Clinical Research Directory

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-escalation study evaluates the safety, tolerability, and immunogenicity of BMI2012, a self-amplifying RNA vaccine candidate targeting the SARS-CoV-2 Omicron JN .1 variant, in healthy adults aged 19 to 55 years. Participants will be enrolled sequentially into three ascending-dose cohorts and randomized within each cohort to receive a single intramuscular injection of BMI2012 or placebo. A sentinel dosing strategy with staggered administration will be used to monitor safety before enrollment of the remaining participants in each dose cohort. A Data Safety Monitoring Board (DSMB) will review safety data to determine whether enrollment may continue and to assess dose levels appropriate for further clinical development. The primary objective is to assess the safety and tolerability of BMI2012 across the dose levels studied. Secondary objectives include exploratory evaluation of humoral and cell-mediated immune responses to BMI2012 through 52 weeks after vaccination.