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

[{"arm_notes": "", "treatment_id": null, "treatment_name": "The study has three components: 1. Open-label; non-randomised dose escalation: 15 participants age 18-45 will be in the dose-escalation component. This will be carried out in a single centre. 1.1. The first participant will receive 0.1 \u00b5g and be invited to enter information on local and systemic reactions; into an online diary; that evening and daily thereafter for 6 days 1.2. At 48 hours post-vaccination the team will call the first participant and go through their diary. If the reactions are Grade 1-2; or transient Grade 3 that resolve within 24 hours; three further participants will receive 0.1 \u00b5g 1.3. At 48 hours post-vaccination the team will call participants 2; 3 and 4 and go through their diaries. Provided there are none of the safety concerns outlined above; a fifth participant will proceed to receive the next dose (0.3 \u00b5g) 1.4. The steps described above will be repeated in order to escalate to the highest dose (1.0 \u00b5g): the sentinel at 0.3 \u00b5g will be followed by three more participants at the same dose; provided there are none of the safety concerns outlined above at 48 hours post-vaccination of the sentinel; and a sentinel at 1.0 \u00b5g will follow if there are none of the safety concerns outlined above at 48 hours post-vaccination of the participants at 0.3 \u00b5g 1.5. Participants will be followed up for 52 weeks in total 2. Randomised dose evaluation: 105 individuals aged 18-45 will be enrolled through a single centre. Participants and laboratory staff will be blind to allocation. 2.1. Participants will be allocated in a 1:1:1 ratio to the three different doses based on block randomisation. They will be followed up for", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "1", "treatment_id": 739, "treatment_name": "Lnp-ncovsarna", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1", "treatment_id": 739, "treatment_name": "Lnp-ncovsarna", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1", "treatment_id": 739, "treatment_name": "Lnp-ncovsarna", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]