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A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines

Primary Purpose

COVID-19, SARS-CoV-2 Infection

Status
Not yet recruiting
Phase
Phase 2
Locations
Study Type
Interventional
Intervention
SCTV01E-2
SCTV01E
Sponsored by
Sinocelltech Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring SARS-CoV-2, COVID-19, vaccine

Eligibility Criteria

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

Inclusion Criteria: 1. Aged ≥3 years old when signing ICF; 2. Participants who were vaccinated with licenced COVID-19 vaccines with recommended doses and immune schedule, and the interval between the last dose and ICF is ≥6 months. 3. The participant and/or his/her legal guardians or entrusted person can sign the written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial; 4. The participant and/or his/her legal guardians or entrusted person have the ability to read, understand, and fill in record cards; 5. Healthy participants or participants with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment; 6. Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing potential are negative on screening. Exclusion Criteria: 1. Presence of fever within 72 hours before the study vaccination (for participants >14 years old, axillary temperature ≥37.3℃; for participants ≤14 years old, axillary temperature ≥37.5℃;); 2. A positive result of antigen test or nucleic acid test for SARS-CoV-2 during the screening period; 3. A positive result of SARS-CoV-2 IgM test; 4. Known history of SARS-CoV-2 infection within 6 months before ICF; 5. A history of sereve allergic reactions such as severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema, or allergic reactions to the study vaccines and its ingredient; 6. A medical or family history of seizure, epilepsy and psychosis; 7. Participants who is at the acute state of disease, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis; 8. Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders; 9. Patients on antituberculosis therapy; 10. Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination; 11. Participants who received other investigational drugs within 1 month before the study vaccination; 12. Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study; 13. Those who donated blood or had blood loss (≥450 mL) within 3 months before the vaccination or plan to donate blood during the study period; 14. Those who are pregnant or breast-feeding or plan to be pregnant during the study period; 15. Those who plan to donate ovum or sperms during the study period; 16. Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing; 17. Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse the study results, or non-conformance with the maximal benefits of the participants.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Active Comparator

    Experimental

    Arm Label

    Group A:SCTV01E-2

    Group A:SCTV01E

    Group B:SCTV01E-2

    Arm Description

    one dose of SCTV01E-2 on D0

    one dose of SCTV01E on D0

    one dose of SCTV01E-2 on D0

    Outcomes

    Primary Outcome Measures

    Geometric mean titers (GMT) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
    Seroresponse Rate (SRR) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.

    Secondary Outcome Measures

    GMT of neutralizing antibodies against other SARS-CoV-2 variants on D14.
    SRR of neutralizing antibodies against other SARS-CoV-2 variants on D14.
    GMT and SRR of neutralizing antibodies against SARS-CoV-2 variants on D180.
    Incidence and severity of solicited Adverse Events (AEs) of SCTV01E from D0 to D7.
    Incidence and severity of all unsolicited AEs of SCTV01E from D0 to D28.
    Incidence and severity of Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs) of SCTV01E within 365 days.

    Full Information

    First Posted
    July 4, 2023
    Last Updated
    July 4, 2023
    Sponsor
    Sinocelltech Ltd.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05933512
    Brief Title
    A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines
    Official Title
    A Phase II Clinical Trial to Evaluate the Immunogenicity and Safety of SCTV01E-2 (COVID-19 Beta/Omicron (BA.1/BQ.1.1/XBB.1) Variants S-Trimer Vaccine) in Population Previously Vaccinated With mRNA COVID-19 Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    July 2023
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    August 10, 2023 (Anticipated)
    Primary Completion Date
    December 10, 2023 (Anticipated)
    Study Completion Date
    November 10, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Sinocelltech 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
    This study is a phase Ⅱ clinical trial to evaluate the safety and immunogenicity of SCTV01E-2 in people of different ages who had been vaccinated with COVID-19 vaccines. A total of at least 600 subjects aged 3 years and older who were previously vaccinated with domestically licensed SARS-CoV-2 vaccines with recommended doses and immunization schedules are planned to be enrolled. Group A included 400 patients aged 18 years and above, and group B included 200 patients aged 3-17 years.
    Detailed Description
    For participants in Group A, they will be randomized to receive SCTV01E or SCTV01E-2 in a ratio of 1:1. For participants in Group B, they will all receive SCTV01E-2.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19, SARS-CoV-2 Infection
    Keywords
    SARS-CoV-2, COVID-19, vaccine

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 2
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigatorOutcomes Assessor
    Masking Description
    Group A was designed as double-blinded and Group B was open label.
    Allocation
    Randomized
    Enrollment
    600 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Group A:SCTV01E-2
    Arm Type
    Experimental
    Arm Description
    one dose of SCTV01E-2 on D0
    Arm Title
    Group A:SCTV01E
    Arm Type
    Active Comparator
    Arm Description
    one dose of SCTV01E on D0
    Arm Title
    Group B:SCTV01E-2
    Arm Type
    Experimental
    Arm Description
    one dose of SCTV01E-2 on D0
    Intervention Type
    Biological
    Intervention Name(s)
    SCTV01E-2
    Intervention Description
    intramuscular injection
    Intervention Type
    Biological
    Intervention Name(s)
    SCTV01E
    Intervention Description
    intramuscular injection
    Primary Outcome Measure Information:
    Title
    Geometric mean titers (GMT) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
    Time Frame
    day 14 after the study vaccination
    Title
    Seroresponse Rate (SRR) of neutralizing antibodies against SARS-CoV-2 dominant epidemic variant on D14.
    Time Frame
    day 14 after the study vaccination
    Secondary Outcome Measure Information:
    Title
    GMT of neutralizing antibodies against other SARS-CoV-2 variants on D14.
    Time Frame
    Day 14 after the study vaccination
    Title
    SRR of neutralizing antibodies against other SARS-CoV-2 variants on D14.
    Time Frame
    Day 14 after the study vaccination
    Title
    GMT and SRR of neutralizing antibodies against SARS-CoV-2 variants on D180.
    Time Frame
    day 14 after the study vaccination
    Title
    Incidence and severity of solicited Adverse Events (AEs) of SCTV01E from D0 to D7.
    Time Frame
    Day 0 to Day 7 after the study vaccination
    Title
    Incidence and severity of all unsolicited AEs of SCTV01E from D0 to D28.
    Time Frame
    Day 0 to Day 28 after the study vaccination
    Title
    Incidence and severity of Serious Adverse Events (SAEs) and Adverse Event of Special Interests (AESIs) of SCTV01E within 365 days.
    Time Frame
    Day 0 to Day 180 after the study vaccination

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    3 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: 1. Aged ≥3 years old when signing ICF; 2. Participants who were vaccinated with licenced COVID-19 vaccines with recommended doses and immune schedule, and the interval between the last dose and ICF is ≥6 months. 3. The participant and/or his/her legal guardians or entrusted person can sign the written ICF, and can fully understand the trial procedure, the risk of participating in the trial, and other interventions that can be selected if they do not participate in the trial; 4. The participant and/or his/her legal guardians or entrusted person have the ability to read, understand, and fill in record cards; 5. Healthy participants or participants with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or no need for hospitalization as a consequence of worsening disease state for at least 3 months prior to enrollment; 6. Fertile men and women of childbearing potential voluntarily agree to take effective contraceptive measures from signing ICF to 6 months after the study vaccination; the pregnancy test results of women of childbearing potential are negative on screening. Exclusion Criteria: 1. Presence of fever within 72 hours before the study vaccination (for participants >14 years old, axillary temperature ≥37.3℃; for participants ≤14 years old, axillary temperature ≥37.5℃;); 2. A positive result of antigen test or nucleic acid test for SARS-CoV-2 during the screening period; 3. A positive result of SARS-CoV-2 IgM test; 4. Known history of SARS-CoV-2 infection within 6 months before ICF; 5. A history of sereve allergic reactions such as severe skin eczema, dyspnea, laryngeal edema, and angioneurotic edema, or allergic reactions to the study vaccines and its ingredient; 6. A medical or family history of seizure, epilepsy and psychosis; 7. Participants who is at the acute state of disease, such as acute onset of chronic heart failure, acute sore throat, hypertensive encephalopathy, acute pneumonia, acute renal insufficiency, acute cholecystitis; 8. Contraindications for intramuscular injection or intravenous blood sampling, including thrombocytopenia and other blood coagulation disorders; 9. Patients on antituberculosis therapy; 10. Participants vaccinated with influenza vaccine within 14 days or with other vaccines within 28 days before the study vaccination; 11. Participants who received other investigational drugs within 1 month before the study vaccination; 12. Participants who received any immunoglobulin or blood products in the previous 3 months before enrollment, or plan to receive similar products during the study; 13. Those who donated blood or had blood loss (≥450 mL) within 3 months before the vaccination or plan to donate blood during the study period; 14. Those who are pregnant or breast-feeding or plan to be pregnant during the study period; 15. Those who plan to donate ovum or sperms during the study period; 16. Those who cannot follow the trial procedures, or cannot cooperate to complete the study due to planned relocation or long-term outing; 17. Those unsuitable for participating in the clinical trial as determined by the investigator because of other abnormalities that are likely to confuse the study results, or non-conformance with the maximal benefits of the participants.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Xuxin Tian
    Phone
    +86 10 58628288
    Email
    xuxin_tian@sinocelltech.com
    First Name & Middle Initial & Last Name or Official Title & Degree
    Wei Li
    Phone
    +86 10 58628288
    Email
    wei_li@sinocelltech.com

    12. IPD Sharing Statement

    Learn more about this trial

    A Study to Evaluate the Immunogenicity and Safety of A Recombinant Protein COVID-19 Vaccine as Booster Vaccines

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