COVAX-19
From Wikipedia, the free encyclopedia
Vaccine candidate against COVID-19
Pharmaceutical compound
TargetSARS-CoV-2
Trade namesSpikogen[1]
| Vaccine description | |
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| Target | SARS-CoV-2 |
| Vaccine type | Protein subunit |
| Clinical data | |
| Trade names | Spikogen[1] |
| Routes of administration | Intramuscular |
| Legal status | |
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| Part of a series on the |
| COVID-19 pandemic |
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.svg){kind=small} COVID-19 portal |
COVAX-19 (or SpikoGen) is a recombinant protein-based COVID-19 vaccine developed by South Australian-based biotech company Vaxine, in collaboration with CinnaGen, a private company with operations in West Asia. It is under clinical trial in collaboration with the Iranian company CinnaGen.[3][4][5]
It requires two doses 21 days apart given by intramuscular injection.[4]
Pharmacology
COVAX-19 is a recombinant protein subunit.[6]
History
Vaxine began work on a COVID-19 vaccine in January 2020. After developing a vaccine adjuvant the company decided to focus on a "recombinant protein-based vaccine". A phase 1 human trial started in June 2020. The phase 1 trial involved 40 participants, 30 of whom received the vaccine. The remaining ten participants received a saline placebo.[7]
Phases 2 and 3 clinical trials of COVAX-19 are being conducted in Iran under a co-operation agreement.[8] Phase 2 clinical trials started in May 2021 and Phase 3 trials commenced in August 2021. In the phase 2 trials, 400 Iranian volunteers were injected with either a placebo or the first dose of the vaccine. If the studies are successful, Cinnagen will produce the vaccine under the name SpikoGen in Iran.[7][9]
Clinical trials
| Phase | Registration number | Start | Number of participants | Age of participants | Location | Ref | ||
|---|---|---|---|---|---|---|---|---|
| Total | Vaccine | Placebo | ||||||
| I | NCT04453852 | 30 June 2020 | 40 | 30 | 10 | 18–65 years | Adelaide, Australia | [10][11] |
| II | IRCT20150303021315N23 Archived 11 July 2021 at the Wayback Machine | 30 May 2021 | 400 | 300 | 100 | 18+ years | Tehran, Iran | [12] |
| NCT04944368 | [13] | |||||||
| III | IRCT20150303021315N24 | 7 August 2021 | 16,876 | 12,657 | 4,219 | 18–50 years | Tehran, Iran | [4] |
| NCT05005559 | [14] | |||||||
Authorisations
On 6 October 2021, Iran approved the vaccine for emergency use.[15]
See also
References
- ↑ Clinical trial number NCT04944368 for "Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)" at ClinicalTrials.gov
- ↑ "Patent Landscape Report COVID-19-related vaccines and therapeutics" (PDF).
- ↑ ""Spikogen", A Joint Venture Between Vaxine And Cinnagen". Vaxine. Archived from the original on 11 July 2021. Retrieved 28 July 2021.
- 1 2 3 "A phase III, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. (Two doses of 25 μg with dosing interval of 21 days)". irct.ir. 2 August 2021. IRCT20150303021315N24. Archived from the original on 3 August 2021. Retrieved 3 August 2021.
- ↑ Griffin P (23 June 2021). "What is COVAX-19? Australia's most advanced COVID vaccine candidate". medicine.uq.edu.au. Retrieved 5 August 2021.
- ↑ Clinical trial number NCT04453852 for "Monovalent Recombinant COVID19 Vaccine (COVAX19)" at ClinicalTrials.gov
- 1 2 Griffin, Paul (23 June 2021). "What is COVAX-19, the most advanced of Australia's remaining local COVID vaccine candidates?". The Conversation. Retrieved 15 November 2021.
- ↑ ""SpikoGen", a joint venture between Vaxine and CinnaGen – Vaxine". Archived from the original on 11 July 2021. Retrieved 28 July 2021.
- ↑ "CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine's COVID-19 Vaccine Technology – Vaxine". Archived from the original on 15 November 2021. Retrieved 15 November 2021.
- ↑ Vaxine Pty Ltd (5 May 2021). "A Randomised, Controlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Adjuvanted Recombinant Protein SARS-COV-2 Vaccine in Healthy Adult Subjects". Central Adelaide Local Health Network Incorporated.
- ↑ "چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen" (in Persian). 26 April 2020. Archived from the original on 9 July 2021. Retrieved 7 September 2021.
- ↑ "IRCT | A phase II, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen) produced by CinnaGen Co. (Two doses of 25 μg with dosing interval of 21 days)". en.irct.ir. Archived from the original on 11 July 2021. Retrieved 7 September 2021.
- ↑ Cinnagen (14 August 2021). "A Phase II, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)". Vaxine Pty Ltd.
- ↑ Cinnagen (11 August 2021). "A Phase III, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen)". Vaxine Pty Ltd.
- ↑ "Iran issues emergency permit for new local Covid-19 vaccine". Mehr News Agency. 6 October 2021. Retrieved 11 October 2021.
Scholia has a profile for COVAX-19 (Q107864269).
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