KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers
Last updated on July 2021Recruitment
- Recruitment Status
- Recruiting
- Estimated Enrollment
- Same as current
Summary
- Conditions
- COVID-19
- Type
- Interventional
- Phase
- Phase 1Phase 2
- Design
- Allocation: RandomizedIntervention Model: Parallel AssignmentMasking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)Primary Purpose: Prevention
Participation Requirements
- Age
- Between 18 years and 85 years
- Gender
- Both males and females
Description
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization. Approximately 90 eligible healthy seronegative adults ages 18-49 years (inclusive) will be enrolled for Part A and 90 eligible healthy seronegative adults ages 50-85 years will be enrolled for Part B. Sentinel dosing (...
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization. Approximately 90 eligible healthy seronegative adults ages 18-49 years (inclusive) will be enrolled for Part A and 90 eligible healthy seronegative adults ages 50-85 years will be enrolled for Part B. Sentinel dosing (three subjects in each group) will be utilized in this FIH study. Sentinel cohorts will be used for the following groups: Part A (18-49 years) low dose Part B (50-85 years) low dose Part A (18-49 years) high dose Part B (50-85 years) high dose Overall, subjects will be randomized in a 1:1:1 ratio to receive study vaccine or placebo by IM injection on Days 1 and 22. All study visits will be conducted at the clinical sites on an outpatient basis. Subjects will participate in the study for approximately 1 year from the first dose.
Tracking Information
- NCT #
- NCT04473690
- Collaborators
- Not Provided
- Investigators
- Study Director: Hugh Haydon Kentucky BioProcessing
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