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COVAX-19

From Wikipedia, the free encyclopedia
Vaccine candidate against COVID-19

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Pharmaceutical compound
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 ofa 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.
virus iconCOVID-19 portal

COVAX-19 (orSpikoGen) is a recombinant protein-basedCOVID-19 vaccine developed bySouth Australian-based biotech company Vaxine, in collaboration with CinnaGen, a private company with operations inWest Asia. It is underclinical trial in collaboration with theIranian companyCinnaGen.[3][4][5]

Medical uses

[edit]

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

Pharmacology

[edit]

COVAX-19 is a recombinantprotein subunit.[6]

History

[edit]

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

[edit]
Clinical trials of COVAX-19 (SpikoGen)
PhaseRegistration numberStartNumber of participantsAge of participantsLocationRef
TotalVaccinePlacebo
INCT0445385230 June 202040301018–65 yearsAdelaide, Australia[10][11]
IIIRCT20150303021315N23Archived 11 July 2021 at theWayback Machine30 May 202140030010018+ yearsTehran, Iran[12]
NCT04944368[13]
IIIIRCT20150303021315N247 August 202116,87612,6574,21918–50 yearsTehran, Iran[4]
NCT05005559[14]

Authorisations

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

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

See also

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References

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  1. ^Clinical trial numberNCT04944368 for "Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)" atClinicalTrials.gov
  2. ^"Patent Landscape Report COVID-19-related vaccines and therapeutics"(PDF).
  3. ^""Spikogen", A Joint Venture Between Vaxine And Cinnagen". Vaxine. Archived fromthe original on 11 July 2021. Retrieved28 July 2021.
  4. ^abc"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. Retrieved3 August 2021.
  5. ^Griffin P (23 June 2021)."What is COVAX-19? Australia's most advanced COVID vaccine candidate".medicine.uq.edu.au. Retrieved5 August 2021.
  6. ^Clinical trial numberNCT04453852 for "Monovalent Recombinant COVID19 Vaccine (COVAX19)" atClinicalTrials.gov
  7. ^abGriffin, Paul (23 June 2021)."What is COVAX-19, the most advanced of Australia's remaining local COVID vaccine candidates?".The Conversation. Retrieved15 November 2021.
  8. ^""SpikoGen", a joint venture between Vaxine and CinnaGen – Vaxine". Archived fromthe original on 11 July 2021. Retrieved28 July 2021.
  9. ^"CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine's COVID-19 Vaccine Technology – Vaxine". Archived fromthe original on 15 November 2021. Retrieved15 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 fromthe original on 9 July 2021. Retrieved7 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. Archived fromthe original on 11 July 2021. Retrieved7 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. Retrieved11 October 2021.
Scholia has a profile forCOVAX-19(Q107864269).
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