Created at Source Raw Value Validated value
Dec. 10, 2021, 2 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "The investigational vaccine; IVX-411; is a computationally-designed recombinant protein virus-like particle (VLP) vaccine under development for the prevention of COVID-19 caused by SARS-CoV-2.\u2018IVX-411 study vaccine\u2019 refers to either the aqueous formulation IVX-411a or the adjuvanted formulation IVX-411d. The volume of vaccine formulation to be administered via intramuscular injection is 0.5 mL.It is a first-in-human (FIH) study to evaluate the safety and immunogenicity of IVX-411 in 84 healthy SARS-CoV-2-seronegative adults 18 to 69 years of age.The participants will be randomly allocated to one of six IVX-411 formulations (low; medium or high doses with or without MF59) or to the Placebo arm. IVX-411 will be administered intramuscularly as two doses given 28 days apart.The inclusion of MF59 adjuvant in the vaccine is expected to enhance the immune response and increase the duration of the immune response; which is important in prolonged SARS-CoV-2 circulation and/or ongoing outbreaks.The dose levels of IVX-411 with or without MF59 are 5; 25 or 125 \u00b5g.Adherence to intervention is not applicable since this is not self-administered and will be administered intramuscularly by trial site personnel as two doses given 28 days apart.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "", "treatment_id": 695, "treatment_name": "Ivx-411", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]

June 17, 2021, 12:45 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "The investigational vaccine; IVX-411; is a computationally-designed recombinant protein virus-like particle (VLP) vaccine under development for the prevention of COVID-19 caused by SARS-CoV-2.\u2018IVX-411 study vaccine\u2019 refers to either the aqueous formulation IVX-411a or the adjuvanted formulation IVX-411d. The volume of vaccine formulation to be administered via intramuscular injection is 0.5 mL.It is a first-in-human (FIH) study to evaluate the safety and immunogenicity of IVX-411 in 84 healthy SARS-CoV-2-seronegative adults 18 to 69 years of age.The participants will be randomly allocated to one of six IVX-411 formulations (low; medium or high doses with or without MF59) or to the Placebo arm. IVX-411 will be administered intramuscularly as two doses given 28 days apart.The inclusion of MF59 adjuvant in the vaccine is expected to enhance the immune response and increase the duration of the immune response; which is important in prolonged SARS-CoV-2 circulation and/or ongoing outbreaks.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]