xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06025812</url>
    </required_header>
    <id_info>
      <org_study_id>LKM-2023-NCV-05</org_study_id>
      <nct_id>NCT06025812</nct_id>
    </id_info>
    <brief_title>Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)</brief_title>
    <official_title>A Randomized, Double-blind, Active-controlled Clinical Study Evaluating the Immunogenicity and Safety of Omicron BA.4/5-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) in People Aged 18 Years and Older With Different Immunization Programs</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>
        Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus&#xD;
        protein vaccine (CHO cells).&#xD;
  &#xD;
        Purpose of the study: Main objectives: To evaluate the immunogenicity and safety of Omicron&#xD;
        BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new&#xD;
        coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses&#xD;
        according to different immunization schedules in people aged 18 years and older. Secondary&#xD;
        purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta recombinant novel&#xD;
        coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and&#xD;
        Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization&#xD;
        schedules in people aged 18 years and older.&#xD;
  &#xD;
        Overall design: Studies were randomized, double-blind, active-controlled study design.&#xD;
  &#xD;
        Study group: There were 160 participants aged 18 years and older, including 80 people aged 60&#xD;
        years and older.&#xD;
  &#xD;
        Study group：Among them, 80 subjects were from the &quot;randomized, double-blind,&#xD;
        active-controlled clinical study to evaluate the immunogenicity and safety of Omicron&#xD;
        BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in people aged&#xD;
        18 years and older, protocol number: LKM-2023-NCV-02&quot;, 40 cases in the study group and 40&#xD;
        cases in the control group, and completed the second dose of vaccine at the 6th month visit&#xD;
        to observe immunogenicity and safety. The remaining 80 subjects were randomly blinded to the&#xD;
        1:1 ratio into the research group and the control group and received 2 doses of the&#xD;
        experimental vaccine according to the 0-1-month procedure to observe immunogenicity and&#xD;
        safety.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 20, 2023</start_date>
    <completion_date type="Anticipated">June 30, 2024</completion_date>
    <primary_completion_date type="Anticipated">May 15, 2024</primary_completion_date>
    <phase>N/A</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>Number of adverse events after 2 doses given intramuscularly according to different immunization programs</measure>
      <time_frame>6 months after 2 doses of vaccine</time_frame>
      <description>The observation of adverse events mainly come from vital sign detection and laboratory examination (including blood routine/urine routine/blood biochemistry/electrocardiogram and chest X-ray), local reactions and systemic reactions after injection.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs</measure>
      <time_frame>14 days after 2 doses of vaccine</time_frame>
      <description>Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Immunogenic end points</measure>
      <time_frame>14 days after 2 doses of vaccine</time_frame>
      <description>Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Laboratory markers of immunity</measure>
      <time_frame>14 days after 2 doses of vaccine</time_frame>
      <description>Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (BA.4/5, BF.7) after 2 doses of vaccine candidate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Laboratory markers of immunity</measure>
      <time_frame>14 days after 2 doses of vaccine</time_frame>
      <description>Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (BA.4/5, BF.7) after 2 doses of investigational vaccine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenic end points</measure>
      <time_frame>14 days after 2 doses of vaccine</time_frame>
      <description>Positive conversion rate against the prototype Omicron variant (BA.4/5, BF.7) after 2 doses of study vaccine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Laboratory markers of immunity</measure>
      <time_frame>14 days after 2 doses of vaccine</time_frame>
      <description>Growth multiple (GMI) of the new coronavirus Omicron variant (XBB) after 2 doses of investigational vaccine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Laboratory markers of immunity</measure>
      <time_frame>6 months after 2 doses of vaccine</time_frame>
      <description>Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (XBB, BA.4/5, BF.7) after 2 doses of vaccine candidate.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Laboratory markers of immunity</measure>
      <time_frame>6 months after 2 doses of vaccine</time_frame>
      <description>Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of investigational vaccine.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Immunogenic end points</measure>
      <time_frame>6 months after 2 doses of vaccine</time_frame>
      <description>Positive conversion rate against the prototype Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of study vaccine.</description>
    </secondary_outcome>
    <number_of_arms>4</number_of_arms>
    <enrollment type="Anticipated">160</enrollment>
    <condition>Coronavirus</condition>
    <arm_group>
      <arm_group_label>0-1-month immune program study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>According to the 0-1-month immunization schedule, two doses of 25 μg/0.5 ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) were injected into the deltoid muscle of the upper arm.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0-1-month immune program control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>According to the 0-1-month immunization schedule, two doses of 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) were injected into the deltoid muscle of the upper arm.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0-6-month immune program study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>The subjects were from the &quot;LKM-2023-NCV-02&quot; project and were vaccinated on a voluntary basis with 25 μg/0.5 ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) at the visit 6 months after the exemption.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>0-6-month immune program control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>The subjects were from the &quot;LKM-2023-NCV-02&quot; project and were vaccinated on a voluntary basis with 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) at the visit 6 months after the exemption.</description>
    </arm_group>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)</intervention_name>
      <description>Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).</description>
      <arm_group_label>0-1-month immune program study group</arm_group_label>
      <arm_group_label>0-6-month immune program study group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Biological</intervention_type>
      <intervention_name>Recombinant novel coronavirus protein vaccine (CHO cells)</intervention_name>
      <description>Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).</description>
      <arm_group_label>0-1-month immune program control group</arm_group_label>
      <arm_group_label>0-6-month immune program control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Be 18 years of age or older at the time of signing the informed consent form.&#xD;
  &#xD;
            2. The subject himself voluntarily participates in the study, signs the informed consent&#xD;
               form, and can provide legal identification, understand and comply with the&#xD;
               requirements of the research protocol.&#xD;
  &#xD;
            3. More than 6 months after completing the basic immunization or booster immunization of&#xD;
               the new coronavirus vaccine.&#xD;
  &#xD;
            4. Female subjects of childbearing age and male subjects who were able to use effective&#xD;
               contraception during the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          Participants were not eligible for study if they had any of the following:&#xD;
  &#xD;
            1. Previous history of severe allergy to any vaccine, or history of severe allergy to any&#xD;
               component of the study vaccine, including aluminum preparations, such as: anaphylactic&#xD;
               shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura,&#xD;
               dyspnea, angioedema, allergic constitution (such as allergy to two or more drugs, food&#xD;
               or pollen), etc.&#xD;
  &#xD;
            2. fever (axillary body temperature≥ 37.3°C) within 72 hours before enrollment, or&#xD;
               axillary body temperature ≥ 37.3°C on the day of enrollment.&#xD;
  &#xD;
            3. Patients infected with the new coronavirus within 3 months before enrollment&#xD;
               (asymptomatic infection or positive nucleic acid or antigen test of the new&#xD;
               coronavirus).&#xD;
  &#xD;
            4. Patients with aplastic anemia that has not been relieved, primary immune&#xD;
               thrombocytopenia (ITP) active period, and uncontrolled coagulation diseases.&#xD;
  &#xD;
            5. history of congenital or acquired immunodeficiency or autoimmune disease; no history&#xD;
               of spleen or spleen surgery or trauma; or receive immunomodulators within 6 months,&#xD;
               such as corticosteroids in immunosuppressant doses (dose reference: equivalent to&#xD;
               prednisone 20 mg/day for more than one week); or monoclonal antibodies; or thymus&#xD;
               peptide; or interferon, etc.; However, topical medications (such as ointments, eye&#xD;
               drops, inhalers, or nasal sprays) are allowed; Lymphoproliferative disorders are not&#xD;
               controlled.&#xD;
  &#xD;
            6. Non-live vaccine ≤ 14 days before vaccination and live attenuated vaccine 30 days&#xD;
               before ≤vaccination.&#xD;
  &#xD;
            7. Patients with malignant tumors who are undergoing chemotherapy, radiotherapy,&#xD;
               immunotherapy, etc. before and after surgery, Patients in the state of organ&#xD;
               transplantation.&#xD;
  &#xD;
            8. Those suffering from uncontrolled epilepsy and other progressive neurological diseases&#xD;
               (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.).&#xD;
  &#xD;
            9. Patients with acute diseases, or acute exacerbations of chronic diseases, or&#xD;
               uncontrolled severe chronic diseases, such as hypertension that cannot be controlled&#xD;
               by drugs (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥100mmHg).&#xD;
  &#xD;
           10. Lactating women or pregnant women; The investigator believes that the participant has&#xD;
               any disease or condition that would put the participant at risk, the participant&#xD;
               cannot complete the study as required by the protocol, and there are circumstances&#xD;
               that interfere with the assessment of vaccine response.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Xie Hai Tang</last_name>
      <phone>0553-5738350</phone>
      <email>xiehaitang@sina.com</email>
    </overall_contact>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Omicron BA.4/5-Delta strain</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>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06025812
  org study id: LKM-2023-NCV-05
  nct id: NCT06025812
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus
        protein vaccine (CHO cells).
  
        Purpose of the study: Main objectives: To evaluate the immunogenicity and safety of Omicron
        BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new
        coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses
        according to different immunization schedules in people aged 18 years and older. Secondary
        purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta recombinant novel
        coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and
        Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization
        schedules in people aged 18 years and older.
  
        Overall design: Studies were randomized, double-blind, active-controlled study design.
  
        Study group: There were 160 participants aged 18 years and older, including 80 people aged 60
        years and older.
  
        Study group：Among them, 80 subjects were from the "randomized, double-blind,
        active-controlled clinical study to evaluate the immunogenicity and safety of Omicron
        BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in people aged
        18 years and older, protocol number: LKM-2023-NCV-02", 40 cases in the study group and 40
        cases in the control group, and completed the second dose of vaccine at the 6th month visit
        to observe immunogenicity and safety. The remaining 80 subjects were randomly blinded to the
        1:1 ratio into the research group and the control group and received 2 doses of the
        experimental vaccine according to the 0-1-month procedure to observe immunogenicity and
        safety.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Prevention
  masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  measure: Number of adverse events after 2 doses given intramuscularly according to different immunization programs
  time frame: 6 months after 2 doses of vaccine
  description: The observation of adverse events mainly come from vital sign detection and laboratory examination (including blood routine/urine routine/blood biochemistry/electrocardiogram and chest X-ray), local reactions and systemic reactions after injection.
  measure: Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs
  time frame: 14 days after 2 doses of vaccine
  description: Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine.
  measure: Immunogenic end points
  time frame: 14 days after 2 doses of vaccine
  description: Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine.
  measure: Laboratory markers of immunity
  time frame: 14 days after 2 doses of vaccine
  description: Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (BA.4/5, BF.7) after 2 doses of vaccine candidate.
  measure: Laboratory markers of immunity
  time frame: 14 days after 2 doses of vaccine
  description: Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (BA.4/5, BF.7) after 2 doses of investigational vaccine.
  measure: Immunogenic end points
  time frame: 14 days after 2 doses of vaccine
  description: Positive conversion rate against the prototype Omicron variant (BA.4/5, BF.7) after 2 doses of study vaccine.
  measure: Laboratory markers of immunity
  time frame: 14 days after 2 doses of vaccine
  description: Growth multiple (GMI) of the new coronavirus Omicron variant (XBB) after 2 doses of investigational vaccine.
  measure: Laboratory markers of immunity
  time frame: 6 months after 2 doses of vaccine
  description: Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (XBB, BA.4/5, BF.7) after 2 doses of vaccine candidate.
  measure: Laboratory markers of immunity
  time frame: 6 months after 2 doses of vaccine
  description: Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of investigational vaccine.
  measure: Immunogenic end points
  time frame: 6 months after 2 doses of vaccine
  description: Positive conversion rate against the prototype Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of study vaccine.
  arm group label: 0-1-month immune program study group
  arm group type: Experimental
  description: According to the 0-1-month immunization schedule, two doses of 25 μg/0.5 ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) were injected into the deltoid muscle of the upper arm.
  arm group label: 0-1-month immune program control group
  arm group type: Active Comparator
  description: According to the 0-1-month immunization schedule, two doses of 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) were injected into the deltoid muscle of the upper arm.
  arm group label: 0-6-month immune program study group
  arm group type: Experimental
  description: The subjects were from the "LKM-2023-NCV-02" project and were vaccinated on a voluntary basis with 25 μg/0.5 ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) at the visit 6 months after the exemption.
  arm group label: 0-6-month immune program control group
  arm group type: Active Comparator
  description: The subjects were from the "LKM-2023-NCV-02" project and were vaccinated on a voluntary basis with 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) at the visit 6 months after the exemption.
  intervention type: Biological
  intervention name: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
  description: Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).
  arm group label: 0-1-month immune program study group
  arm group label: 0-6-month immune program study group
  intervention type: Biological
  intervention name: Recombinant novel coronavirus protein vaccine (CHO cells)
  description: Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).
  arm group label: 0-1-month immune program control group
  arm group label: 0-6-month immune program control group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Xie Hai Tang
  phone: 0553-5738350
  email: xiehaitang@sina.com
  responsible party type: Sponsor
  mesh term: Coronavirus Infections
  mesh term: Vaccines