xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06032000</url>
    </required_header>
    <id_info>
      <org_study_id>LEM-mR203-101</org_study_id>
      <nct_id>NCT06032000</nct_id>
    </id_info>
    <brief_title>Evaluation of Safety and Immunogenicity of a SARS-CoV-2(Severe Acute Respiratory Syndrome Coronavirus 2) Booster Vaccine (LEM-mR203)</brief_title>
    <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</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Lemonex</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Lemonex</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A dose-escalation, double-blinded, randomized, placebo-controlled phase 1 study to assess the&#xD;
        safety, reactogenicity, and immunogenicity of a SARS-CoV-2 Booster Vaccine (LEM-mR203) in&#xD;
        healthy adults aged at 19 to 55 years&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The LEM-mR203 is a mRNA vaccine candidate using Lemonex's DDS (Drug Delivery System) named&#xD;
        DegradaBALL, and is to be evaluated as a booster vaccine for the prevention of COVID-19&#xD;
        (Coronavirus Disease 2019) in healthy volunteers. DegradaBALL is porous silica&#xD;
        nanoparticle-based Drug Delivery System and is resistant to heat and light and stable at room&#xD;
        temperature. APIs (Active Pharmaceutical Ingredients) can be loaded by simply mixing into&#xD;
        DegradaBALL at the point of use before administration unlike lipid nanoparticles (LNPs) that&#xD;
        require drug loading through manufacturing at designated facilities. The LEM-mR203 has been&#xD;
        developed to deliver Lemonex's mRNA using DegradaBALL to address the limitations of the&#xD;
        existing mRNA COVID-19 vaccines using Lipid Nanoparticle (LNP). The development aims to&#xD;
        overcome safety concerns associated with the components of LNP as well as challenges like the&#xD;
        ultra-cold storage requirements.&#xD;
  &#xD;
        This is the First-In-Human study of LEM-mR203 and consists of two dose cohorts, enrolling&#xD;
        healthy adults who will receive a single intramuscular injection of LEM-mR203. The objectives&#xD;
        of the trial are to evaluate the safety, reactogenicity, and immunogenicity of LEM-mR203. For&#xD;
        each cohort, the first three participants will be dosed with LEM-mR203, followed by a safety&#xD;
        review by the DSMB (Data Safety Monitoring Board) before enrolling the remaining&#xD;
        participants. The follow-up period will continue for up to 12 months following the&#xD;
        administration of a single dose of LEM-mR203.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2024</primary_completion_date>
    <phase>Phase 1</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>LEM-mR203 vs placebo</intervention_model_description>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Safety and Reactogenicity Assessment</measure>
      <time_frame>Baseline, 1week, 4week and 3,6 and12 months post a booster injection</time_frame>
      <description>Incidence rate of Acute Immediate Adverse Reactions(IAR) within 30 minutes post administration(sentinel group observed for 2 hours)&#xD;
  Incidence rate of solicited local and systemic Adverse Events (AEs) within 7 days post-administration&#xD;
  Incidence rate of unsolicited AEs within up to 28 days post-administration&#xD;
  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</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>GMT(geometric mean titer) of Anti-SARS-CoV-2 RBD(receptor-binding domain) IgG</measure>
      <time_frame>Baseline,1,3,6 and 12 months post a booster injection</time_frame>
      <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)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMFR(geometric mean fold rise) of Anti-SARS-CoV-2 RBD IgG</measure>
      <time_frame>Baseline,1,3,6 and 12 months post a booster injection</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants achieving seroresponse of Anti-SARS-CoV-2 RBD IgG</measure>
      <time_frame>Baseline,1,3,6 and 12 months post a booster injection</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMT(geometric mean titer) of neutralizing antibody to the SARS-CoV-2 (kappa variant)</measure>
      <time_frame>Baseline,1,3,6 and 12 months post a booster injection</time_frame>
      <description>GMT of neutralizing antibody measured by live virus neutralization assay from baseline to 1, 3, 6 and 12 months post a booster injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>GMFR(geometric mean fold rise) of neutralizing antibody to the SARS-CoV-2 (kappa variant)</measure>
      <time_frame>Baseline,1,3,6 and 12 months post a booster injection</time_frame>
      <description>GMFR of neutralizing antibody measured by live virus neutralization assay from baseline to 1, 3, 6 and 12 months post a booster injection</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of participants achieving seroresponse of neutralizing antibody to the SARS-CoV-2 (kappa variant)</measure>
      <time_frame>Baseline,1,3,6 and 12 months post a booster injection</time_frame>
      <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</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Cell-mediated Immunity (CMI)</measure>
      <time_frame>Baseline and 1 month</time_frame>
      <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</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">20</enrollment>
    <condition>COVID-19 Infection</condition>
    <condition>COVID-19 Vaccine Adverse Reaction</condition>
    <arm_group>
      <arm_group_label>LEM-mR203</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Drug: LEM-mR203&#xD;
  An intramuscular single injection prepared by mixing mRNA and DegradaBALL before administration</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Drug: 0.9% Sodium Chloride Solution&#xD;
  An intramuscular single injection prepared before administration</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>LEM-mR203</intervention_name>
      <description>mRNA vaccine using Lemonex's Drug Delivery System (DDS), DegradaBALL</description>
      <arm_group_label>LEM-mR203</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo</intervention_name>
      <description>0.9% Sodium Chloride Solution</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy volunteer aged 19 years or older but less than 55 years at the time of&#xD;
               screening.&#xD;
  &#xD;
            -  Individuals falling into one of the following categories:&#xD;
  &#xD;
                 -  Those who have completed their primary vaccination with a domestically approved&#xD;
                    COVID-19 vaccine and have elapsed more than 90 days but less than 48 weeks since&#xD;
                    the completion of the primary vaccination.&#xD;
  &#xD;
                 -  Individuals who have completed their primary vaccination and received 1 or more&#xD;
                    additional doses; these individuals must have elapsed more than 4 months but less&#xD;
                    than 48 weeks since their last vaccination&#xD;
  &#xD;
            -  Individuals who do not exhibit clinically significant respiratory symptoms (e.g.,&#xD;
               cough, sore throat) and do not have clinically significant active lesions on chest&#xD;
               X-ray.&#xD;
  &#xD;
            -  Individuals who agree to use medically accepted contraceptive methods during the&#xD;
               entire study period before clinical trials&#xD;
  &#xD;
            -  Individuals who agree not to donate blood or receive blood transfusions (including&#xD;
               whole blood, plasma components, platelet components, and platelet plasma components)&#xD;
               during the study period before clinical trials.&#xD;
  &#xD;
            -  Individuals who can participate in all study visit schedules and comply with all study&#xD;
               procedures.&#xD;
  &#xD;
            -  Individuals who, after receiving detailed explanations about the clinical trial and&#xD;
               fully comprehending it, voluntarily decide to participate, and provide written consent&#xD;
               before the screening procedure.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Within 72 hours before administration of the investigational medicinal product,&#xD;
               individuals with clinically significant respiratory symptoms (e.g., cough, sore&#xD;
               throat), acute febrile illness with body temperature exceeding 38℃, suspicion of other&#xD;
               infectious diseases, or individuals with symptoms suspected to be caused by other&#xD;
               infectious diseases.&#xD;
  &#xD;
            -  Individuals who tested positive for SARS-CoV-2 genetic test (RT-PCR) or rapid antigen&#xD;
               test during the screening.&#xD;
  &#xD;
            -  Individuals who have not elapsed 90 days since being diagnosed with COVID-19.&#xD;
  &#xD;
            -  Individuals with positive results in screening tests for Hepatitis B, Hepatitis C,&#xD;
               Syphilis (RPR), or HIV conducted during the screening.&#xD;
  &#xD;
            -  Individuals with a smoking history within 12 weeks prior to administration of the&#xD;
               investigational medicinal product or current smokers (smoking up to 10&#xD;
               cigarettes/month may be allowed based on the investigator's judgment ).&#xD;
  &#xD;
            -  Individuals with a history of malignant tumors within 5 years before administration of&#xD;
               the investigational medicinal product.&#xD;
  &#xD;
            -  Individuals with a history of generalized urticaria within 5 years before&#xD;
               administration of the investigational medicinal product.&#xD;
  &#xD;
            -  Individuals with clinically significant conditions or medical history (e.g.,&#xD;
               respiratory diseases such as asthma, chronic obstructive pulmonary disease, active&#xD;
               tuberculosis; cardiovascular diseases such as congestive heart failure, myocardial&#xD;
               infarction, coronary artery disease, uncontrolled hypertension; gastrointestinal&#xD;
               diseases such as chronic liver disease, inflammatory bowel disease; hematological and&#xD;
               neoplastic diseases, endocrine diseases such as diabetes, hyperthyroidism;&#xD;
               genitourinary diseases such as chronic urinary tract infections, chronic renal&#xD;
               failure; musculoskeletal diseases such as muscular dystrophy; neurological and&#xD;
               psychiatric diseases such as epilepsy, mood disorders, obsessive-compulsive disorder),&#xD;
               not limited to the mentioned examples.&#xD;
  &#xD;
            -  Individuals with a history of solid organ or bone marrow transplantation.&#xD;
  &#xD;
            -  Individuals with a history of congenital or acquired immunodeficiency diseases or&#xD;
               autoimmune diseases.&#xD;
  &#xD;
            -  Participants who have received any other vaccines within 4 weeks prior to the&#xD;
               investigational medicinal product or who have planned to receive other vaccines within&#xD;
               28 days after the administration of the investigational medicinal product are&#xD;
               excluded. However, exception applies to influenza vaccines&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>55 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Cheolhee Won, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Lemonex</affiliation>
    </overall_official>
    <overall_official>
      <last_name>In Jin Jang, MD, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Seoul National University Hospital Clinical Trials Center</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sun Mee Jang</last_name>
      <phone>82-2-875-7797</phone>
      <email>smbs105@lemonex.co.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Cheolhee Won, PhD</last_name>
      <phone>+82-2-525-7781</phone>
      <email>cheolhee.won@lemonexbio.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Seoul National University Hospital Clinical Trials Center</name>
        <address>
          <city>Seoul</city>
          <zip>03080</zip>
          <country>Korea, Republic of</country>
        </address>
      </facility>
      <contact>
        <last_name>Sooyoun Lee</last_name>
        <phone>82-2-740-4083</phone>
        <email>leesu@snu.ac.kr</email>
      </contact>
      <investigator>
        <last_name>In Jin Jang, MD, PhD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 29, 2023</study_first_submitted>
    <study_first_submitted_qc>September 6, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 11, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>COVID-19</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06032000
  org study id: LEM-mR203-101
  nct id: NCT06032000
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: LEM-mR203 vs placebo
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Safety and Reactogenicity Assessment
  time frame: Baseline, 1week, 4week and 3,6 and12 months post a booster injection
  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
  measure: GMT(geometric mean titer) of Anti-SARS-CoV-2 RBD(receptor-binding domain) IgG
  time frame: Baseline,1,3,6 and 12 months post a booster injection
  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)
  measure: GMFR(geometric mean fold rise) of Anti-SARS-CoV-2 RBD IgG
  time frame: Baseline,1,3,6 and 12 months post a booster injection
  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
  measure: Proportion of participants achieving seroresponse of Anti-SARS-CoV-2 RBD IgG
  time frame: Baseline,1,3,6 and 12 months post a booster injection
  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
  measure: GMT(geometric mean titer) of neutralizing antibody to the SARS-CoV-2 (kappa variant)
  time frame: Baseline,1,3,6 and 12 months post a booster injection
  description: GMT of neutralizing antibody measured by live virus neutralization assay from baseline to 1, 3, 6 and 12 months post a booster injection
  measure: GMFR(geometric mean fold rise) of neutralizing antibody to the SARS-CoV-2 (kappa variant)
  time frame: Baseline,1,3,6 and 12 months post a booster injection
  description: GMFR of neutralizing antibody measured by live virus neutralization assay from baseline to 1, 3, 6 and 12 months post a booster injection
  measure: Proportion of participants achieving seroresponse of neutralizing antibody to the SARS-CoV-2 (kappa variant)
  time frame: Baseline,1,3,6 and 12 months post a booster injection
  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
  measure: Cell-mediated Immunity (CMI)
  time frame: Baseline and 1 month
  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
  arm group label: LEM-mR203
  arm group type: Active Comparator
  description: Drug: LEM-mR203
  An intramuscular single injection prepared by mixing mRNA and DegradaBALL before administration
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Drug: 0.9% Sodium Chloride Solution
  An intramuscular single injection prepared before administration
  intervention type: Biological
  intervention name: LEM-mR203
  description: mRNA vaccine using Lemonex's Drug Delivery System (DDS), DegradaBALL
  arm group label: LEM-mR203
  intervention type: Biological
  intervention name: Placebo
  description: 0.9% Sodium Chloride Solution
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: 55 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Cheolhee Won, PhD
  role: Study Director
  affiliation: Lemonex
  last name: In Jin Jang, MD, PhD
  role: Principal Investigator
  affiliation: Seoul National University Hospital Clinical Trials Center
  last name: Sun Mee Jang
  phone: 82-2-875-7797
  email: smbs105@lemonex.co.kr
  last name: Cheolhee Won, PhD
  phone: +82-2-525-7781
  email: cheolhee.won@lemonexbio.com
  facility: 
  contact: 
  investigator: 
  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No