<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/NCT04405908</url>
  </required_header>
  <id_info>
    <org_study_id>CLO-SCB-2019-001</org_study_id>
    <nct_id>NCT04405908</nct_id>
  </id_info>
  <brief_title>SCB-2019 as COVID-19 Vaccine</brief_title>
  <official_title>A Phase 1, Randomized, Double-blind, Placebo-controlled, First-in-human Study to Evaluate the Safety and Immunogenicity of SCB 2019, a Recombinant SARS-CoV-2 Trimeric S Protein Subunit Vaccine for COVID-19 in Healthy Volunteers.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Clover Biopharmaceuticals AUS Pty Ltd</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Clover Biopharmaceuticals AUS Pty Ltd</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a randomized, double blind, placebo controlled, first-in-human (FIH) study to assess&#xD;
      safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered&#xD;
      as 2 injections IM in healthy subjects. Each study vaccine dose level will be evaluated with&#xD;
      and without adjuvant.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Actual">December 8, 2021</completion_date>
  <primary_completion_date type="Actual">October 20, 2021</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>Sequential Assignment</intervention_model>
    <primary_purpose>Prevention</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Incidence of solicited adverse events (AEs) after vaccination</measure>
    <time_frame>7 days after the first or second vaccination.</time_frame>
    <description>To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of unsolicited AEs after vaccination</measure>
    <time_frame>Day 1 to Day 50</time_frame>
    <description>To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mean change from Baseline in safety laboratory measures (include hematology, coagulation panel, and serum chemistry)</measure>
    <time_frame>Day 1 to Day 50</time_frame>
    <description>To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)</measure>
    <time_frame>Day 1 to Day 184</time_frame>
    <description>To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>As assessed by serum anti-SCB-2019 IgG antibody titers</measure>
    <time_frame>Day 1 to Day 184</time_frame>
    <description>Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity( serum anti SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based) )</measure>
    <time_frame>Day 1 to Day 184</time_frame>
    <description>Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity(serum anti SARS-CoV-2 neutralizing antibody titers (cell based) )</measure>
    <time_frame>Day 1 to Day 184</time_frame>
    <description>Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Immunogenicity(serum anti SARS-CoV-2 whole virus antibody titers)</measure>
    <time_frame>Day 1 to Day 184</time_frame>
    <description>Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Antibody kinetics of each SCB 2019 vaccine formulation after first and second doses</measure>
    <time_frame>Day 1 to Day 184</time_frame>
    <description>Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).</description>
  </secondary_outcome>
  <number_of_arms>27</number_of_arms>
  <enrollment type="Actual">166</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Adult Group 1</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Group 2</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Group 3</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Group 4</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Group 5</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Group 6</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Group 7</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg .</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Group 8</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adult Group 9</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly Group 10</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly Group 11</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly Group 12</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly Group 13</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly Group 14</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Elderly Group 15</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SARS-CoV-2 Seropositive Group 16</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SARS-CoV-2 Seropositive Group 17</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SARS-CoV-2 Seropositive Group 18</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>SARS-CoV-2 Seropositive subjects receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjuvant Dose Modification: Adult Group 19</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjuvant Dose Modification: Adult Group 20</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjuvant Dose Modification: Elderly Group 21</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Adjuvant Dose Modification: Elderly Group 22</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Alum Only Adjuvant Group 23</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Subjects receive SCB-2019 9 µg with Alum adjuvant only.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Phase: Adult Group 24</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Phase: Adult Group 25</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Phase: Elderly Group 26</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Dose Expansion Phase: Elderly Group 27</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SCB-2019</intervention_name>
    <description>SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).</description>
    <arm_group_label>Adult Group 1</arm_group_label>
    <arm_group_label>Adult Group 4</arm_group_label>
    <arm_group_label>Adult Group 7</arm_group_label>
    <arm_group_label>SARS-CoV-2 Seropositive Group 16</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SCB-2019 with AS03 adjuvant</intervention_name>
    <description>SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.</description>
    <arm_group_label>Adjuvant Dose Modification: Adult Group 19</arm_group_label>
    <arm_group_label>Adjuvant Dose Modification: Elderly Group 21</arm_group_label>
    <arm_group_label>Adult Group 2</arm_group_label>
    <arm_group_label>Adult Group 5</arm_group_label>
    <arm_group_label>Adult Group 8</arm_group_label>
    <arm_group_label>Dose Expansion Phase: Adult Group 24</arm_group_label>
    <arm_group_label>Dose Expansion Phase: Elderly Group 26</arm_group_label>
    <arm_group_label>Elderly Group 10</arm_group_label>
    <arm_group_label>Elderly Group 12</arm_group_label>
    <arm_group_label>Elderly Group 14</arm_group_label>
    <arm_group_label>SARS-CoV-2 Seropositive Group 17</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant</intervention_name>
    <description>SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.</description>
    <arm_group_label>Adjuvant Dose Modification: Adult Group 20</arm_group_label>
    <arm_group_label>Adjuvant Dose Modification: Elderly Group 22</arm_group_label>
    <arm_group_label>Adult Group 3</arm_group_label>
    <arm_group_label>Adult Group 6</arm_group_label>
    <arm_group_label>Adult Group 9</arm_group_label>
    <arm_group_label>Dose Expansion Phase: Adult Group 25</arm_group_label>
    <arm_group_label>Dose Expansion Phase: Elderly Group 27</arm_group_label>
    <arm_group_label>Elderly Group 11</arm_group_label>
    <arm_group_label>Elderly Group 13</arm_group_label>
    <arm_group_label>Elderly Group 15</arm_group_label>
    <arm_group_label>SARS-CoV-2 Seropositive Group 18</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>SCB-2019 with Alum adjuvant</intervention_name>
    <description>SCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.</description>
    <arm_group_label>Alum Only Adjuvant Group 23</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Healthy adult male or females, ≥18 years of age at Screening:&#xD;
&#xD;
               1. For the adult group: 18 to 54 years, inclusive, and&#xD;
&#xD;
               2. For the elderly group: 55 to 75 years, inclusive.&#xD;
&#xD;
          2. Individuals who are willing and able to give an informed consent, prior to Screening.&#xD;
&#xD;
          3. Individuals who are able to comply with study requirements.&#xD;
&#xD;
          4. Female subjects are eligible to participate in the study if not pregnant, not&#xD;
             breastfeeding, and at least 1 of the following criteria apply:&#xD;
&#xD;
               1. Women of childbearing potential must have a negative serum pregnancy test at&#xD;
                  Screening and a negative urine pregnancy test prior to each vaccination. They&#xD;
                  must be using a highly effective licensed method of birth control for 30 days&#xD;
                  prior to the first dose of the study vaccine/placebo and must agree to continue&#xD;
                  such precautions during the study until 60 days after the second dose of the&#xD;
                  study vaccine/placebo.&#xD;
&#xD;
               2. Women not of childbearing potential, defined as surgically sterile (documented&#xD;
                  hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or&#xD;
                  postmenopausal (no menses for 12 months and follicle-stimulating hormone [FSH] in&#xD;
                  the postmenopausal range).&#xD;
&#xD;
               3. Male subjects must agree to employ acceptable contraception from the day of first&#xD;
                  dose of the study vaccine/placebo until 90 days after the second dose of the&#xD;
                  study vaccine/placebo and also refrain from donating sperm during this period.&#xD;
&#xD;
          5. General good health based on medical history, physical examination, cardiac health&#xD;
             evaluation, and clinical laboratory evaluations. Participants in the elderly&#xD;
             population who have medically stable, well-controlled co-morbidities may be enrolled&#xD;
             at the discretion of the Investigator.&#xD;
&#xD;
             All clinical laboratory values should be within normal reference ranges unless&#xD;
             confirmed by Investigator or delegate as not clinically significant. One repeat&#xD;
             evaluation of electrocardiogram (ECG), and clinical laboratory tests will be&#xD;
             permitted, at the discretion of the Investigator.&#xD;
&#xD;
          6. Individuals agree to avoid strenuous exercise from Screening to Day 50.&#xD;
&#xD;
             For the SARS-CoV-2 seropositive treatment group only (Treatment Groups 16 to 18):&#xD;
&#xD;
          7. Serological or ELISA confirmation of SARS-CoV-2;&#xD;
&#xD;
          8. No history of severe SARS-CoV-2 symptoms;&#xD;
&#xD;
          9. No SARS-CoV-2 symptoms at the time of the screening .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Individuals with any positive test for SARS-CoV-2 infection, including but not limited&#xD;
             to RT-PCR, at Screening (excluding the SARS-CoV-2 seropositive treatment group&#xD;
             [Treatment Groups 16 to 18]).&#xD;
&#xD;
          2. Individuals with positive serology test results for SARS-CoV-2 at Screening (excluding&#xD;
             the SARS-CoV-2 seropositive treatment group [Treatment Groups 16 to 18]).&#xD;
&#xD;
          3. Individuals with behavioral or cognitive impairment in the opinion of the&#xD;
             Investigator.&#xD;
&#xD;
          4. Individuals with any progressive or severe neurologic disorder, seizure disorder, or&#xD;
             history of Guillian-Barré syndrome.&#xD;
&#xD;
          5. Individuals who are not able to comprehend and to follow all required study procedures&#xD;
             for the whole period of the study.&#xD;
&#xD;
          6. Individuals with known or suspected impairment of the immune system, such as:&#xD;
&#xD;
               1. Use of systemic (oral or parenteral) corticosteroids for ≥14 consecutive days&#xD;
                  within 60 days prior to Day 1. Use of inhaled, intranasal, or topical&#xD;
                  corticosteroids is allowed.Note: Systemic (oral or parenteral) corticosteroids&#xD;
                  are also prohibited for 3 weeks after the second dose of the study&#xD;
                  vaccine/placebo.&#xD;
&#xD;
               2. Receipt of cancer chemotherapy within 5 years prior to Day 1.&#xD;
&#xD;
               3. Receipt of immunostimulants or immunosuppressants within 60 days prior to Day 1.&#xD;
&#xD;
               4. Known HIV or acquired immune deficiency syndrome (AIDS).&#xD;
&#xD;
               5. Subjects with active or prior documented autoimmune disorder (such as potential&#xD;
                  immune-mediated diseases [pIMDs]).&#xD;
&#xD;
               6. Receipt of parenteral immunoglobulin preparation, blood products, and/or plasma&#xD;
                  derivatives within 3 months prior to Day 1 or planned during the full length of&#xD;
                  the study.&#xD;
&#xD;
          7. Positive serology test results for hepatitis C virus antibody, HIV antibody, and/or&#xD;
             hepatitis B virus surface antigen at Screening.&#xD;
&#xD;
          8. Individuals who are pregnant or breastfeeding.&#xD;
&#xD;
          9. Individuals who are allergic to any of the study vaccine/placebo components as&#xD;
             outlined in the current SCB 2019 IB.&#xD;
&#xD;
         10. Individuals who have had a malignancy (excluding nonmelanotic skin cancer) or&#xD;
             lymphoproliferative disorder within the past 5 years from the date of first&#xD;
             administration of the study vaccine/placebo (Day 1).&#xD;
&#xD;
         11. Individuals who have received any other investigational product within 30 days prior&#xD;
             to Day 1 or intent to participate in another clinical study at any time during the&#xD;
             conduct of this study.&#xD;
&#xD;
         12. Individuals with a body temperature ≥38.0 °C (≥100.4 °F) or any acute illness within 3&#xD;
             days of intended study vaccination.&#xD;
&#xD;
         13. Individuals who have a previous confirmed or suspected illness caused by&#xD;
             coronaviruses, SARS-CoV-1, SARS-CoV-2, and Middle East Respiratory Syndrome (MERS)-CoV&#xD;
             (excluding the SARS-CoV-2 seropositive treatment group [Treatment Groups 16 to 18]).&#xD;
&#xD;
         14. Individuals who have received any prior vaccine against a coronavirus, including but&#xD;
             not limited to SARS-CoV, SARS-CoV-2, MERS-CoV.&#xD;
&#xD;
         15. Individuals who have received any other licensed vaccines within 14 days (for&#xD;
             inactivated vaccines) or 28 days (for live vaccines) prior to enrollment in this study&#xD;
             or who are planning to receive any vaccine within 28 days (before or after) the study&#xD;
             vaccine/placebos, with the exception of the seasonal influenza vaccine.&#xD;
&#xD;
         16. Presence of uncontrolled chronic pulmonary, cardiovascular, renal, hepatic,&#xD;
             neurologic, hematologic or metabolic (including diabetes mellitus) disorders, which&#xD;
             would include the potential subject in a high-risk category for SARS CoV 2 infection&#xD;
             and/or its complications.&#xD;
&#xD;
         17. Individuals with known bleeding diathesis.&#xD;
&#xD;
         18. Individuals with a body mass index &lt;18.5 kg/m2 or &gt;35.0 kg/m2.&#xD;
&#xD;
         19. Individuals with a history of drug or alcohol abuse within the past 2 years.&#xD;
&#xD;
         20. Individuals with a history of anaphylaxis or angioedema including but not limited to&#xD;
             history of anaphylaxis after any vaccine.&#xD;
&#xD;
         21. Individuals with any condition that, in the opinion of the Investigator, would&#xD;
             interfere with the primary study objectives or pose additional subject risk.&#xD;
&#xD;
         22. Individuals who are research staff involved with the clinical study or&#xD;
             family/household members of research staff.&#xD;
&#xD;
         23. Individuals must not have donated blood for 2 months prior to Day 1 and must agree to&#xD;
             not donate blood for 6 months post Day 1 (receipt of first dose of study vaccine).&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Linear Clinical Research Ltd</name>
      <address>
        <city>Nedlands</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
  </location_countries>
  <verification_date>February 2022</verification_date>
  <study_first_submitted>May 25, 2020</study_first_submitted>
  <study_first_submitted_qc>May 25, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>February 17, 2022</last_update_submitted>
  <last_update_submitted_qc>February 17, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">February 18, 2022</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Aluminum Hydroxide</mesh_term>
    <mesh_term>Aluminum sulfate</mesh_term>
    <mesh_term>1018 oligonucleotide</mesh_term>
  </intervention_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


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/NCT04405908
org study id: CLO-SCB-2019-001
nct id: NCT04405908
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
This is a randomized, double blind, placebo controlled, first-in-human (FIH) study to assess
      safety, reactogenicity, and immunogenicity of SCB-2019 at multiple dose levels, administered
      as 2 injections IM in healthy subjects. Each study vaccine dose level will be evaluated with
      and without adjuvant.
allocation: Randomized
intervention model: Sequential Assignment
primary purpose: Prevention
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Incidence of solicited adverse events (AEs) after vaccination
time frame: 7 days after the first or second vaccination.
description: To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
measure: Incidence of unsolicited AEs after vaccination
time frame: Day 1 to Day 50
description: To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
measure: Mean change from Baseline in safety laboratory measures (include hematology, coagulation panel, and serum chemistry)
time frame: Day 1 to Day 50
description: To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
measure: Incidence of serious AEs (SAEs) and adverse events of special interest (AESIs)
time frame: Day 1 to Day 184
description: To evaluate the safety and reactogenicity profile of adjuvanted and unadjuvanted SCB-2019 in adult and elderly , when administered as 2 intramuscular doses.
measure: As assessed by serum anti-SCB-2019 IgG antibody titers
time frame: Day 1 to Day 184
description: Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
measure: Immunogenicity( serum anti SARS-CoV-2 neutralizing antibody titers (ACE2 receptor-based) )
time frame: Day 1 to Day 184
description: Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
measure: Immunogenicity(serum anti SARS-CoV-2 neutralizing antibody titers (cell based) )
time frame: Day 1 to Day 184
description: Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
measure: Immunogenicity(serum anti SARS-CoV-2 whole virus antibody titers)
time frame: Day 1 to Day 184
description: Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
measure: Antibody kinetics of each SCB 2019 vaccine formulation after first and second doses
time frame: Day 1 to Day 184
description: Geometric mean titer (GMT). Geometric mean ratio (GMR). Seroconversion rate (SCR).
arm group label: Adult Group 1
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg.
arm group label: Adult Group 2
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.
arm group label: Adult Group 3
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.
arm group label: Adult Group 4
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg .
arm group label: Adult Group 5
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
arm group label: Adult Group 6
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.
arm group label: Adult Group 7
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg .
arm group label: Adult Group 8
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.
arm group label: Adult Group 9
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
arm group label: Elderly Group 10
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with AS03 adjuvant.
arm group label: Elderly Group 11
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 3 µg with CpG 1018 plus Alum adjuvant.
arm group label: Elderly Group 12
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
arm group label: Elderly Group 13
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with CpG 1018 plus Alum adjuvant.
arm group label: Elderly Group 14
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with AS03 adjuvant.
arm group label: Elderly Group 15
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
arm group label: SARS-CoV-2 Seropositive Group 16
arm group type: Placebo Comparator
description: SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg.
arm group label: SARS-CoV-2 Seropositive Group 17
arm group type: Placebo Comparator
description: SARS-CoV-2 Seropositive subjects receive SCB-2019 9 µg with AS03 adjuvant.
arm group label: SARS-CoV-2 Seropositive Group 18
arm group type: Placebo Comparator
description: SARS-CoV-2 Seropositive subjects receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
arm group label: Adjuvant Dose Modification: Adult Group 19
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
arm group label: Adjuvant Dose Modification: Adult Group 20
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
arm group label: Adjuvant Dose Modification: Elderly Group 21
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
arm group label: Adjuvant Dose Modification: Elderly Group 22
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
arm group label: Alum Only Adjuvant Group 23
arm group type: Placebo Comparator
description: Subjects receive SCB-2019 9 µg with Alum adjuvant only.
arm group label: Dose Expansion Phase: Adult Group 24
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
arm group label: Dose Expansion Phase: Adult Group 25
arm group type: Placebo Comparator
description: Adult healthy subjects (18 to 54 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
arm group label: Dose Expansion Phase: Elderly Group 26
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 9 µg with AS03 adjuvant.
arm group label: Dose Expansion Phase: Elderly Group 27
arm group type: Placebo Comparator
description: Elderly healthy subjects (55 to 75 years of age, inclusive) receive SCB-2019 30 µg with CpG 1018 plus Alum adjuvant.
intervention type: Biological
intervention name: SCB-2019
description: SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22).
arm group label: Adult Group 1
arm group label: Adult Group 4
arm group label: Adult Group 7
arm group label: SARS-CoV-2 Seropositive Group 16
intervention type: Biological
intervention name: SCB-2019 with AS03 adjuvant
description: SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with AS03 adjuvant.
arm group label: Adjuvant Dose Modification: Adult Group 19
arm group label: Adjuvant Dose Modification: Elderly Group 21
arm group label: Adult Group 2
arm group label: Adult Group 5
arm group label: Adult Group 8
arm group label: Dose Expansion Phase: Adult Group 24
arm group label: Dose Expansion Phase: Elderly Group 26
arm group label: Elderly Group 10
arm group label: Elderly Group 12
arm group label: Elderly Group 14
arm group label: SARS-CoV-2 Seropositive Group 17
intervention type: Biological
intervention name: SCB-2019 with CpG 1018 adjuvant plus Alum adjuvant
description: SCB-2019 intramuscular vaccinations at 3 µg up to 30 µg twice (on Day 1 and Day 22), and administered with CpG 1018 plus Alum adjuvant.
arm group label: Adjuvant Dose Modification: Adult Group 20
arm group label: Adjuvant Dose Modification: Elderly Group 22
arm group label: Adult Group 3
arm group label: Adult Group 6
arm group label: Adult Group 9
arm group label: Dose Expansion Phase: Adult Group 25
arm group label: Dose Expansion Phase: Elderly Group 27
arm group label: Elderly Group 11
arm group label: Elderly Group 13
arm group label: Elderly Group 15
arm group label: SARS-CoV-2 Seropositive Group 18
intervention type: Biological
intervention name: SCB-2019 with Alum adjuvant
description: SCB-2019 intramuscular vaccinations at 9 µg twice (on Day 1 and Day 22), and administered with Alum adjuvant.
arm group label: Alum Only Adjuvant Group 23
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Australia
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Aluminum Hydroxide
mesh term: Aluminum sulfate
mesh term: 1018 oligonucleotide