KBP-201 COVID-19 Vaccine Trial in Healthy Volunteers
brief summary
This is an First In Human (FIH), observer-blinded, randomized, placebo-controlled, parallel group study to evaluate the safety and immunogenicity of KBP-COVID-19 plus CPG adjuvant vaccine in healthy adult subjects in 2 age groups, Part A (18-49 years) and Part B (50-85 years).
detailed description
Subjects will be screened up to 14 days (Day -14 to Day -1) before randomization.
Approximately 90 eligible healthy 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.
official title
A Phase I/II, First-in-human, Observer-blinded, Randomized, Placebo-controlled, Parallel Group Study to Evaluate the Safety and Immunogenicity of TAP-COVID-19 SARS-CoV-2 Vaccine With CpG Adjuvant in Healthy Adults Aged 18-49 and 50-85