Created at Source Raw Value Validated value
April 29, 2022, 10 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "44 subjects will be selected for the study and randomised into one of three groups. At least 15 subjects will receive VXS-1223 30 mcg (treatment Arm 1- active) and 15 subjects will receive VXS-1223 90 mcg (treatment Arm 2 - active). 14 subjects will receive VXS-1223U (treatment Arm 3 - placebo).To maintain the study blind; each subject will receive 3 patches:The Treatment arm 2 will receive 3 patches of VXS-1223 30mg to achieve a dose of 90mg. Subjects in Treatment arm 1 will receive 1 patch of VXS-1223 30mg and 2 patches of uncoated (placebo) VXS1223U and subjects in Treatment arm 3 will receive 3 uncoated; placebo patches of VXS1223U. The patches will be dispensed from the unblinded Pharmacist according to the Randomisation list. The receipt and administration of the patches will be recorded in the site source data files.The VXS-1223 (or placebo) in each group is delivered intradermally by a high-density microarray patch (HD-MAP) via an integrated; single-use; intradermal (ID) vaccine-delivery system; containing a mechanical; dome-spring that applies the array of micro-projections to the skin at approximately 20 m/s. The spring is actuated by pressing down on the top of the applicator with a finger and the whole delivery system (including the HD-MAP) is removed after 2 minutes (\u00b1 10 seconds) of application time. VXS-1223 (active) includes an aseptically produced 0.64 cm\u00b2 polymer array (or \u2018patch\u2019) with approximately 1;700 micro-projections; coated with 30 mcg of a modified SARS-CoV-2 spike protein (HexaPro).The HD-MAP is administered by a small number of trained individuals at the study site; to maintain consistency of application.", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "3 patches of VXS-1223 30mg ", "treatment_id": 2455, "treatment_name": "Vxs-1223", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1 patch of VXS-1223 30mg and 2 patches of uncoated (placebo) ", "treatment_id": 2455, "treatment_name": "Vxs-1223", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]