COVID-19
Conditions
Interventions
Dose group 1 :Receive the corresponding dose of test vaccine or placebo
Dose group 2:Receive the corresponding dose of test vaccine or placebo
Sponsors
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese residents aged 18 years and above who can provide legal identification; 2. Volunteers who meet the requirements for participating in clinical trials based on medical history and physical examination; 3. Have the ability to understand the study procedure, sign the informed consent voluntarily and comply with it Adhere to the requirements of the clinical study protocol.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose: 1. Novel coronavirus previous case or previous nucleic acid test positive, nucleic acid test positive; 2. Novel coronavirus antibody positive; 3. Visited overseas, high-risk areas in China or villages/communities that have been affected by COVID-19 in the past one month, or have been in contact with infected or suspected cases of novel coronavirus; 4. Other novel coronavirus vaccines; 5. Allergic to paracetamol; 6. Pregnant women with positive pregnancy test who are pregnant, breast-feeding, or receiving the first dose, women and men who planned to have a pregnancy within 6 months of the vaccine were not effective in the 2 weeks prior to enrollment contraceptive methods; 7. A history of epilepsy, convulsions, mental illness and family history; 8. Previous allergies to any medicines or vaccines (e.g. acute anaphylaxis, urticaria, respiratory distress refractory, angoneeurotic edema or abdominal pain) or allergic to known components of the novel coronavirus vaccine; 9. A history of hospital-diagnosed thrombocytopenia or other coagulotting disorders; 10. Patients with known immunological impairment or depression diagnosed in the hospital, such as patients with thyroid disease or thyroid History of resection, absence of spleen, functional absence of spleen, and absence of spleen or splenectomy due to any circumstance; 11. Received whole blood, plasma and immunoglobulin therapy within 1 month; 12. Severe respiratory disease, liver or kidney disease, acute infection or chronic disease, diabetes, malignant tumors, severe skin diseases, HIV positive; anti-tuberculosis drugs are being administered; 13. Having serious cardiovascular disease (cardiopulmonary failure, hypertension that cannot be controlled by medication (physical contractions), blood pressure >= 150 mmHg or diastolic blood pressure >= 100 mmHg) Chinese guidelines for prevention and treatment of hypertension (3rd edition) revised in 2021); 14. Blood biochemistry and blood routine before inoculation, urine routine, coagulation function, thyroid function, myocardium, abnormalities with inflammatory related indicators of clinical significance; 15. Receiving live attenuated vaccines within 14 days and other vaccines within 7 days; 16. Armpit temperature > 37.0?; 17. Contraindications considered by other researchers to be associated with vaccination. Note: Increased ALT, AST and total bilirubin, abnormal white blood cells, decreased lymphocytes and neutrophils, activated partial coagulation prolonged active enzyme time, increased INR, decreased fibrinogen, abnormal grade of any of the above indicators reached grade 1, enrollment must be evaluated by an authorized clinician; the grade of thrombocytopenia abnormality reached grade 2, which should be evaluated by an authorized clinician before enrollment; abnormal grade of urine routine examination (urine protein and urine red blood cell) reached grade 1, which can be re-examined and evaluated for inclusion; the blood test for beta-human chorionic gonadotropin in fertile women (WOCBP) must be negative and menopausal women who are later (continuous menopause for more than 12 months) or who are permanently sterilized are considered to have no reproductive potential. For receiving screening subjects receiving the first dose of vaccine should have a urine pregnancy test only once before the study intervention. Exclusion criteria for subsequent stitches 1. Positive urine pregnancy test
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Adverse events associated with the experimental vaccine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT), Geometric mean Growth Multiple (GMI), seroprevalence of anti-Novel Coronavirus antibody;Laboratory related examination for adverse events;SAE, Sever Adverse Events;AESI, Adverse Events Of Special Interest; | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Outcome results
None listed