A dose-escalation, double-blinded, randomized, placebo-controlled phase 1 study to assessthe safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Booster Vaccine(LEM-mR203) in healthy adults aged at 19 to 55 years
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.
Biological: LEM-mR203
mRNA vaccine using Lemonex's Drug Delivery System (DDS), DegradaBALL
Biological: Placebo
0.9% Sodium Chloride Solution
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 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
Seoul National University Hospital Clinical Trials Center
Seoul, Korea, Republic of