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

NCT06032000 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2025-04-06

No results posted yet for this study

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

Interventions

BIOLOGICAL

LEM-mR203

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

BIOLOGICAL

Placebo

0.9% Sodium Chloride Solution

Sponsors & Collaborators

  • Lemonex

    lead INDUSTRY

Principal Investigators

  • Cheolhee Won, PhD · Lemonex

  • In Jin Jang, MD, PhD · Seoul National University Hospital Clinical Trials Center

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
2023-11-06
Primary Completion
2025-03-28
Completion
2025-03-28

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

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 NCT06032000 on ClinicalTrials.gov