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SpikoGen vaccine
SpikoGen is a recombinant protein vaccine designed to stimulate immune responses against SARS-CoV-2 spike protein.
SpikoGen is a recombinant protein vaccine designed to stimulate immune responses against SARS-CoV-2 spike protein. Used for COVID-19 prevention (SARS-CoV-2 infection).
At a glance
| Generic name | SpikoGen vaccine |
|---|---|
| Also known as | Covax-19 |
| Sponsor | Vaxine Pty Ltd |
| Drug class | Recombinant protein vaccine |
| Target | SARS-CoV-2 spike protein |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
SpikoGen uses recombinant spike protein technology to train the immune system to recognize and respond to SARS-CoV-2. The vaccine aims to generate both antibody and T-cell mediated immunity against the viral spike protein, which is the primary target for neutralizing antibodies. This approach differs from mRNA and viral vector vaccines by using a directly manufactured protein antigen.
Approved indications
- COVID-19 prevention (SARS-CoV-2 infection)
Common side effects
- Injection site pain or swelling
- Fatigue
- Headache
- Myalgia
- Fever
Key clinical trials
- Covid-19 and Influenza Oral Vaccine Study (PHASE1)
- A Phase 3b/4 Randomised Trial of 3 Doses of Protein-based Covid-19 Vaccine (SpikoGen) (PHASE3)
- Booster Study of SpikoGen COVID-19 Vaccine (PHASE3)
- Australian Phase 2b Study to Assess Effect of Dose Interval on Spikogen Covid-19 Vaccine (PHASE2, PHASE3)
- Immunogenicity and Safety of a Booster Dose of the SpikoGen Vaccine in Kidney Transplant Recipients After Two Doses of Sinopharm Vaccine (NA)
- Immunogenicity and Safety of the SpikoGen COVID-19 Vaccine in Children Aged 5 to <12 Years and 12 to <18 Years Compared With Adults Aged 18 to 40 Years (PHASE3)
- Immunogenicity and Safety of a Booster Dose of the SpikoGen COVID-19 Vaccine (PHASE3)
- Phase III Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen) (PHASE3)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |