Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronavirus 2) Booster Vaccine (LEM-mR203)

NCT06032000 | Completed Phase 1 DMC

• 1 other identifier: LEM-mR203-101
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

A dose-escalation, double-blinded, randomized, placebo-controlled phase 1 study to assess the safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Booster Vaccine (LEM-mR203) in healthy adults aged at 19 to 55 years

Conditions

COVID-19 Infection; COVID-19 Vaccine Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Safety and Reactogenicity Assessment

  1. Incidence rate of Acute Immediate Adverse Reactions(IAR) within 30 minutes post administration(sentinel group observed for 2 hours) 2. Incidence rate of solicited local and systemic Adverse Events (AEs) within 7 days post-administration 3. Incidence rate of unsolicited AEs within up to 28 days post-administration 4. Incidence rate of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) within up to 366 days post-administration

  Baseline, 1week, 4week and 3,6 and12 months post a booster injection

Secondary Outcomes (7)

• GMT(geometric mean titer) of Anti-SARS-CoV-2 RBD(receptor-binding domain) IgG

  Baseline,1,3,6 and 12 months post a booster injection

• GMFR(geometric mean fold rise) of Anti-SARS-CoV-2 RBD IgG

  Baseline,1,3,6 and 12 months post a booster injection

• Proportion of participants achieving seroresponse of Anti-SARS-CoV-2 RBD IgG

  Baseline,1,3,6 and 12 months post a booster injection

• GMT(geometric mean titer) of neutralizing antibody to the SARS-CoV-2 (kappa variant)

  Baseline,1,3,6 and 12 months post a booster injection

• GMFR(geometric mean fold rise) of neutralizing antibody to the SARS-CoV-2 (kappa variant)

  Baseline,1,3,6 and 12 months post a booster injection

Study Arms (2)

LEM-mR203

ACTIVE COMPARATOR

Drug: LEM-mR203 An intramuscular single injection prepared by mixing mRNA and DegradaBALL before administration

Biological: LEM-mR203

Placebo

PLACEBO COMPARATOR

Drug: 0.9% Sodium Chloride Solution An intramuscular single injection prepared before administration

Biological: Placebo

Interventions

LEM-mR203 BIOLOGICAL

mRNA vaccine using Lemonex's Drug Delivery System (DDS), DegradaBALL

LEM-mR203

Placebo BIOLOGICAL

0.9% Sodium Chloride Solution

Placebo

Eligibility Criteria

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

You may qualify if:

• Healthy volunteer aged 19 years or older but less than 55 years at the time of screening.
• Individuals falling into one of the following categories:
• Those who have completed their primary vaccination with a domestically approved COVID-19 vaccine and have elapsed more than 90 days but less than 48 weeks since the completion of the primary vaccination.
• Individuals who have completed their primary vaccination and received 1 or more additional doses; these individuals must have elapsed more than 4 months but less than 48 weeks since their last vaccination
• Individuals who do not exhibit clinically significant respiratory symptoms (e.g., cough, sore throat) and do not have clinically significant active lesions on chest X-ray.
• Individuals who agree to use medically accepted contraceptive methods during the entire study period before clinical trials
• Individuals who agree not to donate blood or receive blood transfusions (including whole blood, plasma components, platelet components, and platelet plasma components) during the study period before clinical trials.
• Individuals who can participate in all study visit schedules and comply with all study procedures.
• Individuals who, after receiving detailed explanations about the clinical trial and fully comprehending it, voluntarily decide to participate, and provide written consent before the screening procedure.

You may not qualify if:

• Within 72 hours before administration of the investigational medicinal product, individuals with clinically significant respiratory symptoms (e.g., cough, sore throat), acute febrile illness with body temperature exceeding 38℃, suspicion of other infectious diseases, or individuals with symptoms suspected to be caused by other infectious diseases.
• Individuals who tested positive for SARS-CoV-2 genetic test (RT-PCR) or rapid antigen test during the screening.
• Individuals who have not elapsed 90 days since being diagnosed with COVID-19.
• Individuals with positive results in screening tests for Hepatitis B, Hepatitis C, Syphilis (RPR), or HIV conducted during the screening.
• Individuals with a smoking history within 12 weeks prior to administration of the investigational medicinal product or current smokers (smoking up to 10 cigarettes/month may be allowed based on the investigator's judgment ).
• Individuals with a history of malignant tumors within 5 years before administration of the investigational medicinal product.
• Individuals with a history of generalized urticaria within 5 years before administration of the investigational medicinal product.
• Individuals with clinically significant conditions or medical history (e.g., respiratory diseases such as asthma, chronic obstructive pulmonary disease, active tuberculosis; cardiovascular diseases such as congestive heart failure, myocardial infarction, coronary artery disease, uncontrolled hypertension; gastrointestinal diseases such as chronic liver disease, inflammatory bowel disease; hematological and neoplastic diseases, endocrine diseases such as diabetes, hyperthyroidism; genitourinary diseases such as chronic urinary tract infections, chronic renal failure; musculoskeletal diseases such as muscular dystrophy; neurological and psychiatric diseases such as epilepsy, mood disorders, obsessive-compulsive disorder), not limited to the mentioned examples.
• Individuals with a history of solid organ or bone marrow transplantation.
• Individuals with a history of congenital or acquired immunodeficiency diseases or autoimmune diseases.
• Participants who have received any other vaccines within 4 weeks prior to the investigational medicinal product or who have planned to receive other vaccines within 28 days after the administration of the investigational medicinal product are excluded. However, exception applies to influenza vaccines

Sponsors & Collaborators

• Lemonex: lead

Study Sites (1)

Seoul National University Hospital Clinical Trials Center

Seoul, 03080, 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

Study Officials

• Cheolhee Won, PhD

  Lemonex

  STUDY DIRECTOR

• In Jin Jang, MD, PhD

  Seoul National University Hospital Clinical Trials Center

  PRINCIPAL INVESTIGATOR

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

Model Details: LEM-mR203 vs placebo

Study Record Dates

• First Submitted: August 29, 2023
• First Posted: September 11, 2023
• Study Start: November 6, 2023
• Primary Completion: March 28, 2025
• Study Completion: March 28, 2025
• Last Updated: April 6, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)