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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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 the Middle East. It is under clinical trial in collaboration with the Iranian company CinnaGen.[2][3][4]
It requires two doses 21 days apart given by intramuscular injection.[3]
COVAX-19 is a recombinant protein subunit.[5]
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.[6]
Phases 2 and 3 clinical trials of COVAX-19 are being conducted in Iran under a co-operation agreement.[7] 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.[6][8]
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 | [9][10] |
II | IRCT20150303021315N23 | 30 May 2021 | 400 | 300 | 100 | 18+ years | Tehran, Iran | [11] |
NCT04944368 | [12] | |||||||
III | IRCT20150303021315N24 | 7 August 2021 | 16,876 | 12,657 | 4,219 | 18–50 years | Tehran, Iran | [3] |
NCT05005559 | [13] |
See also: List of COVID-19 vaccine authorizations § COVAX-19 |
On 6 October 2021, Iran approved the vaccine for emergency use.[14]
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