Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
0, 14 emergency vaccination group:0, 14 day immunization procedure
0, 21 emergency vaccination group:0, 21 day immunization procedure
0, 28 emergency vaccination group:0, 28 day immunization procedure
Sponsors
Shanxi Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-59 years; 2. The subjects who signed the informed consent form and participated voluntarily; 3. Subjects with good compliance; 4. Subjects with the interval of more than 14 days from the last vaccination; 5. Before entering this study, subjects with history and clinical examination and body temperature <= 37.0 degrees C.
Exclusion criteria
Exclusion criteria: 1. Patients with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history; 2. Those who are allergic to any component of the vaccine, and those who have had any history of severe allergy to the vaccine (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema or abdominal pain); 3. Patients with immunodeficiency, cancer treatment, immunosuppressive therapy (oral steroids) or HIV induced hypoimmunity, or close family members with congenital immune diseases; 4. Patients injected with non-specific immunoglobulin within one month before enrollment; 5. Patients with severe liver and kidney diseases, respiratory diseases, cardiovascular diseases, malignant tumors; diabetic complications beyond the control of drugs; acute attack of various acute or chronic diseases; infectious, suppurative and allergic skin diseases; 6. Patients injected with non-specific immunoglobulin within one month before enrollment; 7. Patients with acute febrile diseases and infectious diseases whose body temperature is more than 37.0 degrees C; 8. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 28 days after the last dose of vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| The specific immune cell level of SARS-CoV-2 in whole blood 28 days after the last dose of vaccination;Local and systemic adverse reactions/events within 7 days and 6 months after each dose;Serious adverse events (SAE) during the entire study period (6 months after the full vaccination;Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 at months 3, 6, and 12 after the last dose of vaccination;Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 after enhancing immunity of vaccination; | — |
Countries
China
Contacts
Public ContactJing Chen
Shanxi Provincial Center for Disease Control and Prevention
Outcome results
None listed