Status:
UNKNOWN
Immunogenicity and Safety of Booster Immunization of ZF2001 After Inoculation With Two Doses of BBIBP-CorV
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Collaborating Sponsors:
Zhejiang Provincial Center for Disease Control and Prevention
Conditions:
COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief 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 ...
Detailed Description
This trial plans to enroll 480 subjects, who will be divided into 3 groups according to the interval between booster immunization and basic immunization: group A (3-4 months), group B (5-6 months), gr...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 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.
Key Trial Info
Start Date :
November 10 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
480 Patients enrolled
Trial Details
Trial ID
NCT05205083
Start Date
November 10 2021
End Date
July 1 2022
Last Update
January 24 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Zhejiang Provincial Center for Disease Control and Prevention
Hangzhou, Zhejiang, China, 310051