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Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)

Primary Purpose

Coronavirus

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
Recombinant novel coronavirus protein vaccine (CHO cells)
Sponsored by
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Coronavirus focused on measuring Omicron BA.4/5-Delta strain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Be 18 years of age or older at the time of signing the informed consent form. The subject himself voluntarily participates in the study, signs the informed consent form, and can provide legal identification, understand and comply with the requirements of the research protocol. More than 6 months after completing the basic immunization or booster immunization of the new coronavirus vaccine. Female subjects of childbearing age and male subjects who were able to use effective contraception during the study. Exclusion Criteria: Participants were not eligible for study if they had any of the following: Previous history of severe allergy to any vaccine, or history of severe allergy to any component of the study vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, dyspnea, angioedema, allergic constitution (such as allergy to two or more drugs, food or pollen), etc. fever (axillary body temperature≥ 37.3°C) within 72 hours before enrollment, or axillary body temperature ≥ 37.3°C on the day of enrollment. Patients infected with the new coronavirus within 3 months before enrollment (asymptomatic infection or positive nucleic acid or antigen test of the new coronavirus). Patients with aplastic anemia that has not been relieved, primary immune thrombocytopenia (ITP) active period, and uncontrolled coagulation diseases. history of congenital or acquired immunodeficiency or autoimmune disease; no history of spleen or spleen surgery or trauma; or receive immunomodulators within 6 months, such as corticosteroids in immunosuppressant doses (dose reference: equivalent to prednisone 20 mg/day for more than one week); or monoclonal antibodies; or thymus peptide; or interferon, etc.; However, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are allowed; Lymphoproliferative disorders are not controlled. Non-live vaccine ≤ 14 days before vaccination and live attenuated vaccine 30 days before ≤vaccination. Patients with malignant tumors who are undergoing chemotherapy, radiotherapy, immunotherapy, etc. before and after surgery, Patients in the state of organ transplantation. Those suffering from uncontrolled epilepsy and other progressive neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.). Patients with acute diseases, or acute exacerbations of chronic diseases, or uncontrolled severe chronic diseases, such as hypertension that cannot be controlled by drugs (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥100mmHg). Lactating women or pregnant women; The investigator believes that the participant has any disease or condition that would put the participant at risk, the participant cannot complete the study as required by the protocol, and there are circumstances that interfere with the assessment of vaccine response.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Active Comparator

    Arm Label

    0-1-month immune program study group

    0-1-month immune program control group

    0-6-month immune program study group

    0-6-month immune program control group

    Arm 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.

    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.

    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.

    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.

    Outcomes

    Primary Outcome Measures

    Number of adverse events after 2 doses given intramuscularly according to different immunization programs
    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.
    Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs
    Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine.
    Immunogenic end points
    Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine.

    Secondary Outcome Measures

    Laboratory markers of immunity
    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.
    Laboratory markers of immunity
    Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (BA.4/5, BF.7) after 2 doses of investigational vaccine.
    Immunogenic end points
    Positive conversion rate against the prototype Omicron variant (BA.4/5, BF.7) after 2 doses of study vaccine.
    Laboratory markers of immunity
    Growth multiple (GMI) of the new coronavirus Omicron variant (XBB) after 2 doses of investigational vaccine.
    Laboratory markers of immunity
    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.
    Laboratory markers of immunity
    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.
    Immunogenic end points
    Positive conversion rate against the prototype Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of study vaccine.

    Full Information

    First Posted
    August 30, 2023
    Last Updated
    September 5, 2023
    Sponsor
    Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT06025812
    Brief Title
    Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)
    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
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    September 20, 2023 (Anticipated)
    Primary Completion Date
    May 15, 2024 (Anticipated)
    Study Completion Date
    June 30, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Coronavirus
    Keywords
    Omicron BA.4/5-Delta strain

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    160 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    0-1-month immune program study group
    Arm Type
    Experimental
    Arm 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 Title
    0-1-month immune program control group
    Arm Type
    Active Comparator
    Arm 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 Title
    0-6-month immune program study group
    Arm Type
    Experimental
    Arm 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 Title
    0-6-month immune program control group
    Arm Type
    Active Comparator
    Arm 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(s)
    Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
    Intervention 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).
    Intervention Type
    Biological
    Intervention Name(s)
    Recombinant novel coronavirus protein vaccine (CHO cells)
    Intervention Description
    Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).
    Primary Outcome Measure Information:
    Title
    Number of adverse events after 2 doses given intramuscularly according to different immunization programs
    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.
    Time Frame
    6 months after 2 doses of vaccine
    Title
    Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs
    Description
    Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine.
    Time Frame
    14 days after 2 doses of vaccine
    Title
    Immunogenic end points
    Description
    Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine.
    Time Frame
    14 days after 2 doses of vaccine
    Secondary Outcome Measure Information:
    Title
    Laboratory markers of immunity
    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.
    Time Frame
    14 days after 2 doses of vaccine
    Title
    Laboratory markers of immunity
    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.
    Time Frame
    14 days after 2 doses of vaccine
    Title
    Immunogenic end points
    Description
    Positive conversion rate against the prototype Omicron variant (BA.4/5, BF.7) after 2 doses of study vaccine.
    Time Frame
    14 days after 2 doses of vaccine
    Title
    Laboratory markers of immunity
    Description
    Growth multiple (GMI) of the new coronavirus Omicron variant (XBB) after 2 doses of investigational vaccine.
    Time Frame
    14 days after 2 doses of vaccine
    Title
    Laboratory markers of immunity
    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.
    Time Frame
    6 months after 2 doses of vaccine
    Title
    Laboratory markers of immunity
    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.
    Time Frame
    6 months after 2 doses of vaccine
    Title
    Immunogenic end points
    Description
    Positive conversion rate against the prototype Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of study vaccine.
    Time Frame
    6 months after 2 doses of vaccine

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Be 18 years of age or older at the time of signing the informed consent form. The subject himself voluntarily participates in the study, signs the informed consent form, and can provide legal identification, understand and comply with the requirements of the research protocol. More than 6 months after completing the basic immunization or booster immunization of the new coronavirus vaccine. Female subjects of childbearing age and male subjects who were able to use effective contraception during the study. Exclusion Criteria: Participants were not eligible for study if they had any of the following: Previous history of severe allergy to any vaccine, or history of severe allergy to any component of the study vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, dyspnea, angioedema, allergic constitution (such as allergy to two or more drugs, food or pollen), etc. fever (axillary body temperature≥ 37.3°C) within 72 hours before enrollment, or axillary body temperature ≥ 37.3°C on the day of enrollment. Patients infected with the new coronavirus within 3 months before enrollment (asymptomatic infection or positive nucleic acid or antigen test of the new coronavirus). Patients with aplastic anemia that has not been relieved, primary immune thrombocytopenia (ITP) active period, and uncontrolled coagulation diseases. history of congenital or acquired immunodeficiency or autoimmune disease; no history of spleen or spleen surgery or trauma; or receive immunomodulators within 6 months, such as corticosteroids in immunosuppressant doses (dose reference: equivalent to prednisone 20 mg/day for more than one week); or monoclonal antibodies; or thymus peptide; or interferon, etc.; However, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are allowed; Lymphoproliferative disorders are not controlled. Non-live vaccine ≤ 14 days before vaccination and live attenuated vaccine 30 days before ≤vaccination. Patients with malignant tumors who are undergoing chemotherapy, radiotherapy, immunotherapy, etc. before and after surgery, Patients in the state of organ transplantation. Those suffering from uncontrolled epilepsy and other progressive neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.). Patients with acute diseases, or acute exacerbations of chronic diseases, or uncontrolled severe chronic diseases, such as hypertension that cannot be controlled by drugs (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥100mmHg). Lactating women or pregnant women; The investigator believes that the participant has any disease or condition that would put the participant at risk, the participant cannot complete the study as required by the protocol, and there are circumstances that interfere with the assessment of vaccine response.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xie Hai Tang
    Phone
    0553-5738350
    Email
    xiehaitang@sina.com

    12. IPD Sharing Statement

    Learn more about this trial

    Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)

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