Created at Source Raw Value Validated value
Dec. 4, 2021, midnight oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "Investigational product: pEVAC-PS Doses: 1.2mg Intradermal (ID); 0.8mg ID; 0.4mg ID; 0.2mg ID Total: 36 volunteers Stage 1 Group 1: 6 volunteers; 2 doses of pEVAC-PS at 0.2mg (lowest dose) intradermally Stage 2 subject to safety and immunogenicity analysis from stage 1 after 4 weeks post 2nd dose - Primary immunogenicity target met Expanded group 1: 12 volunteers; 2 doses of pEVAC-PS at 0.2mg intradermally Review for plan of reduced dose formulation and testing if continued safety and immunogenicity targets met in expanded group - Primary immunogenicity target not met Group 2a: 9 volunteers; 2 doses of pEVAC-PS at 0.4mg intradermally PLUS Group 2b: 9 volunteers; 2 doses of pEVAC-PS at 0.8mg intradermally - Very Poor/No response Group 2a: 9 volunteers; 2 doses of pEVAC-PS at 0.8mg intradermally PLUS Group 2b: 9 volunteers; 2 doses of pEVAC-PS at 1.2mg intradermally Stage 3 subject to safety and immunogenicity analysis from stage 2 after 4 weeks post 2nd dose - Primary immunogenicity target met Group 3: 12 volunteers; 2 doses of pEVAC-PS at the dose with the best immunogenicity and reactogenicity profile from Groups 2a or 2b - Primary immunogenicity target not met at 2x 0.8mg ID Group 2c: 12 volunteers; 2 doses of pEVAC-PS at 1.2mg intradermally", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "", "treatment_id": 2554, "treatment_name": "Pevac-ps", "treatment_type": "Pan-sarbecovirus vaccine", "pharmacological_treatment": "Vaccine"}]