COVAX-19

Last updated

COVAX-19
Vaccine description
Target SARS-CoV-2
Vaccine type Protein subunit
Clinical data
Trade names Spikogen [1]
Routes of
administration 		Intramuscular
Legal status
Legal status
  • Full and emergency authorisations
Full list of COVAX-19 authorisations

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]

Contents

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)
PhaseRegistration numberStartNumber of participantsAge of participantsLocationRef
TotalVaccinePlacebo
I NCT04453852 30 June 202040301018–65 years Adelaide, Australia [9] [10]
II IRCT20150303021315N23 30 May 202140030010018+ years Tehran, Iran [11]
NCT04944368 [12]
III IRCT20150303021315N24 7 August 202116,87612,6574,21918–50 years Tehran, Iran [3]
NCT05005559 [13]

Authorisations

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

See also

Related Research Articles

<span class="mw-page-title-main">Cinnagen</span> Iran-based biotechnology company

CinnaGen is an Iran based biotechnology company that was founded in 1994 by four scientists. As of 2016, it manufactured biosimilar drugs, laboratory diagnostic reagents for in vitro use, and recombinant proteins, and exported to other countries in the Middle East and to countries in the Commonwealth of Independent States.

<span class="mw-page-title-main">Novavax</span> American biotechnology company

Novavax, Inc. is an American biotechnology company based in Gaithersburg, Maryland, that develops vaccines to counter serious infectious diseases. Prior to 2020, company scientists developed experimental vaccines for influenza and respiratory syncytial virus (RSV), as well as Ebola and other emerging infectious diseases. During 2020, the company redirected its efforts to focus on development and approval of its NVX-CoV2373 vaccine for COVID-19.

<span class="mw-page-title-main">Novavax COVID-19 vaccine</span> Vaccine against COVID-19

The Novavax COVID-19 vaccine, sold under the brand names Nuvaxovid and Covovax, among others, is a subunit COVID-19 vaccine developed by Novavax and the Coalition for Epidemic Preparedness Innovations (CEPI).

<span class="mw-page-title-main">ZF2001</span> Vaccine against COVID-19

ZF2001, trade-named Zifivax or ZF-UZ-VAC-2001, is an adjuvanted protein subunit COVID-19 vaccine developed by Anhui Zhifei Longcom in collaboration with the Institute of Microbiology at the Chinese Academy of Sciences. The vaccine candidate is in Phase III trials with 29,000 participants in China, Ecuador, Malaysia, Pakistan, and Uzbekistan.

<span class="mw-page-title-main">CoVLP</span> COVID-19 vaccine candidate produced in a plant

CoVLP was a COVID-19 vaccine developed by Medicago in Canada and GlaxoSmithKline (GSK). The product and Medicago, Inc. were owned by Mitsubishi who terminated the company and program in February 2023 due to high international market competition for COVID-19 vaccines.

<span class="mw-page-title-main">Soberana 02</span> Vaccine against COVID-19

Soberana 02 or Soberana 2, technical name FINLAY-FR-2, is a COVID-19 vaccine produced by the Finlay Institute, a Cuban epidemiological research institute. The vaccine is known as PastoCovac in Iran, where it has been developed in collaboration with the Pasteur Institute of Iran.

<span class="mw-page-title-main">COVIran Barekat</span> COVIran Barakat vaccine against COVID-19

COVIran Barekat is a COVID-19 vaccine developed in Iran by Shifa Pharmed Industrial Group, a subsidiary of the Barkat Pharmaceutical Group. It is an inactivated virus-based vaccine. Iranian authorities have authorized its emergency use. This makes it the first locally developed COVID-19 vaccine to be approved for emergency use in the Middle East.

<span class="mw-page-title-main">SCB-2019</span> Vaccine candidate against COVID-19

SCB-2019 is a protein subunit COVID-19 vaccine developed by Clover Biopharmaceuticals using an adjuvant from Dynavax technologies. Positive results of Phase I trials for the vaccine were published in The Lancet and the vaccine completed enrollment of 29,000 participants in Phase II/III trials in July 2021. In September 2021, SCB-2019 announced Phase III results showing 67% efficacy against all cases of COVID-19 and 79% efficacy against all cases of the Delta variant. Additionally, the vaccine was 84% effective against moderate cases and 100% effective against hospitalization.

<span class="mw-page-title-main">Sanofi–GSK COVID-19 vaccine</span> Vaccine candidate against COVID-19

The Sanofi–GSK COVID-19 vaccine sold under the brand name VidPrevtyn Beta, is a COVID-19 vaccine developed by Sanofi Pasteur and GSK.

<span class="mw-page-title-main">Nanocovax</span> Vaccine candidate against COVID-19

Nanocovax is a Vietnamese COVID-19 vaccine candidate developed by Nanogen Pharmaceutical Biotechnology JSC. It is a subunit vaccine.

<span class="mw-page-title-main">MVC COVID-19 vaccine</span> Vaccine against COVID-19

The MVC COVID-19 vaccine, designated MVC-COV1901 and also known as the Medigen COVID-19 vaccine, is a protein subunit COVID-19 vaccine developed by Medigen Vaccine Biologics Corporation in Taiwan, American company Dynavax Technologies, and the U.S. National Institutes of Health.

<span class="mw-page-title-main">Walvax COVID-19 vaccine</span> Vaccine candidate against COVID-19

AWcorna, originally termed ARCoV and also known as the Walvax COVID-19 vaccine, is an mRNA COVID-19 vaccine developed by Walvax Biotechnology, Suzhou Abogen Biosciences, and the PLA Academy of Military Science. In contrast to other mRNA COVID vaccines, such as those by Pfizer-BioNtech and Moderna, this vaccine primarily targets the Sars-CoV-2 receptor-binding domain of the spike protein, rather than the entire spike protein. It is approved for Phase III trials in China, Mexico, Indonesia, and Nepal.

<span class="mw-page-title-main">V-01</span> Vaccine candidate against COVID-19

V-01 is a protein subunit COVID-19 vaccine candidate developed by a subsidiary of Livzon Pharmaceutical Group Inc.

<span class="mw-page-title-main">Razi Cov Pars</span> Vaccine candidate against COVID-19

Razi Cov Pars is a COVID-19 vaccine developed by the Iranian Razi Vaccine and Serum Research Institute Razi Cov Pars is a covid-19 vaccine based on recombinant protein, which is being produced by Razi Vaccine and Serum Research Institute, Iran. This vaccine is the first injectable-intranasal recombinant protein corona vaccine.It's the second Iranian COVID-19 vaccine reaching human trials and is currently in phase III of clinical research during which it's compared to the Sinopharm BIBP vaccine.

<span class="mw-page-title-main">FAKHRAVAC</span> Vaccine against COVID-19

FAKHRAVAC is a COVID-19 vaccine developed in Iran by the Organization of Defensive Innovation and Research, a subsidiary of Iran's Ministry of Defense. It is the third Iranian COVID-19 vaccine reaching clinical trials. It is currently in phase III. It received emergency use authorization in Iran on 9 September 2021.

<span class="mw-page-title-main">COVID-19 vaccine clinical research</span> Clinical research to establish the characteristics of COVID-19 vaccines

COVID-19 vaccine clinical research uses clinical research to establish the characteristics of COVID-19 vaccines. These characteristics include efficacy, effectiveness, and safety. As of November 2022, 40 vaccines are authorized by at least one national regulatory authority for public use:

<span class="mw-page-title-main">Noora (vaccine)</span> Vaccine candidate against COVID-19

Noora is a COVID-19 vaccine candidate developed by Baqiyatallah University of Medical Sciences in collaboration with Plasma Darman Sarv Sepid Co. in Iran.

<span class="mw-page-title-main">Soberana Plus</span> Vaccine

Soberana Plus, technical name FINLAY-FR-1A, is a COVID-19 candidate vaccine produced by the Finlay Institute, a Cuban epidemiological research institute.

<span class="mw-page-title-main">S-268019</span> Vaccine candidate against COVID-19

S-268019-b is a protein subunit COVID-19 vaccine candidate developed by Shionogi.

<span class="mw-page-title-main">LYB001</span> Vaccine candidate against COVID-19

LYB001 is a COVID-19 vaccine candidate developed by Yantai Patronus Biotech Co., Ltd.

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. 1 2 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 25 μg 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. 1 2 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 25 μg 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.


Syringe with Green Fluid.jpg

This article about vaccines or vaccination is a stub. You can help Wikipedia by expanding it.

This page is based on this Wikipedia article
Text is available under the CC BY-SA 4.0 license; additional terms may apply.
Images, videos and audio are available under their respective licenses.