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

NCT07791186 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2026-08-28

No results posted yet for this study

Summary

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.

Conditions

  • Prevention of COVID-19 Variant (Omicron JN.1)

Interventions

BIOLOGICAL

BMI2012 low-dose

Self-amplifying RNA vaccine encoding the SARS-CoV-2 (Omicron JN.1) spike protein. Administered as a single low-dose intramuscular injection at Visit 2

OTHER

Placebo low-dose

Normal saline solution administered as a single intramuscular injection at visit 2, volume-matched to BMI2012 low-dose

BIOLOGICAL

BMI2012 mid-dose

Self-amplifying RNA vaccine encoding the SARS-CoV-2 (Omicron JN.1) spike protein. Administered as a single mid-dose intramuscular injection at Visit 2

OTHER

Placebo mid-dose

Normal saline solution administered as a single intramuscular injection at visit 2, volume-matched to BMI2012 mid-dose

BIOLOGICAL

BMI2012 high-dose

Self-amplifying RNA vaccine encoding the SARS-CoV-2 (Omicron JN.1) spike protein. Administered as a single high-dose intramuscular injection at Visit 2

OTHER

Placebo high-dose

Normal saline solution administered as a single intramuscular injection at visit 2, volume-matched to BMI2012 high-dose

Sponsors & Collaborators

  • BMI Korea

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
55 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2026-10-01
Primary Completion
2027-12-31
Completion
2027-12-31

Countries

  • South Korea

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07791186 on ClinicalTrials.gov