Safety and Immunogenicity of COVID-19 Vaccine in Population Aged 18 Years and Above

This is an interventional prevention trial for COVID-19 Read More

Inclusion Criteria:

• Aged 18 years and above.
• Participate the trial voluntarily and sign informed consent form.
• Subjects are willing to comply with the requirements of the clinical trial protocol -and complete the study follow-up.
• Armpit temperature ≤37.0℃ on the day of enrollment.
• Novel Coronavirus (COVID-19) Antibody (IgG and IgM) was negative.

Exclusion Criteria:

• Known allergy to investigational vaccine or its excipients, or previous history of anaphylactic shock or other serious adverse reactions to other vaccines
• History of severe acute respiratory syndrome (SARS) and/or Middle East respiratory syndrome (MERS) infection or disease;
• History of COVID-19, or close contact with a confirmed/suspected COVID-19 patient, or SARS-CoV-2 nucleic acid test was positive or antibody test (IgG, IgM) was positive;
• Used antipyretic drugs, painkillers or anti-allergic drugs within 24 h before enrollment;
• Has received COVID-19 vaccine;
• vaccination of subunit vaccines and/or inactivated vaccines within 7 days before enrollment, or vaccination of live attenuated vaccines within 14 days before enrollment;
• Administration of blood or blood related products (including immunoglobulins) within 3 months before enrollment; or plan to use during the trial;

• Patients with the following diseases:

  1. Any acute disease or in the acute phase of chronic diseases within 7 days before enrollment;
  2. Congenital malformation or developmental disorder, genetic defect, severe malnutrition, etc.;
  3. History of congenital or acquired immunodeficiency or autoimmune diseases, or long-term(used continuously>14 days)use of glucocorticoid (dose ≥ 20 mg/day prednisone or equivalent dose) or other immunosuppressants within the last 6 months, yet the following situations are allowed to be included: inhaled or topical use of external steroids, or short-term use (course ≤ 14 days ) of oral corticosteroids;
  4. Known diagnosis of or having infectious diseases, or positive for any one of HBsAg, anti-HCV antibody, anti-TP antibody or anti-HCV antibody;
  5. Neurological diseases or family history (convulsion, epilepsy, encephalopathy, etc.); history of psychosis or family history;
  6. Asplenia or functional asplenia;
  7. Serious or uncontrollable cardiovascular diseases, diabetes, hematological and lymphatic diseases, immune system diseases, liver and kidney diseases, respiratory diseases, metabolism and bone diseases, or malignant tumors that need hospitalization;
  8. Contraindications of intramuscular injection and blood drawing, such as coagulation dysfunction, thrombosis or hemorrhagic diseases, or any condition that needs continuous use of anticoagulant;
  9. Severe hypertension with uncontrolled medication (at field measurement: systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg) History of major surgery within 12 weeks before enrollment (in the opinion of the investigator), or incomplete recovery after surgery, or planning major surgery during the trial;
• Participating or will participate other clinical trials during this trial;
• Any disease or condition that, in the opinion of the investigator, would pose an unacceptable risk to the subject; the subject is unable to meet the protocol requirement; will interfere with evaluation of investigational vaccine.
• Women who were breastfeeding or pregnant during the clinical study or planned to become pregnant during the study;