Kovaks-19 (COVAX-19 ili SpikoGen) je rekombinantna vakcina protiv kovida 19 zasnovana na proteinima koju je razvila biotehnološka kompanija Vaxine iz Južne Australije. U toku je kliničko ispitivanje vakcine u saradnji sa iranskom kompanijom CinnaGen.[2][3][4]

Ковакс-19
Klinički podaci
Prodajno imeSpikogen[1]
Način primeneu mišić
Pravni status
Pravni status
  • Potpuna i hitna ovlašćenja

Klinička ispitivanja

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Klinička ispitivanja Kovaks-19 (SpikoGen)
Faza Registracioni broj Početak Broj ispitanika Starost ispitanika Lokacija Izvori
Ukupno Vakcina Placebo
I NCT04453852 30. jun 2020 40 30 10 18–65 godina Adelaide, Australija [5][6]
II IRCT20150303021315N23 Arhivirano na sajtu Wayback Machine (11. jul 2021) 30. maj 2021 400 300 100 18+ godina Teheran, Iran [7]
NCT04944368 [8]
III IRCT20150303021315N24 7. avgust 2021 16,876 12,657 4,219 18–50 godina Teheran, Iran [3]
NCT05005559 [9]

Izvori

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  1. ^ Clinical Trials NCT04944368 Phase II Clinical Trial of CinnaGen COVID-19 Vaccine (SpikoGen)
  2. ^ „"Spikogen", A Joint Venture Between Vaxine And Cinnagen”. Vaxine. Arhivirano iz originala 11. 07. 2021. g. Pristupljeno 24. 01. 2022. 
  3. ^ a b „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. 8. 2021. IRCT20150303021315N24. Pristupljeno 3. 8. 2021. 
  4. ^ Griffin P (23. 6. 2021). „What is COVAX-19? Australia's most advanced COVID vaccine candidate”. medicine.uq.edu.au (na jeziku: engleski). Pristupljeno 5. 8. 2021. 
  5. ^ Vaxine Pty Ltd (5. 5. 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. 
  6. ^ „چرا واکسن اسپایکوژن؟ | واکسن کرونا اسپایکوژن | spikogen” (na jeziku: persijski). 26. 4. 2020. Arhivirano iz originala 09. 07. 2021. g. Pristupljeno 7. 9. 2021. 
  7. ^ „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. Arhivirano iz originala 11. 07. 2021. g. Pristupljeno 7. 9. 2021. 
  8. ^ Cinnagen (14. 8. 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. 
  9. ^ Cinnagen (11. 8. 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. 

Spoljašnje veze

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