COVAX-19

Last updated

COVAX-19
Vaccine description
Target SARS-CoV-2
Vaccine type Protein subunit
Clinical data
Trade names Spikogen [1]
Routes of
administration
Intramuscular
Legal status
Legal status
  • Full and emergency authorizations
Full list of COVAX-19 authorizations

COVAX-19 (or SpikoGen) 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]

Contents

Medical uses

It requires two doses given by intramuscular injection 21 days apart. [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 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. [6]

Phases 2 and 3 clinical trials of COVAX-19 are being conducted in Iran under a co-operation agreement. [7] [ dead link ] 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, the vaccine will be produced under the name COVAX-19 in Australia and SpikoGen produced by Cinnagen in Iran. [6] [8]

Clinical trials

Clinical trials of COVAX-19 (SpikoGen)
PhaseRegistration numberStartNumber of participantsAge of participantsLocationRef
TotalVaccinePlacebo
I NCT04453852 30 June 202040301018-65 years Adelaide, Australia [9] [10]
II IRCT20150303021315N23 30 May 202140030010018+ years Tehran, Iran [11]
NCT04944368 [12]
III IRCT20150303021315N24 7 August 202116,87612,6574,21918-50 years Tehran, Iran [3]
NCT05005559 [13]

Authorizations

On 6 October 2021, Iran has approved the vaccine for emergency use. [14]

Related Research Articles

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References

  1. Clinical trial number NCT04944368 for "Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)" at ClinicalTrials.gov
  2. ""Spikogen", A Joint Venture Between Vaxine And Cinnagen". Vaxine.
  3. 1 2 3 "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)". irct.ir. 2 August 2021. IRCT20150303021315N24. Retrieved 3 August 2021.
  4. Griffin P (23 June 2021). "What is COVAX-19? Australia's most advanced COVID vaccine candidate". medicine.uq.edu.au. Retrieved 5 August 2021.
  5. Clinical trial number NCT04453852 for "Monovalent Recombinant COVID19 Vaccine (COVAX19)" at ClinicalTrials.gov
  6. 1 2 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.
  7. ""SpikoGen®", a joint venture between Vaxine and CinnaGen – Vaxine".
  8. "CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine's COVID-19 Vaccine Technology – Vaxine" . Retrieved 15 November 2021.
  9. 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.Cite journal requires |journal= (help)
  10. "چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen" (in Persian). 26 April 2020. Retrieved 7 September 2021.
  11. "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)". en.irct.ir. Retrieved 7 September 2021.
  12. 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.Cite journal requires |journal= (help)
  13. 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.Cite journal requires |journal= (help)
  14. "Iran issues emergency permit for new local Covid-19 vaccine". Mehr News Agency. 6 October 2021. Retrieved 11 October 2021.