COVAX-19

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| type = vaccine

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| target = SARS-CoV-2

| vaccine_type = protein

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| tradename = Spikogen{{ClinicalTrialsGov|NCT04944368|Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)}}

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| legal_status = Full and emergency authorisations

Full list of COVAX-19 authorisations

| routes_of_administration = Intramuscular

| CAS_number = 2543231-22-5

| CAS_number_Ref = {{cite web|url=https://www.wipo.int/edocs/pubdocs/en/wipo-pub-1075-en-covid-19-related-vaccines-and-therapeutics.pdf|title=Patent Landscape Report COVID-19-related vaccines and therapeutics}}

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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 West Asia. It is under clinical trial in collaboration with the Iranian company CinnaGen.{{cite web |title="Spikogen", A Joint Venture Between Vaxine And Cinnagen |url=https://vaxine.net/spikogen-a-joint-venture-between-vaxine-and-cinnagen/ |publisher=Vaxine |access-date=28 July 2021 |archive-date=11 July 2021 |archive-url=https://web.archive.org/web/20210711080947/https://vaxine.net/spikogen-a-joint-venture-between-vaxine-and-cinnagen/ |url-status=dead }}{{cite web | title = 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) |url=https://www.irct.ir/trial/57559 |website=irct.ir |id=IRCT20150303021315N24 |date=2 August 2021 |access-date=3 August 2021 |url-status=live |archive-url=https://web.archive.org/web/20210803151416/https://www.irct.ir/trial/57559 |archive-date=3 August 2021 }}{{cite web | vauthors = Griffin P |title=What is COVAX-19? Australia's most advanced COVID vaccine candidate |url=https://medicine.uq.edu.au/article/2021/06/what-covax-19-australias-most-advanced-covid-vaccine%C2%A0candidate |website=medicine.uq.edu.au |access-date=5 August 2021 |language=en |date=23 June 2021}}

Medical uses

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

Pharmacology

COVAX-19 is a recombinant protein subunit.{{ClinicalTrialsGov|NCT04453852|Monovalent Recombinant COVID19 Vaccine (COVAX19)}}

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.{{cite web |last1=Griffin |first1=Paul |title=What is COVAX-19, the most advanced of Australia's remaining local COVID vaccine candidates? |url=https://theconversation.com/what-is-covax-19-the-most-advanced-of-australias-remaining-local-covid-vaccine-candidates-162347 |website=The Conversation |access-date=15 November 2021 |language=en |date=23 June 2021}}

Phases 2 and 3 clinical trials of COVAX-19 are being conducted in Iran under a co-operation agreement.{{Cite web|url=https://vaxine.net/spikogen-a-joint-venture-between-vaxine-and-cinnagen/|title="SpikoGen", a joint venture between Vaxine and CinnaGen – Vaxine|access-date=28 July 2021|archive-date=11 July 2021|archive-url=https://web.archive.org/web/20210711080947/https://vaxine.net/spikogen-a-joint-venture-between-vaxine-and-cinnagen/|url-status=dead}} 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.{{cite web |title=CinnaGen Initiates a Phase 3 Clinical Trial of Vaxine's COVID-19 Vaccine Technology – Vaxine |url=https://vaxine.net/vaxine-and-cinnagen-initiated-a-phase-3-clinical-trial-for-their-covid-19-vaccine-candidate/ |access-date=15 November 2021 |archive-date=15 November 2021 |archive-url=https://web.archive.org/web/20211115131243/https://vaxine.net/vaxine-and-cinnagen-initiated-a-phase-3-clinical-trial-for-their-covid-19-vaccine-candidate/ |url-status=dead }}

= Clinical trials =

class="wikitable" \|+Clinical trials of COVAX-19 (SpikoGen) ! rowspan="2" \|Phase ! rowspan="2" \|Registration number ! rowspan="2" \|Start ! colspan="3" \|Number of participants ! rowspan="2" \|Age of participants ! rowspan="2" \|Location ! rowspan="2" \|Ref
Total !Vaccine !Placebo
I \|[https://clinicaltrials.gov/ct2/show/NCT04453852 NCT04453852] \|30 June 2020 \|40 \|30 \|10 \|18–65 years \|Adelaide, Australia \|{{Cite web\|last=Vaxine Pty Ltd\|date=5 May 2021\|others=Central Adelaide Local Health Network Incorporated\|title=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\|url=https://clinicaltrials.gov/ct2/show/NCT04453852}}{{Cite web\|date=26 April 2020\|title=چرا واکسن اسپایکوژن؟ {{!}} واکسن کرونا اسپایکوژن {{!}} spikogen\|url=https://spikogen.com/why-spikogen/\|access-date=7 September 2021\|language=fa-IR\|archive-date=9 July 2021\|archive-url=https://web.archive.org/web/20210709181815/https://spikogen.com/why-spikogen/\|url-status=dead}}
rowspan="2" \|II \|[https://en.irct.ir/trial/56287 IRCT20150303021315N23] \| rowspan="2" \|30 May 2021 \| rowspan="2" \|400 \| rowspan="2" \|300 \| rowspan="2" \|100 \| rowspan="2" \|18+ years \| rowspan="2" \|Tehran, Iran \|{{Cite web\|title=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)\|url=https://en.irct.ir/trial/56287\|access-date=7 September 2021\|website=en.irct.ir}}
[https://clinicaltrials.gov/ct2/show/NCT04944368 NCT04944368] \|{{Cite web\|last=Cinnagen\|date=14 August 2021\|others=Vaxine Pty Ltd\|title=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)\|url=https://clinicaltrials.gov/ct2/show/NCT04944368}}
rowspan="2" \|III \|[https://www.irct.ir/trial/57559 IRCT20150303021315N24] \| rowspan="2" \|7 August 2021 \| rowspan="2" \|16,876 \| rowspan="2" \|12,657 \| rowspan="2" \|4,219 \| rowspan="2" \|18–50 years \| rowspan="2" \|Tehran, Iran \|
[https://clinicaltrials.gov/ct2/show/NCT05005559 NCT05005559] \|{{Cite web\|last=Cinnagen\|date=11 August 2021\|others=Vaxine Pty Ltd\|title=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)\|url=https://clinicaltrials.gov/ct2/show/NCT05005559}}

class="wikitable"

|+Clinical trials of COVAX-19 (SpikoGen)

! rowspan="2" |Phase

! rowspan="2" |Registration number

! rowspan="2" |Start

! colspan="3" |Number of participants

! rowspan="2" |Age of participants

! rowspan="2" |Location

! rowspan="2" |Ref

Total

!Vaccine

!Placebo

|[https://clinicaltrials.gov/ct2/show/NCT04453852 NCT04453852]

|30 June 2020

|40

|30

|10

|18–65 years

|Adelaide, Australia

|{{Cite web|last=Vaxine Pty Ltd|date=5 May 2021|others=Central Adelaide Local Health Network Incorporated|title=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|url=https://clinicaltrials.gov/ct2/show/NCT04453852}}{{Cite web|date=26 April 2020|title=چرا واکسن اسپایکوژن؟ {{!}} واکسن کرونا اسپایکوژن {{!}} spikogen|url=https://spikogen.com/why-spikogen/|access-date=7 September 2021|language=fa-IR|archive-date=9 July 2021|archive-url=https://web.archive.org/web/20210709181815/https://spikogen.com/why-spikogen/|url-status=dead}}

rowspan="2" |II

|[https://en.irct.ir/trial/56287 IRCT20150303021315N23]

| rowspan="2" |30 May 2021

| rowspan="2" |400

| rowspan="2" |300

| rowspan="2" |100

| rowspan="2" |18+ years

| rowspan="2" |Tehran, Iran

|{{Cite web|title=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)|url=https://en.irct.ir/trial/56287|access-date=7 September 2021|website=en.irct.ir}}

[https://clinicaltrials.gov/ct2/show/NCT04944368 NCT04944368]

|{{Cite web|last=Cinnagen|date=14 August 2021|others=Vaxine Pty Ltd|title=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)|url=https://clinicaltrials.gov/ct2/show/NCT04944368}}

rowspan="2" |III

|[https://www.irct.ir/trial/57559 IRCT20150303021315N24]

| rowspan="2" |7 August 2021

| rowspan="2" |16,876

| rowspan="2" |12,657

| rowspan="2" |4,219

| rowspan="2" |18–50 years

| rowspan="2" |Tehran, Iran

[https://clinicaltrials.gov/ct2/show/NCT05005559 NCT05005559]

|{{Cite web|last=Cinnagen|date=11 August 2021|others=Vaxine Pty Ltd|title=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)|url=https://clinicaltrials.gov/ct2/show/NCT05005559}}

=Authorisations=

On 6 October 2021, Iran approved the vaccine for emergency use.{{cite news |title=Iran issues emergency permit for new local Covid-19 vaccine |url=https://en.mehrnews.com/news/179432/Iran-issues-emergency-permit-for-new-local-Covid-19-vaccine |access-date=11 October 2021 |publisher=Mehr News Agency |date= 6 October 2021}}

References

Category:Australian COVID-19 vaccines

Category:Iranian COVID-19 vaccines

Category:Protein subunit vaccines