Eugene, mRNA COVID-19 Vaccine 'EG-COVID' Booster Shot Approved for Phase 1/2a Clinical Trial in Australia
[Asia Economy Reporter Lee Gwan-joo] IGEN announced on the 21st that it has received approval from the Australian health authorities for the Phase 1 and 2a clinical trial plan to verify the booster shot effect of the mRNA-based COVID-19 vaccine 'EG-COVID.'
The Phase 1 trial will administer 'EG-COVID' as a booster shot to 20 adults who have previously received existing vaccines. The Phase 2a trial will explore the booster shot efficacy in 100 participants, of which 30% will be administered to vaccine-naive individuals.
Through this clinical trial, IGEN plans to evaluate the safety, tolerability, and immunogenicity of EG-COVID as a booster shot, as well as confirm the booster shot antibody formation performance.
EG-COVID is characterized by utilizing a cationic liposome, which was independently developed as an mRNA delivery vehicle. While polyethylene glycol (PEG) included in the lipid nanoparticles (LNP) of existing mRNA vaccines is suspected to be a cause of anaphylaxis, EG-COVID does not contain this component, which is expected to enhance safety. Additionally, it can be produced and stored in a freeze-dried formulation, allowing refrigeration storage at 2~8℃, which is considered an advantage.
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IGEN stated, "By additionally applying for clinical trial plans in South Africa on the 3rd, we are expanding the target regions beyond Australia," and added, "If the clinical plan is approved in South Africa as well, we expect to conduct Phase 1 and 2a trials promptly."
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