Английская Википедия:COVAX-19

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Шаблон:Short description Шаблон:EngvarB Шаблон:Use dmy dates Шаблон:Expand Persian Шаблон:Infobox drug Шаблон:COVID-19 pandemic sidebar 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.[1][2][3]

Medical uses

It requires two doses 21 days apart given by intramuscular injection.[2]

Pharmacology

COVAX-19 is a recombinant protein subunit.[4]

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.[5]

Phases 2 and 3 clinical trials of COVAX-19 are being conducted in Iran under a co-operation agreement.[6] 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.[5][7]

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 [8][9]
II IRCT20150303021315N23 30 May 2021 400 300 100 18+ years Tehran, Iran [10]
NCT04944368 [11]
III IRCT20150303021315N24 7 August 2021 16,876 12,657 4,219 18–50 years Tehran, Iran [2]
NCT05005559 [12]

Authorisations

Шаблон:See also On 6 October 2021, Iran approved the vaccine for emergency use.[13]

See also

References

Шаблон:Reflist

Шаблон:Scholia

Шаблон:Vaccines Шаблон:COVID-19 pandemic Шаблон:Portal bar


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