NCT06032000

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

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Lemonex · Industry
• Sex: All
• Age: 19 Years – 55 Years
• Healthy volunteers: Accepted

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

Detailed description

The LEM-mR203 is a mRNA vaccine candidate using Lemonex's DDS (Drug Delivery System) named DegradaBALL, and is to be evaluated as a booster vaccine for the prevention of COVID-19 (Coronavirus Disease 2019) in healthy volunteers. DegradaBALL is porous silica nanoparticle-based Drug Delivery System and is resistant to heat and light and stable at room temperature. APIs (Active Pharmaceutical Ingredients) can be loaded by simply mixing into DegradaBALL at the point of use before administration unlike lipid nanoparticles (LNPs) that require drug loading through manufacturing at designated facilities. The LEM-mR203 has been developed to deliver Lemonex's mRNA using DegradaBALL to address the limitations of the existing mRNA COVID-19 vaccines using Lipid Nanoparticle (LNP). The development aims to overcome safety concerns associated with the components of LNP as well as challenges like the ultra-cold storage requirements. This is the First-In-Human study of LEM-mR203 and consists of two dose cohorts, enrolling healthy adults who will receive a single intramuscular injection of LEM-mR203. The objectives of the trial are to evaluate the safety, reactogenicity, and immunogenicity of LEM-mR203. For each cohort, the first three participants will be dosed with LEM-mR203, followed by a safety review by the DSMB (Data Safety Monitoring Board) before enrolling the remaining participants. The follow-up period will continue for up to 12 months following the administration of a single dose of LEM-mR203.

Conditions

• COVID-19 Infection
• COVID-19 Vaccine Adverse Reaction

Interventions

Type	Name	Description
BIOLOGICAL	LEM-mR203	mRNA vaccine using Lemonex's Drug Delivery System (DDS), DegradaBALL
BIOLOGICAL	Placebo	0.9% Sodium Chloride Solution

Timeline

• Start date: 2023-11-06
• Primary completion: 2025-03-28
• Completion: 2025-03-28
• First posted: 2023-09-11
• Last updated: 2025-04-06

Locations

1 site across 1 country: South Korea