tetano
Editor, Senior Moderator
Hum Vaccin Immunother
. 2024 Dec 31;20(1):2363016.
doi: 10.1080/21645515.2024.2363016. Epub 2024 Jun 5. Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine
Nikolai Petrovsky[SUP] 1 2 [/SUP]
Affiliations
Recombinant protein vaccines represent a well-established, reliable and safe approach for pandemic vaccination. SpikoGen® is a recombinant spike protein trimer manufactured in insect cells and formulated with Advax-CpG55.2 adjuvant. In murine, hamster, ferret and non-human primate studies, SpikoGen® consistently provided protection against a range of SARS-CoV-2 variants. A pivotal Phase 3 placebo-controlled efficacy trial involving 16,876 participants confirmed the ability of SpikoGen® to prevent infection and severe disease caused by the virulent Delta strain. SpikoGen® subsequently received a marketing authorization from the Iranian FDA in early October 2021 for prevention of COVID-19 in adults. Following a successful pediatric study, its approval was extended to children 5 years and older. Eight million doses of SpikoGen® have been delivered, and a next-generation booster version is currently in development. This highlights the benefits of adjuvanted protein-based approaches which should not overlook when vaccine platforms are being selected for future pandemics.
Keywords: COVID-19; SARS-CoV-2; Vaccine; adjuvant; coronavirus; pandemic
. 2024 Dec 31;20(1):2363016.
doi: 10.1080/21645515.2024.2363016. Epub 2024 Jun 5. Clinical development of SpikoGen®, an Advax-CpG55.2 adjuvanted recombinant spike protein vaccine
Nikolai Petrovsky[SUP] 1 2 [/SUP]
Affiliations
- PMID: 38839044
- DOI: 10.1080/21645515.2024.2363016
Recombinant protein vaccines represent a well-established, reliable and safe approach for pandemic vaccination. SpikoGen® is a recombinant spike protein trimer manufactured in insect cells and formulated with Advax-CpG55.2 adjuvant. In murine, hamster, ferret and non-human primate studies, SpikoGen® consistently provided protection against a range of SARS-CoV-2 variants. A pivotal Phase 3 placebo-controlled efficacy trial involving 16,876 participants confirmed the ability of SpikoGen® to prevent infection and severe disease caused by the virulent Delta strain. SpikoGen® subsequently received a marketing authorization from the Iranian FDA in early October 2021 for prevention of COVID-19 in adults. Following a successful pediatric study, its approval was extended to children 5 years and older. Eight million doses of SpikoGen® have been delivered, and a next-generation booster version is currently in development. This highlights the benefits of adjuvanted protein-based approaches which should not overlook when vaccine platforms are being selected for future pandemics.
Keywords: COVID-19; SARS-CoV-2; Vaccine; adjuvant; coronavirus; pandemic