Medicine:COVAX-19
| Vaccine description | |
|---|---|
| Target disease | SARS-CoV-2 |
| Type | Protein subunit |
| Clinical data | |
| Trade names | Spikogen[1] |
| Routes of administration | Intramuscular |
| Legal status | |
| Legal status |
|
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.[2][3][4]
Medical uses
It requires two doses 21 days apart given by intramuscular injection.[3]
Pharmacology
COVAX-19 is a recombinant protein subunit.[5]
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.[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]
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 | [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] | |||||||
Authorisations
On 6 October 2021, Iran approved the vaccine for emergency use.[14]
See also
- COVID-19 vaccine clinical research
- COVID-19 pandemic in Australia
- COVID-19 pandemic in Iran
- Pharmaceuticals in Iran
References
- ↑ Clinical trial number NCT04944368 for "Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)" at ClinicalTrials.gov
- ↑ ""Spikogen", A Joint Venture Between Vaxine And Cinnagen". Vaxine. https://vaxine.net/spikogen-a-joint-venture-between-vaxine-and-cinnagen/.
- ↑ 3.0 3.1 3.2 "A phase III, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen®) produced by CinnaGen Co. (Two doses of 25µg with dosing interval of 21 days)". 2 August 2021. https://www.irct.ir/trial/57559.
- ↑ "What is COVAX-19? Australia's most advanced COVID vaccine candidate" (in en). 23 June 2021. https://medicine.uq.edu.au/article/2021/06/what-covax-19-australias-most-advanced-covid-vaccine%C2%A0candidate.
- ↑ Clinical trial number NCT04453852 for "Monovalent Recombinant COVID19 Vaccine (COVAX19)" at ClinicalTrials.gov
- ↑ 6.0 6.1 Griffin, Paul (23 June 2021). "What is COVAX-19, the most advanced of Australia's remaining local COVID vaccine candidates?" (in en). https://theconversation.com/what-is-covax-19-the-most-advanced-of-australias-remaining-local-covid-vaccine-candidates-162347.
- ↑ ""SpikoGen®", a joint venture between Vaxine and CinnaGen – Vaxine". https://vaxine.net/spikogen-a-joint-venture-between-vaxine-and-cinnagen/.
- ↑ "CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine's COVID-19 Vaccine Technology – Vaxine". https://vaxine.net/vaxine-and-cinnagen-initiated-a-phase-3-clinical-trial-for-their-covid-19-vaccine-candidate/.
- ↑ Vaxine Pty Ltd (5 May 2021). A Randomised, Controlled, Phase 1 Study to Evaluate the Safety and Immunogenicity of a Candidate Adjuvanted Recombinant Protein SARS-COV-2 Vaccine in Healthy Adult Subjects. Central Adelaide Local Health Network Incorporated. https://clinicaltrials.gov/ct2/show/NCT04453852.
- ↑ "چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen" (in fa-IR). 26 April 2020. https://spikogen.com/why-spikogen/.
- ↑ "IRCT | A phase II, Randomized, Two-armed, Double-blind, Placebo controlled trial to evaluate efficacy and safety of an adjuvanted recombinant SARS-CoV-2 spike (S) protein subunit vaccine (SpikoGen®) produced by CinnaGen Co. (Two doses of 25µg with dosing interval of 21 days)". https://en.irct.ir/trial/56287.
- ↑ Cinnagen (14 August 2021). A Phase II, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen). Vaxine Pty Ltd. https://clinicaltrials.gov/ct2/show/NCT04944368.
- ↑ Cinnagen (11 August 2021). A Phase III, Randomized, Two-armed, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy and Safety of an Adjuvanted Recombinant SARS-CoV-2 Spike (S) Protein Subunit Vaccine Candidate (SpikoGen). Vaxine Pty Ltd. https://clinicaltrials.gov/ct2/show/NCT05005559.
- ↑ "Iran issues emergency permit for new local Covid-19 vaccine". Mehr News Agency. 6 October 2021. https://en.mehrnews.com/news/179432/Iran-issues-emergency-permit-for-new-local-Covid-19-vaccine.
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