Clinical Study on the Immune Program of Recombinant Novel Coronavirus（COVID-19) Vaccine (CHO Cell)

This is an interventional prevention trial for Coronavirus Disease 2019 Read More

Inclusion Criteria:

1. Persons over the age of 18 with full capacity for civil conduct;
2. The subject voluntarily agrees to participate in the study and signs the informed consent, and can provide valid identification, understand and comply with the requirements of the study protocol;
3. Fertile male and female subjects of reproductive age agreed to use effective contraceptive measures from the beginning of the study to 2 months after full vaccination.

Exclusion Criteria:

1. Suspected or confirmed fever within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
2. Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angiopantic edema, etc.; Or have a history of severe adverse reactions to any of the above mentioned vaccines or medications;
3. people who currently have or have a history of COVID-19;

4. Persons suffering from the following diseases:

   ① have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.;

   ② Congenital or acquired immune deficiency or autoimmune disease history or received immunomodulatory treatment within 6 months Treatment, such as immunosuppressive doses of glucocorticoid (dose reference: equivalent to prednisone 20mg/ day, more than one weeks); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical application (e.g. ointments, eye drops) is allowed Liquid, inhalant or nasal spray);

   ③ Have been diagnosed with a known infectious disease, such as active tuberculosis, viral hepatitis, human immunodeficiency virus or treponema pallidum;

   ④ Neurological disorders (e.g., convulsions, migraines, epilepsy, stroke, epileptic seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of mental illness or family history;

   ⑤ functional absence of spleen, and absence of spleen or splenectomy caused by any reason;

   ⑥ There are serious chronic diseases or diseases in the progressive stage can not be controlled smoothly, such as diabetes, drugs can not control Hypertension (systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg);

   ⑦ Severe liver and kidney diseases; Any current respiratory illness requiring routine medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any exacerbation of respiratory illness (e.g., exacerbation of asthma) within the last 5 years; A history of serious cardiovascular disease (e.g., congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis;

   ⑧ Cancer patients (except basal cell carcinoma).

5. had taken an antipyretic or painkiller within 24 hours before the first dose of vaccine;
6. Those who have received novel coronavirus vaccine, or subunit vaccine and/or inactivated vaccine within 7 days before the first dose, or live attenuated vaccine within 14 days;
7. Have received blood or blood-related products, including immunoglobulin, within 3 months; Or planned for use during the study period;
8. Lactating or pregnant women (including women of childbearing age who have positive urine pregnancy test), or women who plan to have a pregnancy within 2 months after full vaccination of the test vaccine or their partners;
9. Have participated in or are currently participating in other COVID-19 related clinical trials;
10. The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.