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

Primary Purpose

COVID-19 Infection, COVID-19 Vaccine Adverse Reaction

Status
Not yet recruiting
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
LEM-mR203
Placebo
Sponsored by
Lemonex
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Infection

Eligibility Criteria

19 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Seoul National University Hospital Clinical Trials Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

LEM-mR203

Placebo

Arm Description

Drug: LEM-mR203 An intramuscular single injection prepared by mixing mRNA and DegradaBALL before administration

Drug: 0.9% Sodium Chloride Solution An intramuscular single injection prepared before administration

Outcomes

Primary Outcome Measures

Safety and Reactogenicity Assessment
Incidence rate of Acute Immediate Adverse Reactions(IAR) within 30 minutes post administration(sentinel group observed for 2 hours) Incidence rate of solicited local and systemic Adverse Events (AEs) within 7 days post-administration Incidence rate of unsolicited AEs within up to 28 days post-administration 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

Secondary Outcome Measures

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)
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
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
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
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
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
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

Full Information

First Posted
August 29, 2023
Last Updated
September 12, 2023
Sponsor
Lemonex
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1. Study Identification

Unique Protocol Identification Number
NCT06032000
Brief Title
Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronavirus 2) Booster Vaccine (LEM-mR203)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
September 2023 (Anticipated)
Primary Completion Date
January 2024 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Lemonex

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Infection, COVID-19 Vaccine Adverse Reaction

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
LEM-mR203 vs placebo
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
20 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
LEM-mR203
Arm Type
Active Comparator
Arm Description
Drug: LEM-mR203 An intramuscular single injection prepared by mixing mRNA and DegradaBALL before administration
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Drug: 0.9% Sodium Chloride Solution An intramuscular single injection prepared before administration
Intervention Type
Biological
Intervention Name(s)
LEM-mR203
Intervention Description
mRNA vaccine using Lemonex's Drug Delivery System (DDS), DegradaBALL
Intervention Type
Biological
Intervention Name(s)
Placebo
Intervention Description
0.9% Sodium Chloride Solution
Primary Outcome Measure Information:
Title
Safety and Reactogenicity Assessment
Description
Incidence rate of Acute Immediate Adverse Reactions(IAR) within 30 minutes post administration(sentinel group observed for 2 hours) Incidence rate of solicited local and systemic Adverse Events (AEs) within 7 days post-administration Incidence rate of unsolicited AEs within up to 28 days post-administration 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
Secondary Outcome Measure Information:
Title
GMT(geometric mean titer) of Anti-SARS-CoV-2 RBD(receptor-binding domain) IgG
Description
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
Title
GMFR(geometric mean fold rise) of Anti-SARS-CoV-2 RBD IgG
Description
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
Title
Proportion of participants achieving seroresponse of Anti-SARS-CoV-2 RBD IgG
Description
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
Title
GMT(geometric mean titer) of neutralizing antibody to the SARS-CoV-2 (kappa variant)
Description
GMT 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
Title
GMFR(geometric mean fold rise) of neutralizing antibody to the SARS-CoV-2 (kappa variant)
Description
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
Title
Proportion of participants achieving seroresponse of neutralizing antibody to the SARS-CoV-2 (kappa variant)
Description
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
Title
Cell-mediated Immunity (CMI)
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sun Mee Jang
Phone
82-2-875-7797
Email
smbs105@lemonex.co.kr
First Name & Middle Initial & Last Name or Official Title & Degree
Cheolhee Won, PhD
Phone
+82-2-525-7781
Email
cheolhee.won@lemonexbio.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cheolhee Won, PhD
Organizational Affiliation
Lemonex
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
In Jin Jang, MD, PhD
Organizational Affiliation
Seoul National University Hospital Clinical Trials Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Seoul National University Hospital Clinical Trials Center
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sooyoun Lee
Phone
82-2-740-4083
Email
leesu@snu.ac.kr
First Name & Middle Initial & Last Name & Degree
In Jin Jang, MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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