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/NCT06022224</url>
    </required_header>
    <id_info>
      <org_study_id>COVID-3.001</org_study_id>
      <nct_id>NCT06022224</nct_id>
    </id_info>
    <brief_title>A 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELLVACCINE TRIAL</brief_title>
    <official_title>A Phase 2/3, Placebo-Controlled, Randomized, Observer-Blind Study To Evaluate the Safety, Tolerability, Immunogenicity, and Efficacy of a 2nd Generation E1/E2B/E3-Deleted Adenoviral COVID-19 Vaccine: The TCELLVACCINE TRIAL</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>ImmunityBio, Inc.</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>ImmunityBio, Inc.</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study&#xD;
        assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic&#xD;
        hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects will&#xD;
        be in the &gt;55-year stratum. Safety, immunogenicity, and efficacy assessments will be&#xD;
        conducted per the Schedule of Events (SoE) and subjects are expected to participate for up to&#xD;
        a maximum of approximately 2 years.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">December 9, 2020</start_date>
    <completion_date type="Actual">July 19, 2023</completion_date>
    <primary_completion_date type="Actual">June 23, 2022</primary_completion_date>
    <phase>Phase 2/Phase 3</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Sequential Assignment</intervention_model>
      <intervention_model_description>The first 200 subjects randomized will comprise the phase 2 portion of the study.&#xD;
  Enrollment may continue during this period and these subjects would be included in the phase 3 portion of the study.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Triple (Participant, Care Provider, Investigator)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>COVID-19 incidence based on central laboratory or locally confirmed nucleic acid amplification test (NAAT) in subjects with no serological or virological evidence (up to 14 days after receipt of the last dose) of past SARS-CoV-2 infection</measure>
      <time_frame>14 days after receipt of the last dose</time_frame>
      <description>To evaluate the efficacy of prophylactic hAd5-SFusion+ N-ETSD against confirmed COVID-19 in subjects without serological or virological evidence of infection before vaccination</description>
    </primary_outcome>
    <primary_outcome>
      <measure>COVID-19 incidence based on central laboratory or locally confirmed NAAT in subjects with and without serological or virological evidence of infection before vaccination</measure>
      <time_frame>Before vaccination</time_frame>
      <description>To evaluate the efficacy of prophylactic hAd5-SFusion+ N-ETSD against confirmed COVID-19 in subjects with and without serological or virological evidence of infection before vaccination</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Confirmed NAAT severe COVID-19 incidence in subjects with no serological or virological evidence of past SARS-CoV-2 infection</measure>
      <time_frame>Before vaccination</time_frame>
      <description>To evaluate the efficacy of prophylactic hAd5-SFusion+ N-ETSD against confirmed severe COVID-19 in subjects without serological or virological evidence of infection before vaccination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Confirmed NAAT severe COVID-19 incidence in subjects with and without serological or virological evidence of infection before vaccination</measure>
      <time_frame>Before vaccination</time_frame>
      <description>To evaluate the efficacy of prophylactic hAd5-SFusion+N-ETSD against confirmed severe COVID-19 in subjects with and without serological or virological evidence of infection before vaccination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COVID-19 incidence based on central laboratory or locally confirmed (according to the CDC-defined symptoms) in subjects with no serological or virological evidence (up to 14 days after receipt of the last dose) of past SARS-CoV-2 infection</measure>
      <time_frame>14 days after receipt of the last dose</time_frame>
      <description>To describe the efficacy of prophylactic hAd5-SFusion+N-ETSD against confirmed COVID-19 (according to the CDC defined symptoms) in subjects without serological or virological evidence of infection before vaccination</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>COVID-19 incidence based on central laboratory or locally confirmed (according to the CDC-defined symptoms) in subjects with and without serological or virological evidence of infection before vaccination</measure>
      <time_frame>Before vaccination</time_frame>
      <description>To describe the efficacy of prophylactic hAd5-SFusion+N-ETSD against confirmed COVID-19 (according to the CDCdefined symptoms) in subjects with and without serological or virological evidence of infection before vaccination</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">35</enrollment>
    <condition>COVID-19</condition>
    <arm_group>
      <arm_group_label>hAd5-S-Fusion+N-ETSD</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10^11 VP/dose</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Placebo</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>Prime (SC, Day 1) + Boost (SC, Day 22)</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>hAd5-S-Fusion+N-ETSD</intervention_name>
      <description>Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10^11 viral particles/mL.</description>
      <arm_group_label>hAd5-S-Fusion+N-ETSD</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Placebo (0.9% (w/v) saline)</intervention_name>
      <description>Clear and colorless liquid.</description>
      <arm_group_label>Placebo</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          Subjects are eligible to be included in the study only if all of the following criteria&#xD;
          apply:&#xD;
  &#xD;
          Age and Sex:&#xD;
  &#xD;
            1. Male or female participants ≥16 years of age, at randomization.&#xD;
  &#xD;
               • Refer to Appendix 2 for reproductive criteria for male and female participants.&#xD;
  &#xD;
               Type of Participant and Disease Characteristics:&#xD;
  &#xD;
            2. Participants who are willing and able to comply with all scheduled assessments,&#xD;
               vaccination plan, laboratory tests, lifestyle considerations, and other study&#xD;
               procedures.&#xD;
  &#xD;
            3. Healthy participants who are determined by medical history, physical examination (if&#xD;
               required), and clinical judgment of the investigator to be eligible for inclusion in&#xD;
               the study.&#xD;
  &#xD;
               Note: Healthy participants with preexisting stable disease, defined as disease not&#xD;
               requiring significant change in therapy or hospitalization for worsening disease&#xD;
               during the 6 weeks before enrollment, can be included. Specific criteria for Phase 3&#xD;
               participants with known stable infection with human immunodeficiency virus (HIV),&#xD;
               hepatitis C virus (HCV), or hepatitis B virus (HBV) can be found in Appendix 3.&#xD;
  &#xD;
            4. Participants who, in the judgment of the investigator, are at higher risk for&#xD;
               SARS-CoV-2 infection and subsequent development of COVID-19 (including, but not&#xD;
               limited to, use of mass transportation, relevant demographics, and frontline essential&#xD;
               workers).&#xD;
  &#xD;
               Informed Consent:&#xD;
  &#xD;
            5. Capable of giving personal signed informed consent, which includes compliance with the&#xD;
               requirements and restrictions listed in the informed consent document (ICD) and in&#xD;
               this protocol.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Participants are excluded from the study if any of the following criteria apply:&#xD;
  &#xD;
          Medical Conditions:&#xD;
  &#xD;
            1. Other medical or psychiatric condition including recent (within the past year) or&#xD;
               active suicidal ideation/behavior or laboratory abnormality that may increase the risk&#xD;
               of study participation or, in the investigator's judgment, make the participant&#xD;
               inappropriate for the study.&#xD;
  &#xD;
            2. Phase 2 only: Known infection with human immunodeficiency virus (HIV), hepatitis C&#xD;
               virus (HCV), or hepatitis B virus (HBV).&#xD;
  &#xD;
            3. History of severe adverse reaction associated with a vaccine and/or severe allergic&#xD;
               reaction (eg, anaphylaxis) to any component of the study intervention(s).&#xD;
  &#xD;
            4. Receipt of medications intended to prevent COVID-19.&#xD;
  &#xD;
            5. Previous clinical or microbiological diagnosis of COVID-19.&#xD;
  &#xD;
            6. Immunocompromised individuals with known or suspected immunodeficiency, as determined&#xD;
               by history and/or laboratory/physical examination.&#xD;
  &#xD;
            7. Bleeding diathesis or condition associated with prolonged bleeding that would, in the&#xD;
               opinion of the investigator, contraindicate subcutaneous injection.&#xD;
  &#xD;
            8. Women who are pregnant or breastfeeding.&#xD;
  &#xD;
               Prior/Concomitant Therapy:&#xD;
  &#xD;
            9. Previous vaccination with any coronavirus vaccine.&#xD;
  &#xD;
           10. Individuals who receive treatment with immunosuppressive therapy, including cytotoxic&#xD;
               agents or systemic corticosteroids, eg, for cancer or an autoimmune disease, or&#xD;
               planned receipt throughout the study. If systemic corticosteroids have been&#xD;
               administered short term (&lt;14 days) for treatment of an acute illness, participants&#xD;
               should not be enrolled into the study until corticosteroid therapy has been&#xD;
               discontinued for at least 28 days before study intervention administration.&#xD;
               Inhaled/nebulized, intra-articular, intrabursal, or topical (skin or eyes)&#xD;
               corticosteroids are permitted.&#xD;
  &#xD;
           11. Receipt of blood/plasma products or immunoglobulin, from 60 days before study&#xD;
               intervention administration or planned receipt throughout the study.&#xD;
  &#xD;
               Prior/Concurrent Clinical Study Experience:&#xD;
  &#xD;
           12. Participation in other studies involving study intervention within 28 days prior to&#xD;
               study entry and/or during study participation. Other Exclusions&#xD;
  &#xD;
           13. Investigator site staff or Sponsor employees directly involved in the conduct of the&#xD;
               study, site staff otherwise supervised by the investigator.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>16 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Hoag Memorial Hospital Presbyterian</name>
        <address>
          <city>Newport Beach</city>
          <state>California</state>
          <zip>92663</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>August 30, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 1, 2023</study_first_posted>
    <last_update_submitted>September 1, 2023</last_update_submitted>
    <last_update_submitted_qc>September 1, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 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/NCT06022224
  org study id: COVID-3.001
  nct id: NCT06022224
  lead sponsor: 
  has dmc: No
  is fda regulated drug: Yes
  is fda regulated device: No
  This is a phase 2/3, multicenter, randomized, placebo-controlled, observer-blind study
        assessing the safety, tolerability, immunogenicity, and efficacy of prophylactic
        hAd5-S-Fusion+N-ETSD against COVID-19. It is intended that a minimum of 25% of subjects will
        be in the >55-year stratum. Safety, immunogenicity, and efficacy assessments will be
        conducted per the Schedule of Events (SoE) and subjects are expected to participate for up to
        a maximum of approximately 2 years.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: The first 200 subjects randomized will comprise the phase 2 portion of the study.
  Enrollment may continue during this period and these subjects would be included in the phase 3 portion of the study.
  primary purpose: Treatment
  masking: Triple (Participant, Care Provider, Investigator)
  measure: COVID-19 incidence based on central laboratory or locally confirmed nucleic acid amplification test (NAAT) in subjects with no serological or virological evidence (up to 14 days after receipt of the last dose) of past SARS-CoV-2 infection
  time frame: 14 days after receipt of the last dose
  description: To evaluate the efficacy of prophylactic hAd5-SFusion+ N-ETSD against confirmed COVID-19 in subjects without serological or virological evidence of infection before vaccination
  measure: COVID-19 incidence based on central laboratory or locally confirmed NAAT in subjects with and without serological or virological evidence of infection before vaccination
  time frame: Before vaccination
  description: To evaluate the efficacy of prophylactic hAd5-SFusion+ N-ETSD against confirmed COVID-19 in subjects with and without serological or virological evidence of infection before vaccination
  measure: Confirmed NAAT severe COVID-19 incidence in subjects with no serological or virological evidence of past SARS-CoV-2 infection
  time frame: Before vaccination
  description: To evaluate the efficacy of prophylactic hAd5-SFusion+ N-ETSD against confirmed severe COVID-19 in subjects without serological or virological evidence of infection before vaccination
  measure: Confirmed NAAT severe COVID-19 incidence in subjects with and without serological or virological evidence of infection before vaccination
  time frame: Before vaccination
  description: To evaluate the efficacy of prophylactic hAd5-SFusion+N-ETSD against confirmed severe COVID-19 in subjects with and without serological or virological evidence of infection before vaccination
  measure: COVID-19 incidence based on central laboratory or locally confirmed (according to the CDC-defined symptoms) in subjects with no serological or virological evidence (up to 14 days after receipt of the last dose) of past SARS-CoV-2 infection
  time frame: 14 days after receipt of the last dose
  description: To describe the efficacy of prophylactic hAd5-SFusion+N-ETSD against confirmed COVID-19 (according to the CDC defined symptoms) in subjects without serological or virological evidence of infection before vaccination
  measure: COVID-19 incidence based on central laboratory or locally confirmed (according to the CDC-defined symptoms) in subjects with and without serological or virological evidence of infection before vaccination
  time frame: Before vaccination
  description: To describe the efficacy of prophylactic hAd5-SFusion+N-ETSD against confirmed COVID-19 (according to the CDCdefined symptoms) in subjects with and without serological or virological evidence of infection before vaccination
  arm group label: hAd5-S-Fusion+N-ETSD
  arm group type: Experimental
  description: Prime (SC, Day 1) + Boost (SC, Day 22) @ 1x10^11 VP/dose
  arm group label: Placebo
  arm group type: Placebo Comparator
  description: Prime (SC, Day 1) + Boost (SC, Day 22)
  intervention type: Biological
  intervention name: hAd5-S-Fusion+N-ETSD
  description: Clear and colorless liquid. Each vaccine is supplied in a 2-mL vial containing 1.0 mL of extractable vaccine at a concentration of 1 × 10^11 viral particles/mL.
  arm group label: hAd5-S-Fusion+N-ETSD
  intervention type: Biological
  intervention name: Placebo (0.9% (w/v) saline)
  description: Clear and colorless liquid.
  arm group label: Placebo
  criteria: 
  gender: All
  minimum age: 16 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: COVID-19
  sharing ipd: No