COVAX-19 explained

Type:vaccine
Target:SARS-CoV-2
Vaccine Type:protein
Tradename:Spikogen
Legal Status:Full and emergency authorisations

Full list of COVAX-19 authorisations

Routes Of Administration:Intramuscular
Cas Number:2543231-22-5
Cas Number Ref:[1]

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.[2] [3] [4]

Medical uses

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

Pharmacology

COVAX-19 is a recombinant protein subunit.

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! rowspan="2"
Registration numberStartNumber of participantsAge of participantsLocationRef
TotalVaccinePlacebo
INCT0445385230 June 202040301018–65 yearsAdelaide, Australia[8] [9]
IIIRCT20150303021315N2330 May 202140030010018+ yearsTehran, Iran[10]
NCT04944368[11]
IIIIRCT20150303021315N247 August 202116,87612,6574,21918–50 yearsTehran, Iran
NCT05005559[12]

Authorisations

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

See also

Notes and References

  1. Web site: Patent Landscape Report COVID-19-related vaccines and therapeutics.
  2. Web site: "Spikogen", A Joint Venture Between Vaxine And Cinnagen . Vaxine . 28 July 2021 . 11 July 2021 . https://web.archive.org/web/20210711080947/https://vaxine.net/spikogen-a-joint-venture-between-vaxine-and-cinnagen/ . dead .
  3. Web site: 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 . IRCT20150303021315N24 . 2 August 2021 . 3 August 2021 . live . https://web.archive.org/web/20210803151416/https://www.irct.ir/trial/57559 . 3 August 2021 .
  4. Web site: Griffin P . What is COVAX-19? Australia's most advanced COVID vaccine candidate . medicine.uq.edu.au . 5 August 2021 . en . 23 June 2021.
  5. Web site: Griffin . Paul . What is COVAX-19, the most advanced of Australia's remaining local COVID vaccine candidates? . The Conversation . 15 November 2021 . en . 23 June 2021.
  6. Web site: "SpikoGen", a joint venture between Vaxine and CinnaGen – Vaxine. 28 July 2021. 11 July 2021. https://web.archive.org/web/20210711080947/https://vaxine.net/spikogen-a-joint-venture-between-vaxine-and-cinnagen/. dead.
  7. Web site: CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine's COVID-19 Vaccine Technology – Vaxine . 15 November 2021 . 15 November 2021 . https://web.archive.org/web/20211115131243/https://vaxine.net/vaxine-and-cinnagen-initiated-a-phase-3-clinical-trial-for-their-covid-19-vaccine-candidate/ . dead .
  8. Web site: Vaxine Pty Ltd. 5 May 2021. Central Adelaide Local Health Network Incorporated. 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.
  9. Web site: 26 April 2020. چرا واکسن اسپایکوژن؟ واکسن کرونا اسپایکوژن spikogen. 7 September 2021. fa-IR. 9 July 2021. https://web.archive.org/web/20210709181815/https://spikogen.com/why-spikogen/. dead.
  10. Web site: 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). 7 September 2021. en.irct.ir.
  11. Web site: Cinnagen. 14 August 2021. Vaxine Pty Ltd. 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).
  12. Web site: Cinnagen. 11 August 2021. Vaxine Pty Ltd. 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).
  13. News: Iran issues emergency permit for new local Covid-19 vaccine . 11 October 2021 . . 6 October 2021.

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