COVAX-19

COVAX-19
Vaccine description
Target	SARS-CoV-2
Vaccine type	Protein subunit
Clinical data
Trade names	Spikogen
Routes of; administration	Intramuscular
Legal status
Legal status	Full and Emergency Authorizations: List of COVAX-19 COVID-19 vaccine 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]

Medical uses

It requires two doses given by intramuscular injection 21 days apart.^[3]

Pharmacology

COVAX-19 is a recombinant protein subunit.^[5]

History

In a new cooperation agreement, Phases 2 and 3 clinical trials of COVAX-19 will be initiated in Iran. If these studies are successful, this Australian vaccine will be produced under the brand name SpikoGen by CinnaGen Company and will be rolled out in Iran^[6]

Under a deal negotiated in May 2021, Immuron agreed to pay about $100 million in cash and scrip for the privately owned biotechnology company Vaxine, which was founded by Nikolai Petrovsky.^[7] A director of Immuron, Peter Anastasiou, who resigned from the board, says the deal to buy Vaxine had a set termination date that could not be met because the transaction was caught up in the ASX listings process. A response from Immuron on 3 September to an ASX letter asking more questions about Vaxine contained new information and inconsistencies, including the existence of Covaxia Ltd, an entity owned by Petrovsky and Sharen Pringle, a shareholder of Vaxine. The new information included the existence of an agreement between Covaxia and Iranian pharmaceutical company CinnaGen Research to permit the supply of Vaxine’s Advax adjuvant to CinnaGen and to permit a technology transfer to the CinnaGen facilities in Iran. Also, Immuron revealed that the CinnaGen COVID-19 vaccine known as SpikoGen is a biosimilar (or replica) of Vaxine’s own COVAX-19 protein-based COVID-19 vaccine, and is not Vaxine’s own vaccine, information that had not been previously disclosed by Vaxine. The deal to buy Vaxine was first negotiated in May, before the target company started a phase two clinical trial with 400 people in Iran in partnership with CinnaGen Corp.

Clinical trials

Clinical trials of COVAX-19 (SpikoGen)
Phase	Registration number	Start	Number of participants			Age of participants	Location	Ref
Phase	Registration number	Start	Total	Vaccine	Placebo	Age of participants	Location	Ref
I	NCT04453852	30 June 2020	40	30	10	18-65 years	Adelaide, Australia	^[8]^[9]
II	IRCT20150303021315N23	30 May 2021	400	300	100	18+ years	Tehran, Iran	^[10]
II	NCT04944368	30 May 2021	400	300	100	18+ years	Tehran, Iran	^[11]
III	IRCT20150303021315N24	7 August 2021	16,876	12,657	4,219	18-50 years	Tehran, Iran	^[3]
III	NCT05005559	7 August 2021	16,876	12,657	4,219	18-50 years	Tehran, Iran	^[12]

Authorizations

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

References

^ Clinical trial number NCT04944368 for "Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)" at ClinicalTrials.gov
^ ""Spikogen", A Joint Venture Between Vaxine And Cinnagen". Vaxine.
^ ^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. Retrieved 3 August 2021.{{cite web}}: CS1 maint: url-status (link)
^ Griffin P (23 June 2021). "What is COVAX-19? Australia's most advanced COVID vaccine candidate". medicine.uq.edu.au. Retrieved 5 August 2021.
^ Clinical trial number NCT04453852 for "Monovalent Recombinant COVID19 Vaccine (COVAX19)" at ClinicalTrials.gov
^ ""SpikoGen®", a joint venture between Vaxine and CinnaGen – Vaxine".
^ https://www.afr.com/chanticleer/iran-link-kills-covid-19-vaccine-takeover-20210927-p58v1k. {{cite web}}: Missing or empty |title= (help)
^ 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)
^ "چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen" (in Persian). 26 April 2020. Retrieved 7 September 2021.
^ "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.
^ 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)
^ 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)
^ "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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[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.

[:0-3] "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.{{cite web}}: CS1 maint: url-status (link)

[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.

[NCT04453852-5] Clinical trial number NCT04453852 for "Monovalent Recombinant COVID19 Vaccine (COVAX19)" at ClinicalTrials.gov

[6] ""SpikoGen®", a joint venture between Vaxine and CinnaGen – Vaxine".

[7] ttps://www.afr.com/chanticleer/iran-link-kills-covid-19-vaccine-takeover-20210927-p58v1k. {{cite web}}: Missing or empty |title= (help)

[8] 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)

[9] "چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen" (in Persian). 26 April 2020. Retrieved 7 September 2021.

[10] "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.

[11] 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)

[12] 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)

[13] "Iran issues emergency permit for new local Covid-19 vaccine". Mehr News Agency. 6 October 2021. Retrieved 11 October 2021.

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