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COVAX-19

COVAX-19
Vaccine description
TargetSARS-CoV-2
Vaccine typeProtein subunit
Clinical data
Trade namesSpikogen[1]
Routes of
administration		Intramuscular
Legal status
Legal status
  • Full and emergency authorisations
Full list of COVAX-19 authorisations
Identifiers
CAS Number
Part of a series on the
COVID-19 pandemic
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
Scientifically accurate atomic model of the external structure of SARS-CoV-2. Each "ball" is an atom.
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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.[3][4][5]

Medical uses

It requires two doses 21 days apart given by intramuscular injection.[4]

Pharmacology

COVAX-19 is a recombinant protein subunit.[6]

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.[7]

Phases 2 and 3 clinical trials of COVAX-19 are being conducted in Iran under a co-operation agreement.[8] 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.[7][9]

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 [10][11]
II IRCT20150303021315N23 30 May 2021 400 300 100 18+ years Tehran, Iran [12]
NCT04944368 [13]
III IRCT20150303021315N24 7 August 2021 16,876 12,657 4,219 18–50 years Tehran, Iran [4]
NCT05005559 [14]

Authorisations

See also: List of COVID-19 vaccine authorizations § COVAX-19

On 6 October 2021, Iran approved the vaccine for emergency use.[15]

See also

References

  1. ^ Clinical trial number NCT04944368 for "Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)" at ClinicalTrials.gov
  2. ^ "Patent Landscape Report COVID-19-related vaccines and therapeutics" (PDF).
  3. ^ ""Spikogen", A Joint Venture Between Vaxine And Cinnagen". Vaxine. Archived from the original on 11 July 2021. Retrieved 28 July 2021.
  4. ^ a b c "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 25 μg with dosing interval of 21 days)". irct.ir. 2 August 2021. IRCT20150303021315N24. Archived from the original on 3 August 2021. Retrieved 3 August 2021.
  5. ^ Griffin P (23 June 2021). "What is COVAX-19? Australia's most advanced COVID vaccine candidate". medicine.uq.edu.au. Retrieved 5 August 2021.
  6. ^ Clinical trial number NCT04453852 for "Monovalent Recombinant COVID19 Vaccine (COVAX19)" at ClinicalTrials.gov
  7. ^ a b Griffin, Paul (23 June 2021). "What is COVAX-19, the most advanced of Australia's remaining local COVID vaccine candidates?". The Conversation. Retrieved 15 November 2021.
  8. ^ ""SpikoGen", a joint venture between Vaxine and CinnaGen – Vaxine". Archived from the original on 11 July 2021. Retrieved 28 July 2021.
  9. ^ "CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine's COVID-19 Vaccine Technology – Vaxine". Archived from the original on 15 November 2021. Retrieved 15 November 2021.
  10. ^ 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.
  11. ^ "چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen" (in Persian). 26 April 2020. Archived from the original on 9 July 2021. Retrieved 7 September 2021.
  12. ^ "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 25 μg with dosing interval of 21 days)". en.irct.ir. Retrieved 7 September 2021.
  13. ^ 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.
  14. ^ 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.
  15. ^ "Iran issues emergency permit for new local Covid-19 vaccine". Mehr News Agency. 6 October 2021. Retrieved 11 October 2021.
Scholia has a profile for COVAX-19 (Q107864269).


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