Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of BBIBP-CorV

NCT05205083
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Phase
Phase 1/Phase 2
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Recruitment status
Unknown
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Participants
480
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Lead sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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Start date
2021-11-10
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Number of sites
1
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Summary
Study objectives: To evaluate the immunogenicity and immunity persistence and safety of recombinant novel coronavirus vaccine (CHO cells) after booster immunization in populations vaccinated with two doses of marketed novel coronavirus inactivated vaccine (BBIBP-CorV). Study method: For the subjects who have been vaccinated with two doses (the interval between two doses ≥ 3 weeks) of the novel coronavirus inactivated vaccine (BBIBP-CorV) for 3 to 9 months, 1 dose of the recombinant novel coronavirus vaccine (CHO cells) was administered. Blood samples were collected before booster immunization, 14 days, 30 days and 180 days after booster immunization for neutralizing antibody detection. All AEs were collected within 1 month after the booster immunization. All SAEs were collected within 6 months after the booster immunization.
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Short title
Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of BBIBP-CorV
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Official title
Study on the Immunogenicity and Safety of Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) After Inoculation With Two Doses of Inactivated Vaccine (BBIBP-CorV) in People Over 18 Years Old
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Control arm
Open label
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Registry reports results
No
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Listing at source
Listed
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Recruitment status
Unknown
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Phase
Phase 1/Phase 2
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Study type
Interventional
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Completion date
2022-07-01
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First posted
2022-01-24
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Registry last updated
2022-01-24
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Primary completion date
2022-03-01
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Start date
2021-11-10
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Participants
480
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Participant count basis
Estimated
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Planned participants
480
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Protocol amendments
0
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Number of sites
1
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Data monitoring committee
No
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Registry sponsor category
Industry
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Lead sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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Source registry
ClinicalTrials.gov
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Registry ID
NCT05205083
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ClinicalTrials.gov ID
NCT05205083
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Registry record
Open registry record
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Allocation
Not applicable
Model
Single group
Purpose
Prevention
Masking
No masking
Sources for study design
clinicaltrials.gov

  1. Immunogenicity endpoint

    Timeframe: 14 days after booster vaccination

    Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody

  1. Immunogenicity endpoint

    Timeframe: 30, 180 days after booster vaccination

    Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody

  2. Immunogenicity endpoint

    Timeframe: 14 days, 30 days, and 180 days after booster vaccination

    4 times growth rate of SARS-CoV-2 neutralizing antibody

  3. Safety endpoint

    Timeframe: Within 1 month after booster vaccination

    Incidence of AEs

  4. Safety endpoint

    Timeframe: Within 6 months after booster vaccination

    Incidence of SAEs

Sources for outcomes
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Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
Yes

  • Healthy subjects over 18 years old, and can provide vaccination information to prove that they have completed 2 doses of inactivated novel coronavirus vaccine (BBIBP-CorV) within the past 3-9 months;
  • The subjects voluntarily participate in the research, sign the informed consent form, and can provide valid identification, understand and comply with the requirements of the study protocol;
  • Female subjects of childbearing age agree to use effective contraception from the start of the study to 2 months after vaccination.

  • Suspected or confirmed fever (fever ≥38.5℃) within 72 hours before enrollment, or axillary body temperature ≥37.3℃ on the day of enrollment;
  • Diastolic blood pressure ≥ 100 mmHg and/or systolic blood pressure ≥ 160 mmHg without or after drug control;
  • Have a history of previous infection with new coronary pneumonia or a positive nucleic acid test history;
  • Those who currently suffer from the following diseases: 1.Thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy, etc.; 2.History of congenital or acquired immunodeficiency or autoimmune disease; asplenia, or history of spleen surgery, trauma, or treatment with immunomodulatory agents within 6 months, such as: immunosuppressive doses of glucocorticoids (dose reference: equivalent or prednisone 20mg/day for more than one week); or monoclonal antibody; or thymosin; or interferon, etc.; 3.Those suffering from acute infectious diseases or using antipyretic/analgesic/antiallergic drugs within 3 days before enrollment, or acute exacerbation of chronic diseases; 4.Cancer patients (except basal cell carcinoma) who have been off treatment for less than 6 months; 5.Serious chronic diseases such as congenital heart disease, severe liver and kidney disease, severe diabetes (with complications) that may interfere with the conduct or completion of the study; 6.Active tuberculosis, viral hepatitis patients with obvious liver damage (excluding virus carriers) and/or HIV-positive or syphilis-specific antibody-positive;
  • Previous history of severe hypersensitivity to any vaccine, or severe hypersensitivity history to any component of the investigational vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, anaphylactoid purpura, thrombocytopenic purpura, dyspnea, vascular nerve edema, etc.;
  • Administer subunit vaccine and inactivated vaccine within 14 days before the trial vaccine, and receive live attenuated vaccine within 28 days;
  • Received blood or blood-related products, including immune globulin, within 3 months prior to screening; or planned use within 6 months after study initiation to full vaccination;
  • In addition to completing 2 doses of inactivated novel coronavirus vaccine within the past 3-9 months, participating in other COVID-19 related clinical trials;
  • Pregnant women (including women of childbearing age with positive urine pregnancy test);
  • Investigators believe that the presence of any disease or condition in the subject may put the subject at unacceptable risk; the subject cannot meet protocol requirements; interfere with the assessment of vaccine response, etc.
Sources for eligibility
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  • Zhejiang Provincial Center for Disease Control and PreventionHangzhou, ChinaRecruiting
Sources for sites
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Sources for references
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Related records

Drugs (1)

Collaborators (1)

Lead sponsors (1)

Conditions (1)

Targets (1)