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/NCT05993325</url>
    </required_header>
    <id_info>
      <org_study_id>COVENT-202</org_study_id>
      <nct_id>NCT05993325</nct_id>
    </id_info>
    <brief_title>Immunogenicity and Safety of AdCLD-CoV19-1 OMI as a Booster: A COVID-19 Preventive Vaccine in Healthy Volunteers</brief_title>
    <acronym>COVID-19</acronym>
    <official_title>A Phase III Multinational, Multicenter, Observer-Blinded, Randomized, Active-Controlled Trial to Evaluate the Immunogenicity and Safety of the Preventive COVID-19 Vaccine AdCLD-CoV19-1 OMI Administered as a Booster to Adults Aged 19 Years Old and Above</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Cellid Co., Ltd.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Cellid Co., Ltd.</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>
        The immunogenicity and safety of AdCLD-CoV19-1 OMI (5.0x10^10 VP (0.5 mL)/dose/Vial)&#xD;
        administered as a booster in healthy adults aged 19 years old and above will be evaluated.&#xD;
        Outcome assessment will be performed in comparison with Comirnaty Bivalent.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">May 2025</completion_date>
    <primary_completion_date type="Anticipated">May 2024</primary_completion_date>
    <phase>Phase 3</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>
      <primary_purpose>Prevention</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Ratio of GMT of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration</measure>
      <time_frame>At 28 days post IP administration</time_frame>
      <description>Ratio of GMT of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration (GMT of AdCLD-CoV19-1 OMI / GMT of Comirnaty Bivalent).&#xD;
  Geometric mean titer (GMT): The value of multiplying the antibody titer of all available subjects (N) and take the Nth order root value.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Difference in seroresponse rate (SRR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration</measure>
      <time_frame>At 28 days post IP administration</time_frame>
      <description>Difference in seroresponse rate (SRR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration (SRR of AdCLD-CoV19-1 OMI - SRR of Comirnaty Bivalent).&#xD;
  Seroresponse rate (SRR): Proportion of subjects whose antibody titer rise at least 4-fold at the measurement point compared to baseline. The titer is defined as half of detection limit if the titer before administration is below detection limit.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>SRR (proportion of subject who achieved seroresponse), GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</measure>
      <time_frame>At 26, 52 weeks post IP administration</time_frame>
      <description>SRR (proportion of subject who achieved seroresponse), GMT (Geometric mean titer), GMFR (Ratio of GMT or GMC rise at the measurement point compared to baseline) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by serostatus of SARS-CoV-2 N protein antibody.</measure>
      <time_frame>At 28 days post IP administration</time_frame>
      <description>Differences in seroresponse rate (SRR), geometric mean titer (GMT), geometric mean fold rise (GMFR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by serostatus of SARS-CoV-2 N protein antibody.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Differences in SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by country.</measure>
      <time_frame>At 28 days post IP administration</time_frame>
      <description>Differences in seroresponse rate (SRR), geometric mean titer (GMT), geometric mean fold rise (GMFR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by country.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of immediate adverse events (AE)</measure>
      <time_frame>Within 30 minutes post IP administraiton</time_frame>
      <description>Immediate adverse events occurred within 30 minutes (2 hours for ≥75 years old) post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of solicited local and systemic AE</measure>
      <time_frame>Within 7 days (Days 0 - 6) post IP administration</time_frame>
      <description>Solicited AEs occurred within 7 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of unsolicited AE</measure>
      <time_frame>Within 28 days (Days 0 - 27) post IP administration</time_frame>
      <description>Unsolicited AEs occurred within 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of SAE</measure>
      <time_frame>Throughout the study duration, 12 months post IP administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Adverse Event Of Special Interest (AESI)</measure>
      <time_frame>Throughout the study duration, 12 months post IP administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of Medically-Attended Adverse Events (MAAE)</measure>
      <time_frame>Throughout the study duration, 12 months post IP administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of clinically significant changes in clinical laboratory tests</measure>
      <time_frame>At 28 days post IP administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of clinically significant changes in vital signs</measure>
      <time_frame>At 28 days post IP administration</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of clinically significant changes in physical examination</measure>
      <time_frame>At 28 days post IP administration</time_frame>
    </secondary_outcome>
    <other_outcome>
      <measure>SRR, GMT, GMFR of SARS-CoV-2 Wuhan strain and Variants of concern (VOC) neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</measure>
      <time_frame>At 28 days post IP administration</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 S protein-specific antibody measured by ELISA at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</measure>
      <time_frame>At 28 days post IP administration</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Cellular immune response (CMI) measured by ELISpot at 28 days, 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</measure>
      <time_frame>At 28 days, 26, 52 weeks post IP administration.</time_frame>
      <description>Cellular immune response (CMI: responder rate, spot-forming unit) measured by ELISpot at 28 days, 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.</description>
    </other_outcome>
    <other_outcome>
      <measure>Differences of SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by previous COVID-19 vaccination series.</measure>
      <time_frame>At 28 days post IP administration</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Differences of SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by age.</measure>
      <time_frame>At 28 days post IP administration</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Proportion of COVID-19 cases confirmed by antigen test from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.</measure>
      <time_frame>Throughout the study duration, 12 months post IP administration</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Proportion of severe COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.</measure>
      <time_frame>Throughout the study duration, 12 months post IP administration</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Proportion of hospitalization due to COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.</measure>
      <time_frame>Throughout the study duration, 12 months post IP administration</time_frame>
    </other_outcome>
    <other_outcome>
      <measure>Proportion of mortality due to COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.</measure>
      <time_frame>Throughout the study duration, 12 months post IP administration</time_frame>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">4000</enrollment>
    <condition>COVID-19</condition>
    <condition>Vaccines</condition>
    <arm_group>
      <arm_group_label>1 dose of AdCLD-CoV19-1 OMI</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Test group will receive 1 dose of AdCLD-CoV19-1 OMI</description>
    </arm_group>
    <arm_group>
      <arm_group_label>1 dose of Comirnaty Bivalent</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Control group will receive 1 dose of Comirnaty Bivalent</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>AdCLD-CoV19-1 OMI</intervention_name>
      <description>3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle</description>
      <arm_group_label>1 dose of AdCLD-CoV19-1 OMI</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)</intervention_name>
      <description>1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle</description>
      <arm_group_label>1 dose of Comirnaty Bivalent</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Individual aged 19 and above and willing to provide written informed consent to&#xD;
               participate study voluntarily.&#xD;
  &#xD;
            2. Individual fall under one or more of the following at the date of IP administration&#xD;
  &#xD;
                 -  At least past 16 weeks (112 days) without additional COVID-19 vaccination since&#xD;
                    the last COVID-19 vaccination.&#xD;
  &#xD;
                 -  At least past 16 weeks (112 days) since the release of quarantine due to COVID-19&#xD;
                    confirmation.&#xD;
  &#xD;
            3. Individual who agrees to use medically acceptable contraceptive methods† for at least&#xD;
               4 weeks prior to screening and 12 weeks post IP administration.&#xD;
  &#xD;
            4. Individual who agrees not to donate or transfuse blood (including whole blood, plasma&#xD;
               components, platelet components, platelet plasma components) throughout the study&#xD;
               participation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            1. Individual fall under one or more of the following at the date of IP administration&#xD;
  &#xD;
                 -  History of COVID-19 within 16 weeks (-111~0 days) or considered to be infected&#xD;
                    prior to IP administration.&#xD;
  &#xD;
                 -  History of receiving COVID-19 vaccine within 16 weeks (-111~0 days) prior to IP&#xD;
                    administration.&#xD;
  &#xD;
            2. Clinically significant abnormalities on clinical laboratory tests, electrocardiograms,&#xD;
               and chest X-rays performed during screening visit.&#xD;
  &#xD;
            3. Positive HIV test result on the screening test.&#xD;
  &#xD;
            4. Acute febrile illness with (≥38°C), or any suspected infectious diseases, or&#xD;
               COVID-19-like symptoms (cough, shortness of breath, chills, myalgia, headache, sore&#xD;
               throat, loss of taste/smell, etc.) within 3 days prior to administration of IP.&#xD;
  &#xD;
            5. Any serious medical or psychiatric disease which in opinion of investigator judges&#xD;
               unable to participate.&#xD;
  &#xD;
                 -  Respiratory diseases: Asthma, Chronic Obstructive Pulmonary Disease (COPD),&#xD;
                    active or latent tuberculosis which require medication, or individual who has&#xD;
                    received treatment due to worsening of the listed respiratory disease within 5&#xD;
                    years prior to administration of IP.&#xD;
  &#xD;
                 -  Serious cardiovascular diseases: Congestive heart failure, coronary artery&#xD;
                    disease, myocardial infarction, uncontrolled hypertension, thrombocytopenia or&#xD;
                    venous thrombosis, capillary leakage syndrome, myocarditis, pericarditis, etc.&#xD;
  &#xD;
                 -  Neurologic diseases: Epilepsy, seizure within past 3 years, migraine, stroke,&#xD;
                    encephalopathy, Guillain-Barre Syndrome, encephalomyelitis, transverse myelitis,&#xD;
                    etc.&#xD;
  &#xD;
                 -  Malignant cancer diagnosed within past 5 years (skin basal cell and squamous cell&#xD;
                    carcinoma are excluded).&#xD;
  &#xD;
                 -  Immune function disorders including autoimmune hypothyroidism, psoriasis.&#xD;
  &#xD;
                 -  Immunodeficiency diseases.&#xD;
  &#xD;
                 -  History of dependently administering psychotropic drugs or narcotic analgesics&#xD;
                    within 24 weeks prior to administration of IP, or psychiatric disease or&#xD;
                    behavioral impairment that, in the opinion of the investigator, could interfere&#xD;
                    with the participant's ability to participate in the study.&#xD;
  &#xD;
                 -  Other hepatobiliary, renal, endocrine, urinary tract, muscular skeletal diseases&#xD;
                    which the investigator considers clinically significant.&#xD;
  &#xD;
            6. History of splenectomy.&#xD;
  &#xD;
            7. Known history of allergic or hypersensitivity to the components of IP.&#xD;
  &#xD;
            8. Known history of serious adverse reaction, allergies or hypersensitivity related to&#xD;
               vaccination.&#xD;
  &#xD;
            9. Individual with history of bleeding diathesis or thrombocytopenia, or history of&#xD;
               severe bleeding or bruising after intramuscular injection or venipuncture or is&#xD;
               receiving an anticoagulant (Individual receiving low dose aspirin (less than&#xD;
               100mg/day) can be enrolled in judgement of investigator).&#xD;
  &#xD;
           10. History of hereditary or idiopathic angioneurotic edema.&#xD;
  &#xD;
           11. History of systemic urticaria within 5 years prior to administration of IP.&#xD;
  &#xD;
           12. Individual with history of solid organ or bone marrow transplantation.&#xD;
  &#xD;
           13. Individual who is suspected or with history of drug or alcohol abuse within 24 weeks&#xD;
               prior to administration of IP.&#xD;
  &#xD;
           14. History of licensed drug for COVID-19 prevention aside from COVID-19 vaccine within 52&#xD;
               weeks prior to administration of IP.&#xD;
  &#xD;
           15. Use of immunosuppressive or chronic use of systemic steroids within 6 weeks prior to&#xD;
               administration of IP (Topical steroids, nasal spray and inhalers are allowed).&#xD;
  &#xD;
                 -  Immunosuppressive: Azathioprine, Cyclosporine, Interferon, G-CSF, Tacrolimus,&#xD;
                    Everolimus, Sirolimus, Cyclophosphamide, 6-Mercaptopurine, Methotrexate,&#xD;
                    Rapamycin, Leflunomide, etc.&#xD;
  &#xD;
                 -  Chronic steroid: &gt;10 mg/day prednisone equivalent for periods exceeding 14 days.&#xD;
  &#xD;
           16. Individual who has administered other investigational product or device within 24&#xD;
               weeks prior to screening visit.&#xD;
  &#xD;
           17. Individual who has received or planned to receive any other vaccines within 28 days&#xD;
               prior and after the administration of IP (Flu vaccines can be administered up to 14&#xD;
               days prior to the date of IP administration).&#xD;
  &#xD;
           18. Receipt of immunoglobulin or blood-derived products within 12 weeks prior to&#xD;
               administration of IP.&#xD;
  &#xD;
           19. Individual with scheduled surgery throughout the study period.&#xD;
  &#xD;
           20. Pregnant or lactating women.&#xD;
  &#xD;
           21. Individual directly related to the investigator and meets the following:&#xD;
  &#xD;
                 -  Personnel relationship or subordinate-superior relationship (employees of the&#xD;
                    investigator's department, staffs of this trial).&#xD;
  &#xD;
                 -  Students or researchers in the immediate department of the school to which the&#xD;
                    investigator belongs (e.g., medical university).&#xD;
  &#xD;
           22. Individual who is unfit for this study for any other reason in judgement of&#xD;
               investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>19 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Wuhyun Kim, D.V.M</last_name>
      <email>whkim@cellid.co.kr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Hayeon Joo, Bachelor</last_name>
      <email>hyjoo@cellid.co.kr</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Dong-a University Hospital</name>
        <address>
          <city>Busan</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Kyungpook National University Hospital</name>
        <address>
          <city>Daegu</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Chungnam National University Hospital</name>
        <address>
          <city>Daejeon</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Chonnam National University Hospital</name>
        <address>
          <city>Gwangju</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hallym University Dongtan Sacred Heart Hospital</name>
        <address>
          <city>Gyeonggi-do</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Korea University Ansan Hospital</name>
        <address>
          <city>Gyeonggi-do</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea, ST. Vincent's Hospital</name>
        <address>
          <city>Gyeonggi-do</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Gachon University Gil Medical Center</name>
        <address>
          <city>Incheon</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Inha University Hospital</name>
        <address>
          <city>Incheon</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Hallym University Kangnam Sacred Heart Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Korea University Guro Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Samyook Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>The Catholic University of Korea, Eunpyeong St. Mary's Hospital</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>Veterans Health Service Medical Center</name>
        <address>
          <city>Seoul</city>
          <country>Korea, Republic of</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Korea, Republic of</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 14, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 15, 2023</study_first_posted>
    <last_update_submitted>August 15, 2023</last_update_submitted>
    <last_update_submitted_qc>August 15, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>COVID-19</keyword>
    <keyword>SARS-CoV-2</keyword>
    <keyword>Omicron</keyword>
    <keyword>B.1.1.529</keyword>
    <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/NCT05993325
  org study id: COVENT-202
  nct id: NCT05993325
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  The immunogenicity and safety of AdCLD-CoV19-1 OMI (5.0x10^10 VP (0.5 mL)/dose/Vial)
        administered as a booster in healthy adults aged 19 years old and above will be evaluated.
        Outcome assessment will be performed in comparison with Comirnaty Bivalent.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Triple (Participant, Care Provider, Investigator)
  measure: Ratio of GMT of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration
  time frame: At 28 days post IP administration
  description: Ratio of GMT of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration (GMT of AdCLD-CoV19-1 OMI / GMT of Comirnaty Bivalent).
  Geometric mean titer (GMT): The value of multiplying the antibody titer of all available subjects (N) and take the Nth order root value.
  measure: Difference in seroresponse rate (SRR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration
  time frame: At 28 days post IP administration
  description: Difference in seroresponse rate (SRR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration (SRR of AdCLD-CoV19-1 OMI - SRR of Comirnaty Bivalent).
  Seroresponse rate (SRR): Proportion of subjects whose antibody titer rise at least 4-fold at the measurement point compared to baseline. The titer is defined as half of detection limit if the titer before administration is below detection limit.
  measure: SRR (proportion of subject who achieved seroresponse), GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  time frame: At 26, 52 weeks post IP administration
  description: SRR (proportion of subject who achieved seroresponse), GMT (Geometric mean titer), GMFR (Ratio of GMT or GMC rise at the measurement point compared to baseline) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  measure: Differences in SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by serostatus of SARS-CoV-2 N protein antibody.
  time frame: At 28 days post IP administration
  description: Differences in seroresponse rate (SRR), geometric mean titer (GMT), geometric mean fold rise (GMFR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by serostatus of SARS-CoV-2 N protein antibody.
  measure: Differences in SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by country.
  time frame: At 28 days post IP administration
  description: Differences in seroresponse rate (SRR), geometric mean titer (GMT), geometric mean fold rise (GMFR) of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by country.
  measure: Proportion of immediate adverse events (AE)
  time frame: Within 30 minutes post IP administraiton
  description: Immediate adverse events occurred within 30 minutes (2 hours for ≥75 years old) post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  measure: Proportion of solicited local and systemic AE
  time frame: Within 7 days (Days 0 - 6) post IP administration
  description: Solicited AEs occurred within 7 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  measure: Proportion of unsolicited AE
  time frame: Within 28 days (Days 0 - 27) post IP administration
  description: Unsolicited AEs occurred within 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  measure: Proportion of SAE
  time frame: Throughout the study duration, 12 months post IP administration
  measure: Proportion of Adverse Event Of Special Interest (AESI)
  time frame: Throughout the study duration, 12 months post IP administration
  measure: Proportion of Medically-Attended Adverse Events (MAAE)
  time frame: Throughout the study duration, 12 months post IP administration
  measure: Proportion of clinically significant changes in clinical laboratory tests
  time frame: At 28 days post IP administration
  measure: Proportion of clinically significant changes in vital signs
  time frame: At 28 days post IP administration
  measure: Proportion of clinically significant changes in physical examination
  time frame: At 28 days post IP administration
  measure: SRR, GMT, GMFR of SARS-CoV-2 Wuhan strain and Variants of concern (VOC) neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  time frame: At 28 days post IP administration
  measure: SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 S protein-specific antibody measured by ELISA at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  time frame: At 28 days post IP administration
  measure: Cellular immune response (CMI) measured by ELISpot at 28 days, 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  time frame: At 28 days, 26, 52 weeks post IP administration.
  description: Cellular immune response (CMI: responder rate, spot-forming unit) measured by ELISpot at 28 days, 26, 52 weeks post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration.
  measure: Differences of SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by previous COVID-19 vaccination series.
  time frame: At 28 days post IP administration
  measure: Differences of SRR, GMT, GMFR of SARS-CoV-2 B.1.1.529 neutralizing antibody measured by wild-type virus neutralization assay at 28 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration by age.
  time frame: At 28 days post IP administration
  measure: Proportion of COVID-19 cases confirmed by antigen test from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.
  time frame: Throughout the study duration, 12 months post IP administration
  measure: Proportion of severe COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.
  time frame: Throughout the study duration, 12 months post IP administration
  measure: Proportion of hospitalization due to COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.
  time frame: Throughout the study duration, 12 months post IP administration
  measure: Proportion of mortality due to COVID-19 cases from 14 days post AdCLD-CoV19-1 OMI or Comirnaty Bivalent administration to the end of the study.
  time frame: Throughout the study duration, 12 months post IP administration
  arm group label: 1 dose of AdCLD-CoV19-1 OMI
  arm group type: Experimental
  description: Test group will receive 1 dose of AdCLD-CoV19-1 OMI
  arm group label: 1 dose of Comirnaty Bivalent
  arm group type: Active Comparator
  description: Control group will receive 1 dose of Comirnaty Bivalent
  intervention type: Biological
  intervention name: AdCLD-CoV19-1 OMI
  description: 3000 participants will receive investigational product (AdCLD-CoV19-1 OMI) via intramuscular administration in the deltoid muscle
  arm group label: 1 dose of AdCLD-CoV19-1 OMI
  intervention type: Biological
  intervention name: Comirnaty Bivalent 0.1mg/mL (tozinameran and riltozinameran)
  description: 1000 participants will receive investigational product (Comirnaty Bivalent) via intramuscular administration in the deltoid muscle
  arm group label: 1 dose of Comirnaty Bivalent
  criteria: 
  gender: All
  minimum age: 19 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Wuhyun Kim, D.V.M
  email: whkim@cellid.co.kr
  last name: Hayeon Joo, Bachelor
  email: hyjoo@cellid.co.kr
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  country: Korea, Republic of
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No