Clinical Trial on Sequential Immunization of Recombinant COVID-19 Vaccine (CHO Cells) and Inactivated COVID-19 Vaccine (Vero Cells) in Population Aged 18 Years and Above
NCT ID: NCT05033847
Last Updated: 2023-02-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
1800 participants
INTERVENTIONAL
2021-09-12
2024-01-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Subject last vaccination time is within 30-90 days
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 30-90 days
Recombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm
COVID-19 vaccine (Vero cells)
Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Subject last vaccination time is within 91-180 days
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time is within 91-180 days
Recombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm
COVID-19 vaccine (Vero cells)
Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Subject last vaccination time more than 181 days
Subject have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell).The last vaccination time more than 181 days
Recombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm
COVID-19 vaccine (Vero cells)
Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Interventions
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Recombinant COVID-19 Vaccine (CHO cell)
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm
COVID-19 vaccine (Vero cells)
Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Eligibility Criteria
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Inclusion Criteria
* Judged by the investigator that the health condition is well after inquiry and physical examination;
* Vaccinated with 2 doses of CNBG inactivated COVID-19 vaccine according to the product insert;
* Female subjects who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 6 months after enrolment. Effective contraceptive measures have been taken within 2 weeks before inclusion.
* During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan; Self has ability to understand the study procedures, the informed consent \& voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.
Exclusion Criteria
* With a history of SARS and MERS infection (self-report, on-site inquiry);
* Has vaccinated with any vaccine other than one or more doses of CNBG inactivated COVID-19 vaccine;
* Axillary temperature ≥ 37.3 ℃ (forehead temperature ≥ 37.8 ℃);
* Previous severe allergic reactions to vaccination (such as acute allergic reactions, urticaria, dyspnea, angioneurotic edema or abdominal pain) or allergy to known components of recombinant COVID-19 vaccine;
* Allergic to any component of the study vaccine (e.g. aluminum, histidine, etc.)
* Known or suspected diseases include：Severe respiratory diseases, severe liver and kidney diseases, hypertension (systolic blood pressure ≥ 150 mmHg, diastolic blood pressure ≥ 90 mmHg), diabetic complications, malignant tumors, various acute diseases or acute attacks of chronic diseases;
* Has been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
* Has a history of convulsions, epilepsy, encephalopathy，long term history of alcohol and drug abuse, history of thyroidectomy, infectious diseasesor mental illness or family history（lineal）;
* With Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
* Has a history of coagulation dysfunction (e.g. coagulation factors deficiency and coagulation diseases);
* Absence of spleen or splenectomy, functional absence of spleen caused by any condition
* Anti -TB (TB) treatment is under way.
* Patients receiving immunoenhancement or inhibitor therapy within 3 months (continuous oral or IV administration for more than 14 days);
* Received other vaccines within 14 days before vaccination；
* Received blood products before within 3 months before vaccination;
* Received other investigational drugs within 6 months before vaccination;
* Plan to move before the end of the study or leave the local area for a long time during the scheduled study visit
* Other circumstances judged by investigators that are not suitable for this clinical trial
18 Years
ALL
Yes
Sponsors
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China National Biotec Group Company Limited
INDUSTRY
Lanzhou Institute of Biological Products Co., Ltd
INDUSTRY
National Vaccine and Serum Institute, China
INDUSTRY
Responsible Party
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Locations
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Sheikh Khalifa Medical City
SEHA, Abu Dhab, United Arab Emirates
Countries
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Other Identifiers
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CNBG 2021001
Identifier Type: -
Identifier Source: org_study_id
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