Immunogenicity and Safety of COVID-19 Vaccine as a Booster Vaccination in Population Aged 18 Years and Above

Receipt of any COVID-19 prophylactic medication other than inactivated COVID-19 vaccine (e.g., receipt history of any approved or under developing COVID-19 vaccines, or other COVID-19 prophylactic medication, etc.), or previous vaccination history other than two- or three-dose inactivated COVID-19 vaccination;

Systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg or axillary body temperature ≥ 37.3°C prior to enrolment;

Known allergy, or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients;

History of severe acute respiratory syndrome (SARS) or Middle East respiratory syndrome (MERS);

History of COVID-19, or close contact with a confirmed/suspected COVID-19 patient or positive results for SARS-CoV-2 nucleic acid ;

Receipt of any live attenuated vaccine within 28 days prior to vaccination, and other vaccines such as subunit and inactivated vaccine within 14 days prior to vaccination;

Receipt of blood or blood-related products, including immunoglobulins, monoclonal antibodies, within 3 months prior to vaccination; or any planned use during the study period.

Subjects with the following diseases:

1. Any acute diseases or acute attacks of chronic diseases within 7 days prior to enrolment；
2. Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.；
3. Congenital or acquired immunodeficiency or autoimmune disease, or long-term receipt (>14 consecutive days) of glucocorticoid (reference value for dose: ≥20 mg/day prednisone or equivalent) or other immunosuppressive agents within the past 6 months, with exception of inhaled or topical steroids, or short-term use (≤14 consecutive days) of oral corticosteroids；
4. Currently suffering from or diagnosed with infectious diseases, such as hepatitis B, hepatitis C, syphilis, AIDS etc.；
5. History or family history of neurological disorders (convulsions, epilepsy, encephalopathy, etc.) or psychiatric disorders；
6. Asplenia, or functional asplenia；
7. Presence of severe, uncontrollable or hospitalized cardiovascular diseases, endocrine diseases, blood and lymphatic diseases, immune diseases, liver and kidney diseases, respiratory diseases, metabolic and skeletal diseases, or malignant tumors;
8. Contraindications to IM injections and blood draws, such as coagulation disorders, thrombotic or bleeding disorders, or conditions that needs continuous anticoagulant usage.

Drug or alcohol abuse (alcohol intake ≥ 14 units per week) which in the investigator's opinion would compromise the participant's safety or compliance with the study procedures;

Pregnant or lactating females;

Having participated or participating in COVID-19 related clinical trials, and those participating or planning to participate in other clinical trials during the study period;

Presence of any underlying disease or condition which, in the opinion of the investigator, may place the subject at unacceptable risk, is unable to meet the requirements of the protocol, or interfere with the assessment of vaccine response