Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
A1:medium dosage
A2:high dosage
A3:placebo
A4:medium dosage
A7:medium dosage
A8:high dosage
A9:placebo
B1:medium dosage
B2:high dosage
B3:placebo
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention (Public Health Research Institute of Jiangsu Province)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy permanent residents aged 18 years and above; 2. Subjects agree to sign the informed consent forms voluntarily; 3. Subjects are able to comply with the requirements of the clinical trial protocol; 4. Armpit temperature <= 37.0 degrees C; 5. Female subjects of childbearing age were not pregnant at the time of enrollment, were not breastfeeding, and had no birth plan within the first 3 months after enrollment; effective contraceptive measures had been taken within 2 weeks before enrollment.
Exclusion criteria
Exclusion criteria: 1. Within 14 days before vaccination, subjects have been abroad and to villages/communities experienced COVID-19 epidemics, and in contact with COVID-19 cases or suspected cases. Subjects are under isolation observation, or living in the villages/communities with COVID-19 cases or suspected cases; 2. Confirmed cases, suspected cases or asymptomatic cases with COVID-19 (refer to Information System of China Disease Prevention and Control); 3. Subjects with history of SARS virus infection by self-reported; 4. Positive in throat swab through RT-PCR; 5. Positive in SARS-CoV-2 antibody test; 6. Subjects with history of severe allergic reactions (such as acute anaphylaxis, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain) or allergy to known composition of inactivated SARS-CoV-2 vaccine; 7. Subjects with history of convulsion, epilepsy, encephalopathy or mental illness or family history; 8. Subjects with congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; 9. Subjects with known or suspected diseases include: severe respiratory diseases, severe cardiovascular diseases, severe liver and kidney diseases, uncontrollable hypertension (systolic pressure >=140 mmHg, diastolic pressure >= 90 mmHg; subjects aged >= 60 years with systolic pressure >=150 mmHg, diastolic pressure >=100 mmHg), diabetic complications, malignant tumors, various acute diseases or acute onset of chronic diseases; 10. Subjects diagnosed with congenital or acquired immune deficiency, HIV infection, lymphoma, leukemia or other autoimmune diseases; 11. Subjects with history of coagulation dysfunction (e.g. Coagulation factor deficiency, coagulation disease); 12. Subjects receiving anti-TB treatment; 13. Subjects receiving other research drugs within 6 months before vaccination; 14. Subjects receiving immunotherapy or inhibitor therapy within 3 months (consistently oral or infusion for more than 14 days); 15. Subjects receiving blood products within 3 months before administration; 16. Subjects vaccinated with live attenuated vaccine within 14 days before vaccination; 17. Subjects vaccinated with other vaccine within 7 days before vaccination; 18. The researchers shall judge the other conditions which might be not in compliance with the reequipments of this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The seropositive rates and level of SARS-CoV-2 neutralizing antibody;The seropositive rates of SARS-CoV-2 IgG antibody (tested by ELISA); | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reactions/events;Serious Adverse Events (SAE);Level of SARS-CoV-2 IgG antibody (tested by ELISA);The seropositive rates and level of SARS-CoV-2 neutralizing antibody and IgG antibody (tested by ELISA);The seropositive rates and level of SARS-CoV-2 neutralizing antibody and IgG antibody (tested by ELISA); | — |
Countries
China
Contacts
Public ContactPan Hongxing
Jiangsu Provincial Center for Disease Control and Prevention
Outcome results
None listed