<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/NCT04466085</url>
  </required_header>
  <id_info>
    <org_study_id>NCV-Ⅱ-healthy</org_study_id>
    <nct_id>NCT04466085</nct_id>
  </id_info>
  <brief_title>Clinical Study of Recombinant Novel Coronavirus Vaccine</brief_title>
  <official_title>A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Anhui Zhifei Longcom Biologic Pharmacy Co., 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>
      A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose&#xD;
      experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of&#xD;
      placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose&#xD;
      experimental vaccine group and 3 doses of placebo group, the sample size of each group was&#xD;
      150 cases.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose&#xD;
      experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of&#xD;
      placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose&#xD;
      experimental vaccine group and 3 doses of placebo group, the sample size of each group was&#xD;
      150 cases.&#xD;
&#xD;
      Subjects in the 2 dose group were injected with 2 doses of test vaccine or placebo in the&#xD;
      upper arm deltoid muscle according to the 0,1 month immunization program, and subjects in the&#xD;
      3 dose group were injected with 3 doses of test vaccine or placebo in the upper arm deltoid&#xD;
      muscle according to the 0, 1, 2 month immunization program .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">July 12, 2020</start_date>
  <completion_date type="Anticipated">December 15, 2021</completion_date>
  <primary_completion_date type="Actual">October 22, 2020</primary_completion_date>
  <phase>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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neutralizing antibody positive conversion rate</measure>
    <time_frame>30 days after inoculation</time_frame>
    <description>Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neutralizing antibody GMT, positive rate</measure>
    <time_frame>14 days after inoculation</time_frame>
    <description>GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutralizing antibody GMT, positive conversion rate/positive rate</measure>
    <time_frame>14 days after inoculation</time_frame>
    <description>GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutralizing antibody GMT</measure>
    <time_frame>30 days after inoculation</time_frame>
    <description>Neutralizing antibody GMT 30 days after vaccination in pre-negative people</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutralizing antibody GMT</measure>
    <time_frame>6th and 12th month after inoculation</time_frame>
    <description>Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Neutralizing antibody GMI, positive rate</measure>
    <time_frame>6th and 12th month after inoculation</time_frame>
    <description>Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>IL-2, IL-4, IL-5, IL-6 and IFN-γ levels</measure>
    <time_frame>4th day and 12 months after inoculation</time_frame>
    <description>Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Adverse events</measure>
    <time_frame>30 days after inoculation</time_frame>
    <description>Adverse events 30 days after the first dose of vaccine to the entire exemption</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Serious adverse event</measure>
    <time_frame>12 months after inoculation</time_frame>
    <description>Serious adverse events from day 0 after vaccination to 12 months after the entire immunization</description>
  </secondary_outcome>
  <number_of_arms>6</number_of_arms>
  <enrollment type="Actual">900</enrollment>
  <condition>Coronavirus</condition>
  <arm_group>
    <arm_group_label>Population I</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In population I, there were 150 subjects who injected with 2 doses of low-dose test vaccine into the deltoid muscle of the upper arm according to the 0 and 1 month immunization schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population II</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In population II, there were 150 subjects who injected with 2 doses of high-dose test vaccine in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population Ⅲ</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In population Ⅲ, there were 150 subjects who injected with 2 doses of placebo in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population Ⅳ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In population Ⅳ, there were 150 subjects who injected with 3 doses of low-dose test vaccine in the upper arm deltoid muscle according to the 0, 1, and 2 month immunization schedule.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population Ⅴ</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In population Ⅴ, there were 150 subjects who injected with 3 doses of high-dose test vaccine into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Population Ⅵ</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>In Population Ⅵ, there were 150 subjects who injected with 3 doses of placebo into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant new coronavirus vaccine (CHO cell) low-dose group</intervention_name>
    <description>Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).</description>
    <arm_group_label>Population I</arm_group_label>
    <arm_group_label>Population Ⅳ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant new coronavirus vaccine (CHO cells) high-dose group</intervention_name>
    <description>Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).</description>
    <arm_group_label>Population II</arm_group_label>
    <arm_group_label>Population Ⅴ</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Recombinant new coronavirus vaccine (CHO cells) placebo group</intervention_name>
    <description>Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).</description>
    <arm_group_label>Population Ⅲ</arm_group_label>
    <arm_group_label>Population Ⅵ</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Persons with full civil capacity aged 18-59 years (both included);&#xD;
&#xD;
          -  The subjects themselves voluntarily agreed to participate in the study, and signed an&#xD;
             informed consent form, and can provide valid identification; understand and comply&#xD;
             with the requirements of the trial protocol;&#xD;
&#xD;
          -  Body temperature under armpit &lt;37.3℃;&#xD;
&#xD;
          -  Female and male subjects of childbearing age agreed to take effective contraceptive&#xD;
             measures during the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The vital signs and physical examination results of the population specified in the&#xD;
             plan have clinical significance as determined by the clinician;&#xD;
&#xD;
          -  A history of severe allergies to any component of the test vaccine, including aluminum&#xD;
             preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura,&#xD;
             thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, vascular&#xD;
             neuropathy Edema, etc.; or any previous history of serious side effects after using&#xD;
             any vaccine or drug;&#xD;
&#xD;
          -  Those with a history of SARS and SARS-CoV-2 (meet any of the following: ① previous&#xD;
             history of SARS and SARS-CoV-2 infection or morbidity; ② during the current SARS-CoV-2&#xD;
             epidemic, there are patients diagnosed/suspected with the new crown Contact history);&#xD;
&#xD;
          -  Have taken antipyretics or painkillers within 24 hours before the first dose of&#xD;
             vaccination;&#xD;
&#xD;
          -  Within 14 days before the first dose of vaccination, subunit vaccines, inactivated&#xD;
             vaccines, and live attenuated vaccines within 30 days;&#xD;
&#xD;
          -  People with the following diseases: Acute febrile disease; Digestive diseases (eg,&#xD;
             diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; Congenital malformations&#xD;
             or developmental disorders, genetic defects, severe malnutrition, etc.; Congenital or&#xD;
             Acquired immunodeficiency or a history of autoimmune diseases or treatment with&#xD;
             immunomodulators within 6 months, such as hormones; or monoclonal antibodies; or&#xD;
             thymosin; or interferon, etc.; however, topical medications (such as ointment, eye&#xD;
             drops, Inhalation or nasal spray); known to be diagnosed with infectious diseases,&#xD;
             such as: patients with tuberculosis, viral hepatitis and/or human immunodeficiency&#xD;
             virus HIV positive or syphilis specific antibody positive; neurological disease or&#xD;
             Neurodevelopmental dysplasia (eg, migraine, epilepsy, stroke, seizures in the last&#xD;
             three years, encephalopathy, focal neurological deficit, Guillain-Barré syndrome,&#xD;
             encephalomyelitis or transverse myelitis); history of psychiatric illness or family&#xD;
             History; functional spleenlessness, and spleenlessness or splenectomy for any reason;&#xD;
             severe chronic disease or disease in progress that cannot be controlled smoothly, such&#xD;
             as diabetes, thyroid disease; severe liver and kidney disease; respiratory tract that&#xD;
             currently requires daily medication Diseases (eg, chronic obstructive pulmonary&#xD;
             disease [COPD], asthma) or any treatment that exacerbates respiratory diseases (eg,&#xD;
             asthma exacerbations) within the last 5 years; has severe cardiovascular disease (eg,&#xD;
             congestive heart failure, cardiomyopathy, Ischemic heart disease, arrhythmia,&#xD;
             conduction block, myocardial infarction, pulmonary heart disease) or a history of&#xD;
             myocarditis or pericarditis; with thrombocytopenia, any coagulopathy, or treatment&#xD;
             with anticoagulants; tumor patients;&#xD;
&#xD;
          -  Have received blood or blood-related products, including immunoglobulin, within 3&#xD;
             months; or plan to use it during the study;&#xD;
&#xD;
          -  Women who are breastfeeding or pregnant (including a positive urine pregnancy test);&#xD;
&#xD;
          -  Have used any research or unregistered product (medicine, vaccine, biological product&#xD;
             or device) other than the research product within 3 months, or plan to use it during&#xD;
             the research;&#xD;
&#xD;
          -  The researchers believe that any disease or condition in the subject may put the&#xD;
             subject at an unacceptable risk; the subject cannot meet the protocol requirements;&#xD;
             and interfere with the assessment of vaccine response.&#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>
  <location>
    <facility>
      <name>Hunan Provincial Center for Disease Control and Prevention</name>
      <address>
        <city>Hunan</city>
        <state>Changsha</state>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2020</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>December 1, 2020</last_update_submitted>
  <last_update_submitted_qc>December 1, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>NOVID-19</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Coronavirus Infections</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/NCT04466085
org study id: NCV-Ⅱ-healthy
nct id: NCT04466085
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose
      experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of
      placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose
      experimental vaccine group and 3 doses of placebo group, the sample size of each group was
      150 cases.
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose
      experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of
      placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose
      experimental vaccine group and 3 doses of placebo group, the sample size of each group was
      150 cases.

      Subjects in the 2 dose group were injected with 2 doses of test vaccine or placebo in the
      upper arm deltoid muscle according to the 0,1 month immunization program, and subjects in the
      3 dose group were injected with 3 doses of test vaccine or placebo in the upper arm deltoid
      muscle according to the 0, 1, 2 month immunization program .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Prevention
masking: Double (Participant, Investigator)
measure: Neutralizing antibody positive conversion rate
time frame: 30 days after inoculation
description: Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination
measure: Neutralizing antibody GMT, positive rate
time frame: 14 days after inoculation
description: GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people
measure: Neutralizing antibody GMT, positive conversion rate/positive rate
time frame: 14 days after inoculation
description: GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population
measure: Neutralizing antibody GMT
time frame: 30 days after inoculation
description: Neutralizing antibody GMT 30 days after vaccination in pre-negative people
measure: Neutralizing antibody GMT
time frame: 6th and 12th month after inoculation
description: Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination
measure: Neutralizing antibody GMI, positive rate
time frame: 6th and 12th month after inoculation
description: Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination
measure: IL-2, IL-4, IL-5, IL-6 and IFN-γ levels
time frame: 4th day and 12 months after inoculation
description: Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination
measure: Adverse events
time frame: 30 days after inoculation
description: Adverse events 30 days after the first dose of vaccine to the entire exemption
measure: Serious adverse event
time frame: 12 months after inoculation
description: Serious adverse events from day 0 after vaccination to 12 months after the entire immunization
arm group label: Population I
arm group type: Experimental
description: In population I, there were 150 subjects who injected with 2 doses of low-dose test vaccine into the deltoid muscle of the upper arm according to the 0 and 1 month immunization schedule.
arm group label: Population II
arm group type: Experimental
description: In population II, there were 150 subjects who injected with 2 doses of high-dose test vaccine in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule.
arm group label: Population Ⅲ
arm group type: Placebo Comparator
description: In population Ⅲ, there were 150 subjects who injected with 2 doses of placebo in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule.
arm group label: Population Ⅳ
arm group type: Experimental
description: In population Ⅳ, there were 150 subjects who injected with 3 doses of low-dose test vaccine in the upper arm deltoid muscle according to the 0, 1, and 2 month immunization schedule.
arm group label: Population Ⅴ
arm group type: Experimental
description: In population Ⅴ, there were 150 subjects who injected with 3 doses of high-dose test vaccine into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months.
arm group label: Population Ⅵ
arm group type: Placebo Comparator
description: In Population Ⅵ, there were 150 subjects who injected with 3 doses of placebo into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months.
intervention type: Biological
intervention name: Recombinant new coronavirus vaccine (CHO cell) low-dose group
description: Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
arm group label: Population I
arm group label: Population Ⅳ
intervention type: Biological
intervention name: Recombinant new coronavirus vaccine (CHO cells) high-dose group
description: Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
arm group label: Population II
arm group label: Population Ⅴ
intervention type: Biological
intervention name: Recombinant new coronavirus vaccine (CHO cells) placebo group
description: Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
arm group label: Population Ⅲ
arm group label: Population Ⅵ
criteria: 
gender: All
minimum age: 18 Years
maximum age: 59 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: China
responsible party type: Sponsor
mesh term: Coronavirus Infections
mesh term: Vaccines