Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes
NCT ID: NCT05065892
Last Updated: 2021-10-25
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
PHASE4
1440 participants
INTERVENTIONAL
2021-10-31
2022-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
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Hypertension group
Hypertension group will enroll 330 subjects with hypertension (aged 60 years or older).
COVAX
2 doses of Covid-19 vaccine
Diabetes Mellitus group
Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older).
COVAX
2 doses of Covid-19 vaccine
Combined Disease group
Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older).
COVAX
2 doses of Covid-19 vaccine
Healthy people group
Healthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older).
COVAX
2 doses of Covid-19 vaccine
Interventions
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COVAX
2 doses of Covid-19 vaccine
Eligibility Criteria
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Inclusion Criteria
* Clinically confirmed body temperature of \<37.3°C before enrolling in this study.
* Able and willing to participate in the study plan during the entire study and follow-up period.
* Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol.
Exclusion Criteria
* Has been immunized with a SARS-CoV-2 vaccine.
* Illiterate.
* Known allergy to any ingredient (including excipient) of this product.
* Received non-specific immunoglobulin injection within 1 month before enrollment.
* Received a live attenuated vaccine within 1 month before immunization or other vaccine within 14 days before immunization.
* Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria, angioedema, and dyspnea).
* Has uncontrolled epilepsy and other progressive neurological disorders; history of Guillain-Barré syndrome.
* Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and various acute diseases or acute onset of chronic diseases.
* Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
* Definitively diagnosed with thrombocytopenia or history of other coagulation disorders that may cause subcutaneous injection to be contraindicated.
* Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic acidosis, etc.) of diabetes; or within 2 weeks after recovery from these complications.
* Other physical conditions judged by the investigator that render the patient unsuitable for participation in the clinical study.
60 Years
ALL
Yes
Sponsors
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Guizhou Center for Disease Control and Prevention
OTHER
Hunan Provincial Center for Disease Control and Prevention
OTHER
Center for Disease Control and Prevention, Fujian
OTHER
Wuhan Institute of Biological Products Co., Ltd
INDUSTRY
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
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Locations
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Nan'an Center for Disease Control and Prevention
Quanzhou, Fujian, China
Songtao Miao Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou, China
You County Center for Disease Control and Prevention
Zhuzhou, Hunan, China
Countries
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Central Contacts
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Facility Contacts
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Siqun HU
Role: primary
Jie TAN
Role: primary
Zixiong LIU
Role: primary
Other Identifiers
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COVAX (HT/DM)-Wuhan
Identifier Type: -
Identifier Source: org_study_id