Created at Source Raw Value Validated value
May 27, 2021, 12:45 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Group 1: CIGB-669 (50 \u00b5g RBD + 40 \u00b5g AgnHB); In each administration (nasal spray) the dose of the product is 200 \u00b5L (100 \u00b5L for each nostril) corresponding to 50 \u00b5g of receptor-binding domain (RBD) recombinant protein and 40 \u00b5g of nucleocapsid antigen of the virus. hepatitis B (AgnHB); without adjuvant or preservation; short scheme: 0 (nasal) - 14 (nasal) - 28 (nasal) days.Group 2: CIGB-669 (RBD 50 \u00b5g + AgnHB 40 \u00b5g) intranasally (nasal spray) 200 \u00b5L (100 \u00b5L for each nostril); long scheme: 0 (nasal) - 28 (nasal) - 56 (nasal) days.Group 3: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region in the 1st dose; followed by another two doses with CIGB-669 (RBD 50 \u00b5g + AgnHB 40 \u00b5g) intranasally (nasal spray) 200 \u00b5L (100 \u00b5L for each nostril) ; short scheme: 0 (intramuscular) - 14 (nasal) - 28 (nasal) days.Group 4: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region in the 1st dose; followed by another two doses with CIGB-669 (RBD 50 \u00b5g + AgnHB 40 \u00b5g) intranasally (nasal spray) 200 \u00b5L (100 \u00b5L for each nostril) ; long scheme: 0 (intramuscular) - 28 (nasal) - 56 (nasal) days.These interventions will be carried out during the first stage (phase I). Subsequently; an intermediate analysis will be carried out where doses and immunization schedules for phase II will be defined.;Immunogenicity; Vaccine;Immunotherapy; Active;Vaccination;Nasal Sprays ;Injections; Intramuscular;Administration; Intranasal ;CIGB-669; CIGB-66", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "50 \u00b5g + 40 \u00b5g;3 (day0-14-28)", "treatment_id": 1976, "treatment_name": "Cigb-669", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "50 \u00b5g + 40 \u00b5g;3 (day0-28-56)", "treatment_id": 1976, "treatment_name": "Cigb-669", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "(50 mcg + 0.30mg)+2(50\u00b5g + 40\u00b5g);3 (day0-14-28)", "treatment_id": 1977, "treatment_name": "Cigb-66+cigb-669", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "(50 mcg + 0.30mg)+2(50 \u00b5g + 40 \u00b5g);3 (day0-28-56)", "treatment_id": 1977, "treatment_name": "Cigb-66+cigb-669", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]

Dec. 5, 2020, 12:45 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Group 1: CIGB-669 (50 ug RBD + 40 ug AgnHB); In each administration (nasal spray) the dose of the product is 200 uL (100 uL for each nostril) corresponding to 50 ug of receptor-binding domain (RBD) recombinant protein and 40 ug of nucleocapsid antigen of the virus. hepatitis B (AgnHB); without adjuvant or preservation; short scheme: 0 (nasal) - 14 (nasal) - 28 (nasal) days. Group 2: CIGB-669 (RBD 50 ug + AgnHB 40 ug) intranasally (nasal spray) 200 uL (100 uL for each nostril); long scheme: 0 (nasal) - 28 (nasal) - 56 (nasal) days. Group 3: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region in the 1st dose; followed by another two doses with CIGB-669 (RBD 50 ug + AgnHB 40 ug) intranasally (nasal spray) 200 uL (100 uL for each nostril) ; short scheme: 0 (intramuscular) - 14 (nasal) - 28 (nasal) days. Group 4: CIGB-66 (RBD 50 mcg + aluminum hydroxide 0.30 mg); 0.5 mL intramuscularly in the deltoid region in the 1st dose; followed by another two doses with CIGB-669 (RBD 50 ug + AgnHB 40 ug) intranasally (nasal spray) 200 uL (100 uL for each nostril) ; long scheme: 0 (intramuscular) - 28 (nasal) - 56 (nasal) days. These interventions will be carried out during the first stage (phase I). Subsequently; an intermediate analysis will be carried out where doses and immunization schedules for phase II will be defined.;Immunogenicity; Vaccine;CIGB-669; CIGB-66", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]