Created at Source Raw Value Validated value
Dec. 15, 2020, 2:47 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "RBD SARS-CoV-2 HBsAg VLP Vaccine; administered at two dose strengths; 2mcg and 5 mcg and with two different adjuvants; by intramuscular injection by Investigators (or delegate) during in-clinic visit. Phase 1 will include four cohorts; to receive two doses of a 5mcg dose of RBD antigen on Days 0 and 28 that includes Alum adjuvant alone; Alum adjuvant plus low dose CpG 1018 (150mcg) or Alum adjuvant plus high dose CpG1018 (1500mcg); or placebo on Day 0 and 28.Phase 2 will evaluate two doses of RBD antigen; 2mcg or 5mcg given 28 days apart. Participants will be randomised into one of 5 dose cohorts. These are 1) 5mcg RBD dose plus Alum adjuvant only; 2) 5mcg RBD dose with Alum adjuvant plus low dose CpG 1018; 3) 5mcg RBD dose with Alum adjuvant plus high dose CpG 1018; 4) 2mcg RBD dose with Alum adjuvant plus high dose CpG 1018; or 5) placebo.Phase 2 will commence following DSMB review of safety data from Phase 1.Two groups of participants will be enrolled. Phase 1 will include a group of healthy adults aged 18-45. Phase 2 will include a separate group of healthy adults aged 18 - 79 years.Participants will return to site 7 days from vaccine administration dates to undergo safety assessments and blood sampling for immunogenicity evaluation. Further on site assessments are conducted monthly or bi-monthly for up to 180 days from date of first vaccine administration.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 2317, "treatment_name": "Aluminium adjuvant+rbd sars-cov-2", "treatment_type": "Adjuvant+virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5mcg+low dose CpG;2;days0-28\n", "treatment_id": 2318, "treatment_name": "Aluminium adjuvant+cpg1018 adjuvant+rbd sars-cov-2", "treatment_type": "Adjuvant+virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "5mcg+high dose CpG;2;days0-28\n", "treatment_id": 2318, "treatment_name": "Aluminium adjuvant+cpg1018 adjuvant+rbd sars-cov-2", "treatment_type": "Adjuvant+virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "2mcg+high dose CpG;2;days0-28\n", "treatment_id": 2318, "treatment_name": "Aluminium adjuvant+cpg1018 adjuvant+rbd sars-cov-2", "treatment_type": "Adjuvant+virus-like particle", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]