adults aged 18-55 years; parallel 4 arms design (adjuvant only and three vaccine doses of 5, 10, and 20 μg/200 μL); a Randomised, double blind, clinical trial". irct.ir. Iranian Registry of Clinical Trials. Retrieved 21 March 2021.
- ^ a b c "Phase II, Safety and Immunogenicity of RAZI SARS-CoV-2 recombinant Spike protein vaccine (RAZI Cov Pars) in adults aged 18-70 years; a Randomised, double blind, parallel 2 arms clinical trial". Iranian Registry of Clinical Trials. Retrieved 22 April 2021.
- ^ a b "COVID-19 vaccine Razi Cov Pars starts third clinical trial phase". Tehran Times. 27 August 2021. Retrieved 30 August 2021.
- ^ a b "IRCT | Comparison of the safety and efficacy of Razi SARS-CoV-2 recombinant Spike protein (Razi Cov Pars) and Sinopharm vaccines in adults aged 18 and over, a phase III randomised, double blind, non-inferiority clinical trial". en.irct.ir. Retrieved 30 August 2021.
- ^ "۵ میلیون دز واکسن رازی به وزارت بهداشت تحویل داده شد" [5 million doses of Razi vaccine were delivered to the Ministry of Health]. ایسنا(ISNA) (in Persian). 25 November 2021. Retrieved 27 November 2021.
Further reading
edit- Mohazzab A, Fallah Mehrabadi MH, Es-Haghi A, Kalantari S, Mokhberalsafa L, Setarehdan SA, et al. (December 2023). "Phase II, Safety and Immunogenicity of RAZI Cov Pars (RCP) SARS Cov-2 Vaccine in Adults Aged 18-70 Years; A Randomized, Double-Blind Clinical Trial". Journal of Pharmaceutical Sciences. 112 (12): 3012–3021. doi:10.1016/j.xphs.2023.09.027. PMID 37832918.
- Erfanpoor S, Banihashemi SR, Mokhbaeralsafa L, Kalantari S, Es-Haghi A, Nofeli M, et al. (February 2024). "Immunogenicity and safety of RAZI recombinant spike protein vaccine (RCP) as a booster dose after priming with BBIBP-CorV: a parallel two groups, randomized, double blind trial". BMC Medicine. 22 (1): 78. doi:10.1186/s12916-024-03295-1. PMC 10877779. PMID 38378570.
- Solaymani-Dodaran M, Kalantari S, Banihashemi SR, Es-Haghi A, Nofeli M, Mohazzab A, et al. (March 2024). "Safety and efficacy of RCP recombinant spike protein covid-19 vaccine compared to Sinopharm BBIBP: A phase III, non-inferiority trial". Heliyon. 10 (5): e27370. Bibcode:2024Heliy..1027370S. doi:10.1016/j.heliyon.2024.e27370. PMC 10923712. PMID 38463808.
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