Safety, Tolerability, and Immunogenicity of BMI2012 Against COVID-19 Variant in Healthy Adults Aged 19 and 55 Years

This Phase 1, multi‐center, randomized, double‐blind, placebo‐controlled, dose‐escalationstudy evaluates the safety, tolerability, and immunogenicity of BMI2012, aself‐amplifying RNA vaccine candidate targeting the SARS‐CoV‐2 Omicron JN .1 variant, inhealthy adults aged 19 to 55 years.Participants will be enrolled sequentially into three ascending‐dose cohorts andrandomized within each cohort to receive a single intramuscular injection of BMI2012 orplacebo. A sentinel dosing strategy with staggered administration will be used to monitorsafety before enrollment of the remaining participants in each dose cohort. A Data SafetyMonitoring Board (DSMB) will review safety data to determine whether enrollment maycontinue and to assess dose levels appropriate for further clinical development.The primary objective is to assess the safety and tolerability of BMI2012 across the doselevels studied. Secondary objectives include exploratory evaluation of humoral andcell‐mediated immune responses to BMI2012 through 52 weeks after vaccination.