The current platform protocol is designed to determine the safety and immunizing activity of a booster dose of 100 μg UB-612 in patients who have received a different vaccine 3 months or more before the study start (i.e., Day 1). The randomized, active-controlled multicenter study sponsored by Vaxxinity will be conducted in several countries under a master platform protocol outlining common objectives, endpoints, population, study design, and data analysis. The platform protocol is designed for multiple sub-studies to be implemented at any time, each independently addressing the same set of scientific questions aimed to evaluate the immune responses after a booster injection with UB-612 vaccine candidate and a particular comparator COVID-19 vaccine product.
This is a multicenter, international, randomized, active-controlled platform study with each sub-study designed to randomize subjects to receive a single injection with UB-612 or a comparator COVID-19 vaccine in 1:1 ratio.