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

NCT07791186 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: BMI2012-SIT-01
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 3

Brief 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)

Keywords

Omicron JN.1; Self-Amplifying RNA Vaccine; BMI2012; COVID-19

Outcome Measures

Primary Outcomes (1)

• Incidence of Adverse Events Following Investigational Product Administration

  From administration through Day 28

Secondary Outcomes (3)

• Incidence of Long-Term SAEs, MAAEs, and AESIs

  From administration through Week 52

• Clinical Safety Assessments

  From baseline through the last scheduled clinical safety assessment

• Humoral and Cell-Mediated Immune Response to BMI2012

  Day 28, Week 26, and Week 52 after administration

Study Arms (6)

Low-dose treatment

EXPERIMENTAL

Biological: BMI2012 low-dose

Low-dose placebo control

PLACEBO COMPARATOR

Other: Placebo low-dose

Mid-dose treatment

EXPERIMENTAL

Biological: BMI2012 mid-dose

Mid-dose placebo control

PLACEBO COMPARATOR

Other: Placebo mid-dose

High-dose treatment

EXPERIMENTAL

Biological: BMI2012 high-dose

High-dose placebo control

PLACEBO COMPARATOR

Other: Placebo high-dose

Interventions

BMI2012 low-dose BIOLOGICAL

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

Low-dose treatment

Placebo low-dose OTHER

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

Low-dose placebo control

BMI2012 mid-dose BIOLOGICAL

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

Mid-dose treatment

Placebo mid-dose OTHER

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

Mid-dose placebo control

BMI2012 high-dose BIOLOGICAL

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

High-dose treatment

Placebo high-dose OTHER

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

High-dose placebo control

Eligibility Criteria

• Age: 19 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female, aged 19 to 55 years, who voluntarily decides to participate in this study and provides written informed consent
• Meets at least one of the following:
• (1) At least 3 months have elapsed since the last COVID-19 vaccine administration
• (2)At least 3 months have elapsed since a confirmed diagnosis of COVID-19
• Subjects with a body mass index (BMI) between 18kg/m² and 30 kg/m², inclusive at the screening visit
• Male and female subjects of reproductive potential who have been using a highly effective method of contraception from at least 14 days prior to the screening visit and agree to continue using a highly effective method of contraception\*\* up to 12 weeks after IP administration \*Male subjects: Sexual abstinence, or the use of a condom, with the partner of reproductive potential using a highly effective method of contraception\*\* \*Female subjects: Use of a highly effective method of contraception\*\*
• Highly effective methods of contraception are as follows:
• Hormonal contraception associated with inhibition of ovulation
• Intrauterine device (IUD)
• Intrauterine hormone-releasing system (IUS)
• Bilateral tubal occlusion
• Bilateral tubal ligation
• Bilateral tubal resection/salpingectomy
• Vasectomized partner
• Sexual abstinence

You may not qualify if:

• Subjects with a positive rapid antigen test result for COVID-19 at screening
• Subjects currently receiving an approved medicinal product for the treatment or prevention of COVID-19
• Subjects who have had close contact with a person infected with COVID-19, or who have been classified as a confirmed or suspected case of COVID-19, within 14 days prior to IP administration
• Healthcare professionals who may have direct involvement in care of patients confirmed with COVID-19
• Subjects with clinically significant abnormal findings on clinical laboratory tests, electrocardiogram (ECG), or chest X-ray performed at the screening visit
• Subjects with a positive result for any of the following at screening: HIV test, hepatitis B test, or hepatitis C test
• Subjects who had an acute febrile illness with a body temperature of 38°C or higher within 72 hours prior to IP administration, or who are suspected of having another related infectious disease, or who had symptoms due to another infectious disease (such as cough, dyspnea, chills, myalgia, headache, sore throat, anosmia, or ageusia) within the same period
• Subjects judged by the investigator to be unable to participate due to any of the following serious medical or psychiatric conditions:
• (1) Respiratory disease: Asthma, chronic obstructive pulmonary disease (COPD), active tuberculosis, latent tuberculosis under treatment, or other respiratory diseases requiring daily medication; or subjects who have received treatment for exacerbation of the above respiratory diseases within 5 years prior to IP administration
• (2) Serious cardiovascular disease: Congestive heart failure, coronary artery disease, myocardial infarction, uncontrolled hypertension, thrombocytopenic or venous thrombosis, capillary leak syndrome, myocarditis, pericarditis, etc.
• (3) Neurological disease: Epilepsy, seizure disorder (within 3 years prior to IP administration), migraine, stroke, encephalopathy, Guillain-Barré syndrome, encephalomyelitis, transverse myelitis, etc.
• (4) History of malignancy within 5 years prior to IP administration (excluding basal cell carcinoma and squamous cell carcinoma of the skin)
• (5) Autoimmune disease, including autoimmune hypothyroidism and psoriasis
• (6) Immunodeficiency disease
• (7) Uncontrolled diabetes mellitus despite appropriate treatment ( HbA1c \> 7% at screening)

Sponsors & Collaborators

• BMI Korea: lead

Study Sites (3)

Hallym University Kangnam St.Heart Hospital

Seoul, South Korea

Location

Korea University Guro Hospital

Seoul, South Korea

Location

Ajou University Medical Center

Suwon, South Korea

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Professor. Song

CONTACT

82-2-2626-1114; infection@korea.ac.kr

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 27, 2026
• Study Start (Estimated): October 1, 2026
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

KR (3)