Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "RBD SARS-CoV-2 HBsAg VLP Vaccine; administered at two dose amounts; 5mcg and 25 mcg; by intramuscular injection by Investigators (or delegate) during in-clinic visit. Phase 1 will include three cohorts; to receive either 5mcg dose on Day 0 and 28; 25mcg dose on Days 0 and 28 or placebo on Day 0 and 28. Phase 2 will evaluate both dose amounts either as single dose (given at day 0; with placebo at Day 28) or two doses (at Days 0 and 28). Participants will be randomised into one of 5 cohorts. These are 1) 5mcg dose administered on Days 0 and 28; 2) 25mcg dose administered on Days 0 and 28; 3) 5mcg dose administered on Days 0 and placebo on Day 28; 4) 25mcg dose administered on Days 0 and placebo on Day 28; or 5) placebo on day 0 and 28.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 at day 7 and 14 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": "1 or 2", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}, {"arm_notes": "1 or 2", "treatment_id": 1070, "treatment_name": "Rbd sars-cov-2 hbsag vlp vaccine", "treatment_type": "Virus-like particle", "pharmacological_treatment": "Vaccine"}]