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
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
20
Seoul National University Hospital Clinical Trials Center
Seoul, South Korea
Safety and Reactogenicity Assessment
1. Incidence rate of Acute Immediate Adverse Reactions(IAR) within 30 minutes post administration(sentinel group observed for 2 hours) 2. Incidence rate of solicited local and systemic Adverse Events (AEs) within 7 days post-administration 3. Incidence rate of unsolicited AEs within up to 28 days post-administration 4. Incidence rate of Serious Adverse Events (SAEs), Medically Attended Adverse Events (MAAEs), Adverse Events of Special Interest (AESIs) within up to 366 days post-administration
Time frame: Baseline, 1week, 4week and 3,6 and12 months post a booster injection
GMT(geometric mean titer) of Anti-SARS-CoV-2 RBD(receptor-binding domain) IgG
GMT of Anti-SARS-CoV-2 RBD IgG from baseline to 1,3,6 and12 months post a booster injection of LEM-mR203, measured by ECLIA(Electrochemiluminescence Immunoassay)
Time frame: Baseline,1,3,6 and 12 months post a booster injection
GMFR(geometric mean fold rise) of Anti-SARS-CoV-2 RBD IgG
GMFR of Anti-SARS-CoV-2 RBD IgG from baseline to 1,3,6 and12 months post a booster injection of LEM-mR203, measured by ECLIA
Time frame: Baseline,1,3,6 and 12 months post a booster injection
Proportion of participants achieving seroresponse of Anti-SARS-CoV-2 RBD IgG
Proportion of participants achieving seroresponse(SR defined as at least 2-fold increase fro baseline) of Anti-SARS-CoV-2 RBD IgG from baseline to 1,3,6 and 12 months post a booster injection, measured by ECLIA
Time frame: Baseline,1,3,6 and 12 months post a booster injection
GMT(geometric mean titer) of neutralizing antibody to the SARS-CoV-2 (kappa variant)
GMT of neutralizing antibody measured by live virus neutralization assay from baseline to 1, 3, 6 and 12 months post a booster injection
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Time frame: Baseline,1,3,6 and 12 months post a booster injection
GMFR(geometric mean fold rise) of neutralizing antibody to the SARS-CoV-2 (kappa variant)
GMFR of neutralizing antibody measured by live virus neutralization assay from baseline to 1, 3, 6 and 12 months post a booster injection
Time frame: Baseline,1,3,6 and 12 months post a booster injection
Proportion of participants achieving seroresponse of neutralizing antibody to the SARS-CoV-2 (kappa variant)
Proportion of participants achieving seroresponse(SR defined as at least 2-fold increase from baseline) of neutralizing antibody measured by live virus from baseline to 1, 3, 6 and 12 months post a booster injection
Time frame: Baseline,1,3,6 and 12 months post a booster injection
Cell-mediated Immunity (CMI)
INF(Interferon)-γ(gamma) and IL(Interleukin)-4 confirmed using ELISPOT (Enzyme-Linked ImmunoSpot) assay, from baseline to 1 month post a booster injection
Time frame: Baseline and 1 month