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COVAX-19
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COVAX-19

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COVAX-19
Vaccine description
Target SARS-CoV-2
Vaccine type Protein subunit
Clinical data
Trade names Spikogen
Routes of
administration
Intramuscular
Legal status
Legal status
  • Full and emergency authorisations
Full list of COVAX-19 authorisations

COVAX-19 (or SpikoGen) is the result of a collaboration between Vaxine and CinnaGen, a private company with operations in the Middle East. COVAX-19 is a recombinant protein-based COVID-19 vaccine developed by South Australian-based biotech company Vaxine. It is under clinical trial in collaboration with the Iranian company CinnaGen.

Medical uses

It requires two doses 21 days apart given by intramuscular injection.

Pharmacology

COVAX-19 is a recombinant protein subunit.

History

Vaxine began work on a COVID-19 vaccine in January 2020. After developing a number of different types of vaccines, 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.

Phases 2 and 3 clinical trials of COVAX-19 are being conducted in Iran under a co-operation agreement. 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, Vaxine will produce the vaccine under the name COVAX-19 in Australia and Cinnagen will produce the vaccine under the name SpikoGen in Iran.

Clinical trials

Clinical trials of COVAX-19 (SpikoGen)
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
II IRCT20150303021315N23 30 May 2021 400 300 100 18+ years Tehran, Iran
NCT04944368
III IRCT20150303021315N24 7 August 2021 16,876 12,657 4,219 18–50 years Tehran, Iran
NCT05005559

Authorisations

On 6 October 2021, Iran approved the vaccine for emergency use.

See also



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