Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes

Inclusion Criteria:

• ≥60 years old individuals with full civil capacity.
• 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.
• Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or diabetes definitively diagnosed by a community-level or higher medical institution. Patients with hypertension: systolic pressure <160 mmHg and diastolic pressure <100 mmHg on the day of immunization achieved by lifestyle adjustment and/or drug treatment; patients with diabetes: fasting glucose ≤13.9 mmol/L on the day of (or within 3 days before) immunization achieved by lifestyle adjustment and/or drug treatment.

Exclusion Criteria:

• Previously confirmed or asymptomatic COVID-19 patient.
• 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.