.mw-parser-output .hidden-begin{box-sizing:border-box;width:100%;padding:5px;border:none;font-size:95%}.mw-parser-output .hidden-title{font-weight:bold;line-height:1.6;text-align:left}.mw-parser-output .hidden-content{text-align:left}You can help expand this article with text translated from the corresponding article in Persian. (January 2022) Click [show] for important translation instructions. View a machine-translated version of the Persian article. Machine translation, like DeepL or Google Translate, is a useful starting point for translations, but translators must revise errors as necessary and confirm that the translation is accurate, rather than simply copy-pasting machine-translated text into the English Wikipedia. Consider adding a topic to this template: there are already 310 articles in the main category, and specifying|topic= will aid in categorization. Do not translate text that appears unreliable or low-quality. If possible, verify the text with references provided in the foreign-language article. You must provide copyright attribution in the edit summary accompanying your translation by providing an interlanguage link to the source of your translation. A model attribution edit summary is Content in this edit is translated from the existing Persian Wikipedia article at [[:fa:اسپایکوژن]]; see its history for attribution. You should also add the template ((Translated|fa|اسپایکوژن)) to the talk page. For more guidance, see Wikipedia:Translation.
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
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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.[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

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 [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

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

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

See also

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. Archived from the original on 11 July 2021. Retrieved 28 July 2021.
  3. ^ 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 25µg with dosing interval of 21 days)". irct.ir. 2 August 2021. IRCT20150303021315N24. Archived from the original on 3 August 2021. 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. ^ 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.
  7. ^ ""SpikoGen®", a joint venture between Vaxine and CinnaGen – Vaxine". Archived from the original on 11 July 2021. Retrieved 28 July 2021.
  8. ^ "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.
  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)): Cite journal requires |journal= (help)
  10. ^ "چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen" (in Persian). 26 April 2020. Archived from the original on 9 July 2021. 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)): 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)): 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.
Scholia has a profile for COVAX-19 (Q107864269).


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