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 range19 Years – 55 Years
SexALL
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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 …
What they're measuring
1
Safety and Reactogenicity Assessment
Timeframe: Baseline, 1week, 4week and 3,6 and12 months post a booster injection