Phase I Clinical Trial of GEN2-Recombinant COVID-19 Vaccine (CHO Cells) in Healthy People Aged 18 and Above

Exclusion Criteria

• •Confirmed cases, suspected cases, asymptomatic infections, or close contacts of the above-mentioned groups of SARS-CoV-2 infection (check "China Disease Prevention and Control Information System");
• •Axillary body temperature ≥37.3℃ before vaccination;
• •Positive test for novel coronavirus antibody (IgG+IgM);
• •Have a history of SARS virus infection (self-report, on-site inquiry);
• •Fever (axillary temperature ≥37.3℃), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath, and dyspnea within 14 days before vaccination;
• •The test results of blood biochemistry, blood routine, urine routine and coagulation function-related indexes before vaccination are abnormal, which are beyond the reference value range and have clinically significant abnormalities;
• •Severe allergic reactions (such as acute allergic reactions, urticaria, skin eczema, dyspnea, angioedema or abdominal pain) have occurred in the past;
• •Allergy to any component of the study vaccine (such as: aluminum, histidine, etc.);
• •Patients with convulsions, epilepsy, encephalopathy or other progressive neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.), long-term history of alcohol and drug abuse, history of thyroidectomy, infectious diseases, mental illness medical or family history;
• •Known or suspected diseases include: severe respiratory disease, severe liver and kidney disease, severe cardiovascular disease, uncontrolled hypertension (systolic blood pressure ≥140mmHg, diastolic blood pressure ≥90mmHg), diabetic complications, malignant tumors, Various acute diseases, acute exacerbations of chronic diseases or severe chronic diseases;
• •Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases;
• •Thrombocytopenia, history of abnormal coagulation function (such as coagulation factor deficiency, coagulation disease);
• •Asplenia or splenectomy, functional asplenia caused by any circumstance;
• •Are receiving anti-TB (tuberculosis) treatment;
• •Received immune enhancement or inhibitor therapy within 3 months (continuous oral or infusion for more than 14 days);
• •Received live attenuated vaccine within 28 days before vaccination, and received other vaccines within 14 days before vaccination;
• •Received blood products within 3 months before vaccination;
• •Received other study drugs within 6 months before vaccination;
• •Planning to move before the end of the study or to be away from the local area for an extended period of time during a scheduled study visit;
• •The investigator judges other circumstances that are not suitable to participate in this clinical trial.
• •Positive urine pregnancy test;
• •Patients with abnormal conditions such as high fever (axillary temperature ≥39.0℃) for three days, convulsions, severe allergic reactions or any adverse reactions of the --Nervous system after the previous dose of vaccination;
• •Serious adverse reactions that are causally related to the previous dose of vaccination;