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| Vaccine description | |
|---|---|
| Target | SARS-CoV-2 |
| Vaccine type | Protein subunit |
| Clinical data | |
| Trade names | Spikogen[1] |
| Routes of administration | Intramuscular |
| Legal status | |
| Legal status |
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| Identifiers | |
| CAS Number | |
| Part ofa series on the |
| COVID-19 pandemic |
|---|
|
Medical response |
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COVAX-19 (orSpikoGen) is a recombinant protein-basedCOVID-19 vaccine developed bySouth Australian-based biotech company Vaxine, in collaboration with CinnaGen, a private company with operations inWest Asia. It is underclinical trial in collaboration with theIranian companyCinnaGen.[3][4][5]
It requires two doses 21 days apart given byintramuscular injection.[4]
COVAX-19 is a recombinantprotein subunit.[6]
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]
| 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 | IRCT20150303021315N23Archived 11 July 2021 at theWayback 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] | |||||||
On 6 October 2021, Iran approved the vaccine for emergency use.[15]
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