Английская Википедия:COVAX-19
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
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
- COVID-19 vaccine clinical research
- COVID-19 pandemic in Australia
- COVID-19 pandemic in Iran
- Pharmaceuticals in Iran
References
Шаблон:Vaccines Шаблон:COVID-19 pandemic Шаблон:Portal bar
Шаблон:COVID19-vaccine-stub
Шаблон:Vaccine-stub