Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
0, 14 emergency vaccination group:two doses of vaccine at the schedule of day 0, 14
0, 28 emergency vaccination group:two doses of vaccine at the schedule of day 0, 28
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 old; 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. Subjects with history of allergy, convulsion, epilepsy, encephalopathy and psychosis or family history; 2. Patients who are allergic to any component of the vaccine, and have a 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. Subjects 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. Subjects injected with non-specific immunoglobulin within one month before enrollment; 7. Subjects 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;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; | — |
Secondary
| Measure | Time frame |
|---|---|
| Serum neutralizing antibodies, IgG antibodies, and IgM antibodies of SARS-CoV-2 after enhancing immunity of vaccination;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; | — |
Countries
China
Contacts
Public ContactJing Chen
Shanxi Provincial Center for Disease Control and Prevention
Outcome results
None listed