Immunogenicity and Safety of Recombinant COVID-19 Vaccine (CHO Cells)

Inclusion Criteria:

• Healthy subjects of ≥ 18 years old.
• The subject can understand and voluntarily sign the informed consent.
• Axillary temperature ≤37.0℃.
• General good health as established by medical history and physical examination

Exclusion Criteria:

• Have a history of close contact with a confirmed case of SARS-CoV-2, an asymptomaticinfection in the previous 14 days, or a travel history/residential history in acommunity where a case has been reported.
• Have a history of contact with a person infected with SARS-CoV-2(a person with apositive nucleic acid test) in the previous 14 days.
• Patients with fever or respiratory symptoms who have been to middle or high-risk areasin the past 14 days or have exit history, or come from communities with case reports.
• In the past 14 days, there have been 2 or more cases of fever and/or respiratorysymptoms in small areas such as homes, offices, school classes, etc.
• Have a history of SARS.
• Have a history of SARS-CoV-2 infection or history of Coronavirus Vaccination (including Emergency Vaccine and Experimental Vaccine).
• Positive in SARS-CoV-2 IgG or IgM antibody screening.
• Have a history of HIV infection;
• Women who are breastfeeding, pregnant, or planning to become pregnant during 6 monthsafter full-course vaccination (based on the subject's self-report and blood pregnancytest results for women of childbearing age).
• Have a history of asthma, a history of vaccine or vaccine component allergy, haveserious adverse reactions to the vaccine, such as urticaria, dyspnea, angioedema.
• Subjects with congenital malformations or developmental disorders, genetic defects,severe malnutrition, etc.
• Subjects with autoimmune diseases or immunodeficiency/immunosuppression.
• Subjects with severe chronic diseases, severe cardiovascular diseases,hypertension(sbp≥160mmHg and/or dbp≥100mmHg) and diabetes that cannot be controlled bydrugs, liver and kidney diseases, malignant tumors, etc.
• Subjects with severe neurological disease (epilepsy, convulsions or convulsions) ormental illness.
• Subjects with thyroid disease or history of thyroidectomy, no spleen, functionalasthenia, and any spleen or splenectomy caused by any condition.
• Abnormal blood coagulation function diagnosed by a doctor (such as coagulation factordeficiency, coagulopathy, abnormal platelet) or obvious bruise or coagulationdisorder.
• Have received immunosuppressant therapy, cytotoxic therapy, and inhaledcorticosteroids in the past 6 months (excluding corticosteroid spray therapy forallergic rhinitis and surface corticosteroid therapy for acute non-complicateddermatitis).
• Received blood products within 3 months before receiving trial vaccine.
• Received other study drugs within 30 days before receiving the trail vaccine.
• Received a live attenuated vaccine within 14 days before receiving the experimentalvaccine.
• Received a subunit or inactivated vaccine within 7 days before receiving theexperimental vaccine.
• Various acute or chronic diseases occurred in the past 7 days.
• Have a long history of alcohol or drug abuse.
• Had urticaria one year before receiving the experimental vaccine;
• congenital or acquired angioedema/neuroedema;
• According to the judgment of the investigator, the subject has any other factors thatare not suitable for participating in the clinical trial, or Or influence the subjectto sign the informed consent. Exclusion criteria of subsequent dose:
• Patients with severe allergic reactions after the previous dose of vaccination;
• Patients with serious adverse reactions causally related to the previous dose ofvaccination.
• For those newly discovered or newly discovered after the first vaccination that doesnot meet the first-dose selection criteria or meets the first-dose exclusion criteria,the investigator will determine whether to continue participating in the study.
• Other exclusion reasons suggested by the researchers.