Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronav… (NCT06032000) | Clinical Trial Compass
CompletedPhase 1
Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronavirus 2) Booster Vaccine (LEM-mR203)
South Korea20 participantsStarted 2023-11-06
Plain-language 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
Who can participate
Age range
19 Years – 55 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Within 72 hours before administration of the investigational …
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Safety and Reactogenicity Assessment
Timeframe: Baseline, 1week, 4week and 3,6 and12 months post a booster injection