<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/NCT04412538</url>
  </required_header>
  <id_info>
    <org_study_id>20200401</org_study_id>
    <nct_id>NCT04412538</nct_id>
  </id_info>
  <brief_title>Safety and Immunogenicity Study of an Inactivated SARS-CoV-2 Vaccine for Preventing Against COVID-19</brief_title>
  <official_title>A Randomized, Double-blind, Placebo-controlled, Phase Ia/IIa Trial of an Inactivated SARS-CoV-2 Vaccine in Healthy People Aged 18 to 59 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>West China Second University Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yunnan Center for Disease Control and Prevention</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</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>
      This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical&#xD;
      trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the&#xD;
      vaccine in healthy people aged 18~59 Years.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This phase Ia/IIa trial is designed to evaluate the safety and immunogenicity of different&#xD;
      doses of the Inactivated SARS-CoV-2 Vaccine inoculated with different immunization schedules&#xD;
      based upon the randomized, double-blind and placebo-controlled principle. A total of 942&#xD;
      subjects aged 18 to 59 years old will be enrolled in the study, of which 192 and 750 will be&#xD;
      enrolled for phase Ia and phase Ⅱa,respectively.The enrolled subjects in phase Ia receive two&#xD;
      doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 14&#xD;
      or 28 days, while the enrolled subjects in Phase Ⅱa receive two doses of medium, high-dose&#xD;
      experimental vaccines or placebo at an interval of 14 or 28 days.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 15, 2020</start_date>
  <completion_date type="Anticipated">September 2021</completion_date>
  <primary_completion_date type="Anticipated">September 2020</primary_completion_date>
  <phase>Phase 1/Phase 2</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>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Adverse reactions/events rate</measure>
    <time_frame>7 days after vaccination</time_frame>
    <description>Occurence of adverse reactions/events after vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse reactions/events rate</measure>
    <time_frame>28 days after vaccination</time_frame>
    <description>Occurence of adverse reactions/events after vaccination</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)</measure>
    <time_frame>14 days after the second vaccination</time_frame>
    <description>Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)</measure>
    <time_frame>14 days after the second vaccination</time_frame>
    <description>Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious adverse events</measure>
    <time_frame>12 months after the second vaccination</time_frame>
    <description>Occurence of Serious adverse events after vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)</measure>
    <time_frame>7, 14 and 28 days after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)</measure>
    <time_frame>14 and 28 days after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)</measure>
    <time_frame>7, 14 and 28 days after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)</measure>
    <time_frame>14 and 28 days after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)</measure>
    <time_frame>14 days after the second vaccination</time_frame>
    <description>Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)</measure>
    <time_frame>14 days after the second vaccination</time_frame>
    <description>Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)</measure>
    <time_frame>7, 14 and 28 days after the second vaccination</time_frame>
    <description>Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)</measure>
    <time_frame>14 and 28 days after the second vaccination</time_frame>
    <description>Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of anti-N protein antibodies Phase Ia (Day 0, 14 schedule)</measure>
    <time_frame>7, 14 and 28 days after the second vaccination</time_frame>
    <description>Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,14</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of anti-N protein antibodies Phase IIa (Day 0, 14 schedule)</measure>
    <time_frame>14 and 28 days after the second vaccination</time_frame>
    <description>Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,14</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of anti-N protein antibodies Phase Ia (Day 0, 28 schedule)</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of anti-N protein antibodies Phase IIa (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,28</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (both schedules)</measure>
    <time_frame>3, 6, 9 and 12 months after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase Ia immunization schedules</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (both schedules)</measure>
    <time_frame>6 and 12 months after the second vaccination</time_frame>
    <description>Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase IIa immunization schedules</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase Ia (both schedules)</measure>
    <time_frame>3, 6, 9 and 12 months after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase Ia immunization schedules</description>
  </other_outcome>
  <other_outcome>
    <measure>Level of IgG antibodies against SARS-CoV-2 Phase IIa (both schedules)</measure>
    <time_frame>6 and 12 months after the second vaccination</time_frame>
    <description>Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase IIa immunization schedules</description>
  </other_outcome>
  <other_outcome>
    <measure>Cellular immune responses Phase Ia (Day 0, 14 schedule)</measure>
    <time_frame>7, 14 and 28 days after the second vaccination</time_frame>
    <description>Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase Ia immunization schedule of day 0,14</description>
  </other_outcome>
  <other_outcome>
    <measure>Cellular immune responses Phase IIa (Day 0, 14 schedule)</measure>
    <time_frame>14 and 28 days after the second vaccination</time_frame>
    <description>Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase IIa immunization schedule of day 0,14</description>
  </other_outcome>
  <other_outcome>
    <measure>Cellular immune responses Phase Ia (Day 0, 28 schedule)</measure>
    <time_frame>7 and 28 days after the second vaccination</time_frame>
    <description>Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase Ia immunization schedule of day 0,28</description>
  </other_outcome>
  <other_outcome>
    <measure>Cellular immune responses Phase IIa (Day 0, 28 schedule)</measure>
    <time_frame>28 days after the second vaccination</time_frame>
    <description>Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase IIa immunization schedule of day 0,28</description>
  </other_outcome>
  <number_of_arms>8</number_of_arms>
  <enrollment type="Anticipated">942</enrollment>
  <condition>COVID-19</condition>
  <arm_group>
    <arm_group_label>Low dosage vaccine on a 0- and 28-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low dosage vaccine on a 0- and 14-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dosage vaccine on a 0- and 28-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Medium dosage vaccine on a 0- and 14-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dosage vaccine on a 0- and 28-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High dosage vaccine on a 0- and 14-day schedule</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo on a 0- and 28-day schedule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two doses of placebo at the vaccination schedule of day 0, 28</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo on a 0- and 14-day schedule</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Two doses of placebo at the vaccination schedule of day 0, 14</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule</intervention_name>
    <description>Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28</description>
    <arm_group_label>Low dosage vaccine on a 0- and 28-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule</intervention_name>
    <description>Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14</description>
    <arm_group_label>Low dosage vaccine on a 0- and 14-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule</intervention_name>
    <description>Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28</description>
    <arm_group_label>Medium dosage vaccine on a 0- and 28-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule</intervention_name>
    <description>Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14</description>
    <arm_group_label>Medium dosage vaccine on a 0- and 14-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule</intervention_name>
    <description>Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28</description>
    <arm_group_label>High dosage vaccine on a 0- and 28-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule</intervention_name>
    <description>Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14</description>
    <arm_group_label>High dosage vaccine on a 0- and 14-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo on a 0- and 28-day schedule</intervention_name>
    <description>Two doses of placebo at the vaccination schedule of day 0,28</description>
    <arm_group_label>Placebo on a 0- and 28-day schedule</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Placebo on a 0- and 14-day schedule</intervention_name>
    <description>Two doses of placebo at the vaccination schedule of day 0,14</description>
    <arm_group_label>Placebo on a 0- and 14-day schedule</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Phase Ia:&#xD;
&#xD;
               1. Healthy adults aged 18 to 59 years (including boundary values), both men and&#xD;
                  women.&#xD;
&#xD;
               2. Proven legal identity.&#xD;
&#xD;
               3. Participants should understand the contents of the informed consent form, the&#xD;
                  vaccine in this trial, voluntarily sign the informed consent form, and be capable&#xD;
                  of using thermometers, scales, and filling in diary cards and contact cards as&#xD;
                  required.&#xD;
&#xD;
               4. Participants should be able to communicate well with investigators, understand&#xD;
                  and comply with the requirements of this trial.&#xD;
&#xD;
               5. Axillary temperature ≤37.0 ℃.&#xD;
&#xD;
          -  Phase IIa:&#xD;
&#xD;
               1. Healthy adults aged 18 to 59 years (including boundary values), both men and&#xD;
                  women.&#xD;
&#xD;
               2. Proven legal identity.&#xD;
&#xD;
               3. Participants should understand the contents of the informed consent form, the&#xD;
                  vaccine in this trial, voluntarily sign the informed consent form, and be capable&#xD;
                  of using thermometers, scales, and filling in diary cards and contact cards as&#xD;
                  required.&#xD;
&#xD;
               4. Participants should be able to communicate well with investigators, understand&#xD;
                  and comply with the requirements of this trial.&#xD;
&#xD;
               5. Axillary temperature ≤37.0 ℃.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Phase Ia:&#xD;
&#xD;
               1. Contraindications for vaccination.&#xD;
&#xD;
               2. History of allergy to vaccines or drugs.&#xD;
&#xD;
               3. Immunization with any vaccine within 1 month.&#xD;
&#xD;
               4. History of abnormal clinical manifestations and serious diseases to be excluded,&#xD;
                  including but not limited to nervous system, cardiovascular system, blood and&#xD;
                  lymphatic system, immune system, kidney, liver, gastrointestinal tract,&#xD;
                  respiratory system, metabolism, bones and other system diseases, and a history of&#xD;
                  malignant tumors.&#xD;
&#xD;
               5. Those who developed acute disease within 2 weeks, or had symptoms of fever or&#xD;
                  upper respiratory tract infection within 7 days.&#xD;
&#xD;
               6. Those who have a hereditary bleeding tendency or coagulation dysfunction, or a&#xD;
                  history of thrombosis or bleeding disorders.&#xD;
&#xD;
               7. Those who cannot tolerate venipuncture, or have a history of halo needles or halo&#xD;
                  blood.&#xD;
&#xD;
               8. Surgical removal of spleen or other important organs for any reason.&#xD;
&#xD;
               9. Those who have undergone surgery within 3 months before signing the informed&#xD;
                  consent, or those who plan to perform surgery during the trial or within 3 months&#xD;
                  after the end of the trial (including cosmetic surgery, dental and oral surgery).&#xD;
&#xD;
              10. Those who donated or lost blood (≥400 mL) in the past 3 months, who received&#xD;
                  blood transfusion or use of blood products, or who planned blood donation during&#xD;
                  the trial.&#xD;
&#xD;
              11. Receipt of other investigational or unregistered products (drugs, vaccines,&#xD;
                  biological product or devices) in the past 3 months, or plan to use other&#xD;
                  investigational or unregistered products during the study.&#xD;
&#xD;
              12. Receipt of immunosuppressive therapy within 6 months before signing the informed&#xD;
                  consent form, such as long-term systemic glucocorticoid therapy (with systemic&#xD;
                  glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone&#xD;
                  or similar drugs) ), but local administration (such as ointment, eye drops,&#xD;
                  inhalation, or nasal spray) is allowed. The local administration should not&#xD;
                  exceed the dosage recommended in the instructions or have any signs of systemic&#xD;
                  exposure.&#xD;
&#xD;
              13. Those who have took soft drugs (such as marijuana) within 3 months before signing&#xD;
                  the informed consent form or took hard drugs (such as: cocaine, phencyclidine,&#xD;
                  etc.) within 1 year before the trial.&#xD;
&#xD;
              14. Those who smoked more than 5 cigarettes per day within 3 months before signing&#xD;
                  the informed consent form.&#xD;
&#xD;
              15. The weekly drinking volume is greater than 14 units within 3 months before&#xD;
                  signing the informed consent form (1 unit alcohol approximately equal to 360 mL&#xD;
                  beer or 45 mL spirits with 40% alcohol content or 150 mL wine).&#xD;
&#xD;
              16. The comprehensive physical examination does not meet the health standards, mainly&#xD;
                  including: (1) Those with abnormal vital signs with clinical significance. (2)&#xD;
                  BMI&lt;18 kg/m^2 or&gt; 30 kg/m^2. (3) Abnormal laboratory examination with clinical&#xD;
                  significance. (4) Those who tested positive for human immunodeficiency virus&#xD;
                  (HIV) antibody, hepatitis B surface antigen, hepatitis B e antigen, hepatitis C&#xD;
                  virus antibody, or Treponema pallidum antibody (tp-trust).&#xD;
&#xD;
              17. Participants who have a positive pregnancy test, or are breastfeeding, or plan to&#xD;
                  become pregnant, or plan to donate sperm or eggs from the screening to 12 months&#xD;
                  after the second vaccination.&#xD;
&#xD;
              18. Positive in drug abuse screening during the screening period (Morphine,&#xD;
                  Methamphetamine, Ketamine, MDMA and Tetrahydrocannabinolic acid).&#xD;
&#xD;
              19. Positive in alcohol breath test during the screening period.&#xD;
&#xD;
              20. Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM)&#xD;
                  screening.&#xD;
&#xD;
              21. History of severe acute respiratory syndrome (SARS) or Middle East respiratory&#xD;
                  syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63,&#xD;
                  HCoV-HKU1).&#xD;
&#xD;
              22. History of contact with confirmed or suspected cases infected with SARS-CoV-2&#xD;
                  within 1 month.&#xD;
&#xD;
              23. Any other situations judged by investigators as not suitable for participating in&#xD;
                  this study.&#xD;
&#xD;
          -  Phase IIa:&#xD;
&#xD;
               1. Contraindications for vaccination.&#xD;
&#xD;
               2. History of allergy to vaccines or drugs.&#xD;
&#xD;
               3. Immunization with any vaccine within 1 month.&#xD;
&#xD;
               4. History of abnormal clinical manifestations and serious diseases to be excluded,&#xD;
                  including but not limited to nervous system, cardiovascular system, blood and&#xD;
                  lymphatic system, immune system, kidney, liver, gastrointestinal tract,&#xD;
                  respiratory system, metabolism, bones and other system diseases, and a history of&#xD;
                  malignant tumors.&#xD;
&#xD;
               5. Those who developed acute disease within 2 weeks, or had symptoms of fever or&#xD;
                  upper respiratory tract infection within 7 days.&#xD;
&#xD;
               6. Those who have a hereditary bleeding tendency or coagulation dysfunction, or a&#xD;
                  history of thrombosis or bleeding disorders.&#xD;
&#xD;
               7. Surgical removal of spleen or other important organs for any reason.&#xD;
&#xD;
               8. Those who have undergone surgery within 3 months before signing the informed&#xD;
                  consent, or those who plan to perform surgery during the trial or within 3 months&#xD;
                  after the end of the trial (including cosmetic surgery, dental and oral surgery).&#xD;
&#xD;
               9. Those who donated or lost blood (≥400 mL) in the past 3 months, who received&#xD;
                  blood transfusion or use of blood products, or who planned blood donation during&#xD;
                  the trial.&#xD;
&#xD;
              10. Receipt of other investigational or unregistered products (drugs, vaccines,&#xD;
                  biological product or devices) in the past 3 months, or plan to use other&#xD;
                  investigational or unregistered products during the study.&#xD;
&#xD;
              11. Receipt of immunosuppressive therapy within 6 months before signing the informed&#xD;
                  consent form, such as long-term systemic glucocorticoid therapy (with systemic&#xD;
                  glucocorticoid therapy for more than 2 weeks within 6 months, such as prednisone&#xD;
                  or similar drugs) ), but local administration (such as ointment, eye drops,&#xD;
                  inhalation, or nasal spray) is allowed. The local administration should not&#xD;
                  exceed the dosage recommended in the instructions or have any signs of systemic&#xD;
                  exposure.&#xD;
&#xD;
              12. The comprehensive physical examination does not meet the health standards, mainly&#xD;
                  including: (1) Those with abnormal vital signs (Pulse &lt;55 beats per minute or&gt;&#xD;
                  100 beats per minute at rest, Systolic blood pressure ≥140mmHg or Diastolic blood&#xD;
                  pressure ≥90mmHg, breathing&gt; 20 beats per minute or &lt;12 beats per minute). (2)&#xD;
                  Those who tested positive for human immunodeficiency virus (HIV) antibody,&#xD;
                  hepatitis B surface antigen, hepatitis B e antigen, hepatitis C virus antibody,&#xD;
                  or Treponema pallidum antibody (tp-trust).&#xD;
&#xD;
              13. Participants who have a positive pregnancy test, or are breastfeeding, or plan to&#xD;
                  become pregnant, or plan to donate sperm or eggs from the screening to 12 months&#xD;
                  after the second vaccination.&#xD;
&#xD;
              14. Positive in SARS-CoV-2 nucleic acid screening or antibodies (IgG or IgM)&#xD;
                  screening.&#xD;
&#xD;
              15. History of severe acute respiratory syndrome (SARS) or Middle East respiratory&#xD;
                  syndrome (MERS) or other coronavirus infection (HCoV-229E, HCoV-OC43, HCoV-NL63,&#xD;
                  HCoV-HKU1).&#xD;
&#xD;
              16. History of contact with confirmed or suspected cases infected with SARS-CoV-2&#xD;
                  within 1 month.&#xD;
&#xD;
              17. Any other situations judged by investigators as not suitable for participating in&#xD;
                  this study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>59 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Qin Yu</last_name>
    <role>Principal Investigator</role>
    <affiliation>West China Second University Hospital</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xiaoqiang Liu</last_name>
    <role>Principal Investigator</role>
    <affiliation>Yunnan Center for Disease Control and Prevention</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Qihan Li, PhD</last_name>
    <phone>86-0871-68335905</phone>
    <email>liqihan@imbcams.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Yanchun Che, Researcher</last_name>
    <phone>86-0871-68335905</phone>
    <email>cheyanchun@imbcams.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>West China Second University Hospital, Sichuan University / West China women's and children's Hospital</name>
      <address>
        <city>Chengdu</city>
        <state>Sichuan</state>
        <zip>610041</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Qin Yu</last_name>
      <phone>86-028-85501952</phone>
      <email>908929936@qq.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>June 1, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 2, 2020</study_first_posted>
  <last_update_submitted>June 2, 2020</last_update_submitted>
  <last_update_submitted_qc>June 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 4, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cancer Institute and Hospital, Chinese Academy of Medical Sciences</investigator_affiliation>
    <investigator_full_name>Qihan Li</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </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>Vaccines</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/NCT04412538
org study id: 20200401
nct id: NCT04412538
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
This study is a randomized, double-blinded, and placebo-controlled phase Ia/IIa clinical
      trial of the Inactivated SARS-CoV-2 Vaccine to evaluate the safety and immunogenicity of the
      vaccine in healthy people aged 18~59 Years.
This phase Ia/IIa trial is designed to evaluate the safety and immunogenicity of different
      doses of the Inactivated SARS-CoV-2 Vaccine inoculated with different immunization schedules
      based upon the randomized, double-blind and placebo-controlled principle. A total of 942
      subjects aged 18 to 59 years old will be enrolled in the study, of which 192 and 750 will be
      enrolled for phase Ia and phase Ⅱa,respectively.The enrolled subjects in phase Ia receive two
      doses of low-, medium-, or high-dose of experimental vaccines or placebo at an interval of 14
      or 28 days, while the enrolled subjects in Phase Ⅱa receive two doses of medium, high-dose
      experimental vaccines or placebo at an interval of 14 or 28 days.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Adverse reactions/events rate
time frame: 7 days after vaccination
description: Occurence of adverse reactions/events after vaccination
measure: Adverse reactions/events rate
time frame: 28 days after vaccination
description: Occurence of adverse reactions/events after vaccination
measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
time frame: 14 days after the second vaccination
description: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
time frame: 14 days after the second vaccination
description: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
measure: Serious adverse events
time frame: 12 months after the second vaccination
description: Occurence of Serious adverse events after vaccination
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
time frame: 7, 14 and 28 days after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
time frame: 14 and 28 days after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,14
measure: Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
time frame: 7, 14 and 28 days after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
measure: Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
time frame: 14 and 28 days after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
time frame: 7 and 28 days after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for the Phase IIa immunization schedule of day 0,28
measure: Level of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
time frame: 7 and 28 days after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
measure: Level of IgG antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
time frame: 14 days after the second vaccination
description: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,14
measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
time frame: 14 days after the second vaccination
description: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
measure: Seroconversion rate of Neutralizing antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Seroconversion rate of neutralizing antibodies against SARS-CoV-2 in serum for the Phase Ia immunization schedule of day 0,28
measure: Seroconversion rate of IgG antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Seroconversion rate of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
measure: Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 14 schedule)
time frame: 7, 14 and 28 days after the second vaccination
description: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,14
measure: Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 14 schedule)
time frame: 14 and 28 days after the second vaccination
description: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,14
measure: Level of anti-N protein antibodies Phase Ia (Day 0, 14 schedule)
time frame: 7, 14 and 28 days after the second vaccination
description: Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,14
measure: Level of anti-N protein antibodies Phase IIa (Day 0, 14 schedule)
time frame: 14 and 28 days after the second vaccination
description: Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,14
measure: Level of IgM antibodies against SARS-CoV-2 Phase Ia (Day 0, 28 schedule)
time frame: 7 and 28 days after the second vaccination
description: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase Ia immunization schedule of day 0,28
measure: Level of IgM antibodies against SARS-CoV-2 Phase IIa (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Level of IgM antibodies against SARS-CoV-2 tested by ELISA in serum for the Phase IIa immunization schedule of day 0,28
measure: Level of anti-N protein antibodies Phase Ia (Day 0, 28 schedule)
time frame: 7 and 28 days after the second vaccination
description: Level of anti-N protein antibodies for the Phase Ia immunization schedule of day 0,28
measure: Level of anti-N protein antibodies Phase IIa (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Level of anti-N protein antibodies for the Phase IIa immunization schedule of day 0,28
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase Ia (both schedules)
time frame: 3, 6, 9 and 12 months after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase Ia immunization schedules
measure: Level of Neutralizing antibodies against SARS-CoV-2 Phase IIa (both schedules)
time frame: 6 and 12 months after the second vaccination
description: Level of neutralizing antibodies against SARS-CoV-2 in serum for both the Phase IIa immunization schedules
measure: Level of IgG antibodies against SARS-CoV-2 Phase Ia (both schedules)
time frame: 3, 6, 9 and 12 months after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase Ia immunization schedules
measure: Level of IgG antibodies against SARS-CoV-2 Phase IIa (both schedules)
time frame: 6 and 12 months after the second vaccination
description: Level of IgG antibodies against SARS-CoV-2 tested by ELISA in serum for both the Phase IIa immunization schedules
measure: Cellular immune responses Phase Ia (Day 0, 14 schedule)
time frame: 7, 14 and 28 days after the second vaccination
description: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase Ia immunization schedule of day 0,14
measure: Cellular immune responses Phase IIa (Day 0, 14 schedule)
time frame: 14 and 28 days after the second vaccination
description: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase IIa immunization schedule of day 0,14
measure: Cellular immune responses Phase Ia (Day 0, 28 schedule)
time frame: 7 and 28 days after the second vaccination
description: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase Ia immunization schedule of day 0,28
measure: Cellular immune responses Phase IIa (Day 0, 28 schedule)
time frame: 28 days after the second vaccination
description: Cellular immune responses (CD4+, CD8+, Th1, Th2, IFN-γ, TNFα, IL-2, IL-6) will be measured for the Phase IIa immunization schedule of day 0,28
arm group label: Low dosage vaccine on a 0- and 28-day schedule
arm group type: Experimental
description: Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
arm group label: Low dosage vaccine on a 0- and 14-day schedule
arm group type: Experimental
description: Two doses of low dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
arm group label: Medium dosage vaccine on a 0- and 28-day schedule
arm group type: Experimental
description: Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
arm group label: Medium dosage vaccine on a 0- and 14-day schedule
arm group type: Experimental
description: Two doses of medium dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
arm group label: High dosage vaccine on a 0- and 28-day schedule
arm group type: Experimental
description: Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 28
arm group label: High dosage vaccine on a 0- and 14-day schedule
arm group type: Experimental
description: Two doses of high dosage Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0, 14
arm group label: Placebo on a 0- and 28-day schedule
arm group type: Placebo Comparator
description: Two doses of placebo at the vaccination schedule of day 0, 28
arm group label: Placebo on a 0- and 14-day schedule
arm group type: Placebo Comparator
description: Two doses of placebo at the vaccination schedule of day 0, 14
intervention type: Biological
intervention name: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
description: Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
arm group label: Low dosage vaccine on a 0- and 28-day schedule
intervention type: Biological
intervention name: Low dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
description: Two doses of low dosage(50U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
arm group label: Low dosage vaccine on a 0- and 14-day schedule
intervention type: Biological
intervention name: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
description: Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
arm group label: Medium dosage vaccine on a 0- and 28-day schedule
intervention type: Biological
intervention name: Medium dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
description: Two doses of medium dosage(100U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
arm group label: Medium dosage vaccine on a 0- and 14-day schedule
intervention type: Biological
intervention name: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 28-day schedule
description: Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,28
arm group label: High dosage vaccine on a 0- and 28-day schedule
intervention type: Biological
intervention name: High dosage Inactivated SARS-CoV-2 Vaccine on a 0- and 14-day schedule
description: Two doses of high dosage(150U/0.5ml) Inactivated SARS-CoV-2 Vaccine at the vaccination schedule of day 0,14
arm group label: High dosage vaccine on a 0- and 14-day schedule
intervention type: Biological
intervention name: Placebo on a 0- and 28-day schedule
description: Two doses of placebo at the vaccination schedule of day 0,28
arm group label: Placebo on a 0- and 28-day schedule
intervention type: Biological
intervention name: Placebo on a 0- and 14-day schedule
description: Two doses of placebo at the vaccination schedule of day 0,14
arm group label: Placebo on a 0- and 14-day schedule
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Qin Yu
role: Principal Investigator
affiliation: West China Second University Hospital
last name: Xiaoqiang Liu
role: Principal Investigator
affiliation: Yunnan Center for Disease Control and Prevention
last name: Qihan Li, PhD
phone: 86-0871-68335905
email: liqihan@imbcams.com
last name: Yanchun Che, Researcher
phone: 86-0871-68335905
email: cheyanchun@imbcams.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Cancer Institute and Hospital, Chinese Academy of Medical Sciences
investigator full name: Qihan Li
investigator title: Professor
mesh term: COVID-19
mesh term: Vaccines