Created at Source Raw Value Validated value
Aug. 5, 2021, 3:30 p.m. oms

[{"arm_notes": "", "treatment_id": null, "treatment_name": "This is a Phase I; open label; dose-escalation study of three dose levels of the SARS-CoV-2 spike antigen administered intramuscularly (IM) in combination with a fixed dosage of PIKA adjuvant vaccine to evaluate the safety; tolerability; and immunogenicity of PIKA COVID-19 vaccine candidate in healthy individuals aged 18-65 years. The study will be conducted in New Zealand at the New Zealand Clinical Research site located in the city of Christchurch.There will be 3 dose groups; 1 to 3 with escalating antigen dose with PIKA adjuvant in sequential cohorts. A total of 45 subjects will be enrolled in this study. Subjects in Group 1-3 will receive two doses of PIKA COVID-19 vaccine via IM administration on Days 1 and 8. The medical monitor and principal investigator will review the safety experience of all subjects enrolled in Group 1 through Study Day 8. Fifteen eligible subjects in each dose group will receive the study vaccine on Study Days 1 and 8 via intramuscular injection in alternative deltoid muscles. Subjects will be sequentially assigned to a dose group based on the timing of completion of screening. Enrollment of each dose cohort will start with 3 sentinel subjects; at least one male and one female. The remaining subjects will be enrolled at least 48 hours later after the 3 sentinel subjects complete the first dose administration with no safety concerns as assessed by the Principal Investigator. The Medical Monitor and Principal Investigator will review the safety data of all subjects enrolled in Group 1 through Study Day 8. If no pausing rules have been met; Group 2 will be enrolled following the enrollment practice in Group 1. Accordingly; Group 3 can be enrolled when no pausing rules are met after all subjects in Group 2 completed Day 8 visit; as", "treatment_type": "TODO", "pharmacological_treatment": "TODO"}]

[{"arm_notes": "5 ug S protein/1mg PIKA;2;days1-8;IM", "treatment_id": 2037, "treatment_name": "Pika covid-19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "10 ug S protein /1mg PIKA;2;days1-8;IM", "treatment_id": 2037, "treatment_name": "Pika covid-19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "20 ug S protein /1mg PIKA;2;days1-8;IM", "treatment_id": 2037, "treatment_name": "Pika covid-19 vaccine", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]