Created at Source Raw Value Validated value
Dec. 22, 2021, 4:30 p.m. oms

Assess the safety and tolerability of EDV-plasmid-spike-GC administered intramuscularly as two doses in non-COVID-19 infected volunteers. Safety assessment will involve standard clinical monitoring of the following in hospital medical records:- Dose Limiting Toxicities and Adverse Events- Clinical Laboratory Tests (Full Blood Count; Chemistry; C-Reactive Protein; Coagulation Studies; Creatinine Clearance; Urinalysis; Cytokines)- Vital Signs- Physical Examination- 12-Lead Electrocardiogram[Baseline; Day 1; Day 21; Day 28; 2-Months; 3-Months; and 6-Months.];Composite assessment of immune responses of participants receiving the EDV-plasmid-spike-GC through:Serum Biochemistry and HaematologyC-Reactive ProteinIgG and IgM antibody responsesType I interferon responseType II interferon responseVirus neutralising responseCD8+ T-cell responseActivation and proliferation of macrophages; dendritic cells and iNKT cells[Baseline; Day 1; Day 21; Day 28; 2-Months; 3-Months; and 6-Months.]

Assess the safety and tolerability of EDV-plasmid-spike-GC administered intramuscularly as two doses in non-COVID-19 infected volunteers. Safety assessment will involve standard clinical monitoring of the following in hospital medical records:- Dose Limiting Toxicities and Adverse Events- Clinical Laboratory Tests (Full Blood Count; Chemistry; C-Reactive Protein; Coagulation Studies; Creatinine Clearance; Urinalysis; Cytokines)- Vital Signs- Physical Examination- 12-Lead Electrocardiogram[Baseline; Day 1; Day 21; Day 28; 2-Months; 3-Months; and 6-Months.];Composite assessment of immune responses of participants receiving the EDV-plasmid-spike-GC through:Serum Biochemistry and HaematologyC-Reactive ProteinIgG and IgM antibody responsesType I interferon responseType II interferon responseVirus neutralising responseCD8+ T-cell responseActivation and proliferation of macrophages; dendritic cells and iNKT cells[Baseline; Day 1; Day 21; Day 28; 2-Months; 3-Months; and 6-Months.]

Sept. 1, 2021, 11 p.m. oms

Assess the safety and tolerability of EDV-plasmid-spike-GC administered intramuscularly as two doses in non-COVID-19 infected volunteers. Safety assessment will involve standard clinical monitoring of the following in hospital medical records:- Dose Limiting Toxicities and Adverse Events- Clinical Laboratory Tests (Full Blood Count; Chemistry; C-Reactive Protein; Coagulation Studies; Creatinine Clearance; Urinalysis; Cytokines)- Vital Signs- Physical Examination- 12-Lead Electrocardiogram[Baseline; Day 1; Day 21; Day 28; 3-Months; and 6-Months.];Composite assessment of immune responses of participants receiving the EDV-plasmid-spike-GC through:Serum Biochemistry and HaematologyC-Reactive ProteinIgG and IgM antibody responsesType I interferon responseType II interferon responseVirus neutralising responseCD8+ T-cell responseActivation and proliferation of macrophages; dendritic cells and iNKT cells[Baseline; Day 1; Day 21; Day 28; 3-Months; and 6-Months]

Assess the safety and tolerability of EDV-plasmid-spike-GC administered intramuscularly as two doses in non-COVID-19 infected volunteers. Safety assessment will involve standard clinical monitoring of the following in hospital medical records:- Dose Limiting Toxicities and Adverse Events- Clinical Laboratory Tests (Full Blood Count; Chemistry; C-Reactive Protein; Coagulation Studies; Creatinine Clearance; Urinalysis; Cytokines)- Vital Signs- Physical Examination- 12-Lead Electrocardiogram[Baseline; Day 1; Day 21; Day 28; 3-Months; and 6-Months.];Composite assessment of immune responses of participants receiving the EDV-plasmid-spike-GC through:Serum Biochemistry and HaematologyC-Reactive ProteinIgG and IgM antibody responsesType I interferon responseType II interferon responseVirus neutralising responseCD8+ T-cell responseActivation and proliferation of macrophages; dendritic cells and iNKT cells[Baseline; Day 1; Day 21; Day 28; 3-Months; and 6-Months]