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A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine

Primary Purpose

COVID-19

Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)
Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation
mRNA-based COVID-19 vaccine
Sponsored by
CanSino Biologics Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19

Eligibility Criteria

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

Inclusion Criteria:

  1. Participants aged 18 years and above at the time of screening.
  2. Received the 1st booster vaccination at least 180 days earlier.
  3. Agree to attend all visits and sign the written informed consent form.

Exclusion Criteria:

  1. Have a history of seizures, epilepsy, encephalopathy, psychosis.
  2. History of severe anaphylaxis or allergy to any vaccine component.
  3. Positive urine pregnancy test result, pregnant, lactating women.
  4. Medical history of Guillain-Barré syndrome.
  5. Have had asthma attacks within 2 years.
  6. Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc.
  7. Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder).
  8. Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc.
  9. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate.
  10. Current diagnosis or receiving treatment for tuberculosis or cancer.
  11. History of SARS-CoV-2 infection for less than 3 months.
  12. Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination.
  13. Have an axillary temperature of > 37.0℃.
  14. Any other significant diseases, disorders or findings which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Ad5-nCoV/O group

    Ad5-nCoV/O-IH group

    mRNA-based COVID-19 vaccine group

    Arm Description

    Outcomes

    Primary Outcome Measures

    Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.
    The geometric mean titers (GMT) of anti-Omicron pseudovirus neutralizing antibody on Day 28 post vaccination in all participants

    Secondary Outcome Measures

    Incidence of Adverse Reactions (ARs)
    The incidence of adverse reactions (ARs) within 30 min post vaccination.
    Incidence of Adverse Reactions (ARs)
    The incidence of adverse reactions (ARs) within 14 days post vaccination
    The incidence of AR and AE
    The incidence of ARs/adverse events (AEs) within 28 days post vaccination.
    Incidence of SAE
    The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post vaccination.
    Immunogenicity of pseudovirus neutralizing antibody
    The GMT, geometric mean increase fold (GMI) and sero-conversion rate (SCR) of anti-Omicron pseudovirus neutralizing antibody on Day 14 and Day 28 post-vaccination in all participants.
    Immunogenicity of S-RBD IgG antibody
    The geometric mean concentration (GMC), GMI and SCR of anti-Omicron S-RBD IgG antibody on Day 14 and Day 28 post-vaccination in all participants.
    Immunogenicity of S-RBD serum IgA antibody
    The GMT, GMI, and SCR of anti-Omicron S-RBD serum IgA antibody on Day 14 and Day 28 post-vaccination in all participants.
    Immunogenicity of pseudovirus neutralizing antibody
    The GMT, GMI and SCR of anti-Omicron pseudovirus neutralizing antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.
    Immunogenicity of S-RBD IgG antibody
    The GMC, GMI and SCR of anti-Omicron S-RBD IgG antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.
    Immunogenicity of S-RBD serum IgA antibody
    The GMC, GMI and SCR of anti-Omicron S-RBD serum IgA antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup
    Virological confirmed COVID-19 cases
    The number of virological confirmed COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
    Virological confirmed severe COVID-19 cases.
    The number of virological confirmed severe COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
    Virological confirmed asymptomatic COVID-19 cases
    The number of virological confirmed asymptomatic COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
    Immunogenicity of anti-Nucleocapsid antibody
    The GMT of anti-Nucleocapsid antibody before vaccination
    Immunogenicity of saliva secretory IgA (SIgA)
    The GMC, GMI, and SCR of saliva secretory IgA (SIgA) on Day 14 and Day 28 post-vaccination in participants of the immunogenicity subgroup.
    The level and positive rate of interferon γ (IFN-γ)
    The level and positive rate of interferon γ (IFN-γ) on Day 14 and Day 28 after the 2nd booster dose.
    The neutralizing antibody against other VOCs or emerging variant(s).
    The neutralizing antibody on Day 28 against VOCs or other emerging variants.

    Full Information

    First Posted
    June 16, 2022
    Last Updated
    June 14, 2023
    Sponsor
    CanSino Biologics Inc.
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05442684
    Brief Title
    A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine
    Official Title
    A Multicenter, Randomized, and Observer-blind Clinical Trial to Evaluate the Safety and Immunogenicity of Ad5-based COVID-19 Vaccine Against Coronavirus Variants in Adults (≥ 18 Years) Who Have Been Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    October 2022
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    The trial protocol was not approved by the regulatory authorities.
    Study Start Date
    November 30, 2022 (Anticipated)
    Primary Completion Date
    March 30, 2023 (Anticipated)
    Study Completion Date
    June 30, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    CanSino Biologics Inc.

    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
    Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.
    Detailed Description
    This is a multicenter, randomized, observer-blind, and parallel-controlled clinical study to evaluate the immune responses and safety profiles in adults (≥ 18 years) receiving investigational products (intramuscular injection or nebulized inhalation) ≥ 180 days after the immunization of 2 doses of BNT162b2 vaccines plus one dose of booster AZD1222 vaccine. This study will enroll about 30% participants aged 60 years and above. Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    COVID-19

    7. Study Design

    Primary Purpose
    Prevention
    Study Phase
    Phase 3
    Interventional Study Model
    Parallel Assignment
    Model Description
    Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O, Ad5-nCoV/O-IH or mRNA-based COVID-19 vaccine in a ratio of 2:2:1.
    Masking
    Investigator
    Masking Description
    observer-blind clinical trial
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ad5-nCoV/O group
    Arm Type
    Experimental
    Arm Title
    Ad5-nCoV/O-IH group
    Arm Type
    Experimental
    Arm Title
    mRNA-based COVID-19 vaccine group
    Arm Type
    Active Comparator
    Intervention Type
    Biological
    Intervention Name(s)
    Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector)
    Intervention Description
    Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O
    Intervention Type
    Biological
    Intervention Name(s)
    Bivalent Recombinant COVID-19 Vaccine (Adenovirus Type 5 Vector) for Inhalation
    Intervention Description
    Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of Ad5-nCoV/O-IH
    Intervention Type
    Biological
    Intervention Name(s)
    mRNA-based COVID-19 vaccine
    Intervention Description
    Subjects who have completed the primary mRNA vaccine immunizations and the 1st booster AZD1222 immunization for more than 6 months will be randomized to receive a 2nd booster dose of mRNA-based COVID-19 vaccine
    Primary Outcome Measure Information:
    Title
    Immunogenicity of Ad5-nCoV/O or Ad5-nCoV/O-IH versus BNT162b2 as the 2nd booster dose.
    Description
    The geometric mean titers (GMT) of anti-Omicron pseudovirus neutralizing antibody on Day 28 post vaccination in all participants
    Time Frame
    Day 28 post vaccination
    Secondary Outcome Measure Information:
    Title
    Incidence of Adverse Reactions (ARs)
    Description
    The incidence of adverse reactions (ARs) within 30 min post vaccination.
    Time Frame
    within 30 min post vaccination
    Title
    Incidence of Adverse Reactions (ARs)
    Description
    The incidence of adverse reactions (ARs) within 14 days post vaccination
    Time Frame
    within 14 days post vaccination
    Title
    The incidence of AR and AE
    Description
    The incidence of ARs/adverse events (AEs) within 28 days post vaccination.
    Time Frame
    within 28 days post vaccination
    Title
    Incidence of SAE
    Description
    The incidence of serious adverse events (SAEs) and adverse events of special interest (AESIs) within 12 months post vaccination.
    Time Frame
    within 12 months post vaccination
    Title
    Immunogenicity of pseudovirus neutralizing antibody
    Description
    The GMT, geometric mean increase fold (GMI) and sero-conversion rate (SCR) of anti-Omicron pseudovirus neutralizing antibody on Day 14 and Day 28 post-vaccination in all participants.
    Time Frame
    on Day 14 and Day 28 post-vaccination
    Title
    Immunogenicity of S-RBD IgG antibody
    Description
    The geometric mean concentration (GMC), GMI and SCR of anti-Omicron S-RBD IgG antibody on Day 14 and Day 28 post-vaccination in all participants.
    Time Frame
    on Day 14 and Day 28 post-vaccination
    Title
    Immunogenicity of S-RBD serum IgA antibody
    Description
    The GMT, GMI, and SCR of anti-Omicron S-RBD serum IgA antibody on Day 14 and Day 28 post-vaccination in all participants.
    Time Frame
    on Day 14 and Day 28 post-vaccination
    Title
    Immunogenicity of pseudovirus neutralizing antibody
    Description
    The GMT, GMI and SCR of anti-Omicron pseudovirus neutralizing antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.
    Time Frame
    on Month 3, Month 6, and Month 12 post-vaccination
    Title
    Immunogenicity of S-RBD IgG antibody
    Description
    The GMC, GMI and SCR of anti-Omicron S-RBD IgG antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup.
    Time Frame
    on Month 3, Month 6, and Month 12 post-vaccination
    Title
    Immunogenicity of S-RBD serum IgA antibody
    Description
    The GMC, GMI and SCR of anti-Omicron S-RBD serum IgA antibody on Month 3, Month 6, and Month 12 post-vaccination in participants of the immunogenicity subgroup
    Time Frame
    on Month 3, Month 6, and Month 12 post-vaccination
    Title
    Virological confirmed COVID-19 cases
    Description
    The number of virological confirmed COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
    Time Frame
    from Day 14 post-vaccination
    Title
    Virological confirmed severe COVID-19 cases.
    Description
    The number of virological confirmed severe COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
    Time Frame
    from Day 14 post-vaccination
    Title
    Virological confirmed asymptomatic COVID-19 cases
    Description
    The number of virological confirmed asymptomatic COVID-19 cases occurring from Day 14 post-vaccination in different vaccine groups.
    Time Frame
    from Day 14 post-vaccination
    Title
    Immunogenicity of anti-Nucleocapsid antibody
    Description
    The GMT of anti-Nucleocapsid antibody before vaccination
    Time Frame
    before vaccination
    Title
    Immunogenicity of saliva secretory IgA (SIgA)
    Description
    The GMC, GMI, and SCR of saliva secretory IgA (SIgA) on Day 14 and Day 28 post-vaccination in participants of the immunogenicity subgroup.
    Time Frame
    on Day 14 and Day 28 post-vaccination
    Title
    The level and positive rate of interferon γ (IFN-γ)
    Description
    The level and positive rate of interferon γ (IFN-γ) on Day 14 and Day 28 after the 2nd booster dose.
    Time Frame
    on Day 14 and Day 28 after the 2nd booster dose
    Title
    The neutralizing antibody against other VOCs or emerging variant(s).
    Description
    The neutralizing antibody on Day 28 against VOCs or other emerging variants.
    Time Frame
    on Day 28

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participants aged 18 years and above at the time of screening. Received the 1st booster vaccination at least 180 days earlier. Agree to attend all visits and sign the written informed consent form. Exclusion Criteria: Have a history of seizures, epilepsy, encephalopathy, psychosis. History of severe anaphylaxis or allergy to any vaccine component. Positive urine pregnancy test result, pregnant, lactating women. Medical history of Guillain-Barré syndrome. Have had asthma attacks within 2 years. Have severe nasal or oral diseases, such as rhinitis (sinusitis), allergic rhinitis, oral ulcer, throat swelling, etc. Bleeding disorder (e.g. protein S or factor deficiency, coagulopathy or platelet disorder). Have chronic systematic infection or chronic obstructive pulmonary disease (COPD), etc. Administration of immunoglobulins and/or any blood products within three months prior to the planned administration of the vaccine candidate. Current diagnosis or receiving treatment for tuberculosis or cancer. History of SARS-CoV-2 infection for less than 3 months. Received or plan to receive any vaccines (licensed or investigational), within 14 days before and after study vaccination. Have an axillary temperature of > 37.0℃. Any other significant diseases, disorders or findings which may significantly increase the risk to the volunteer because of participation in the study, and affect the ability of the volunteer to participate in the study or impair interpretation of the study data.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    A Study to Evaluate the Safety and Immunogenicity of Ad5-vector Based Vaccine Against Coronavirus Variants in Adults (≥18 Years) Immunized With 2 Doses of mRNA Vaccines Plus One Dose of Booster AZD1222 Vaccine

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