Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Group 1:inactivated Novel Coronavirus Pneumonia vaccine (Vero cells)
Group 2:Novel Coronavirus Pneumonia mRNA vaccine (DF104B1)
Sponsors
Shanghai East Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged over 18 years; 2. Received two doses of the new crown inactivated vaccine at least 4 months ago; 3. According to the medical history and physical examination, the researchers judged to be healthy (excluding the following conditions: known or suspected to suffer from more serious diseases at the same time, including: respiratory diseases, acute infections or active chronic diseases, liver and kidney diseases, malignant tumor, infectious disease, allergic skin disease, HIV infection (test report can be provided); 4. Those who have not been abroad in the past 2 months and have experienced outbreaks in villages/communities, who have not been in contact with people infected with the new coronavirus or suspected cases, who are in the non-isolation period, and who have not been infected with the new coronavirus in the same village/community or suspected cases; 5. Patients are willing to complete the entire study follow-up and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. The new coronavirus antibody test is positive, and the new coronavirus nucleic acid test is positive; 2. Have a history of SARS/MERS virus infection (self-report, on-site inquiry); 3. Have been vaccinated against other novel coronavirus vaccines; 4. Those who have a history of allergy to phenol and Mamemin; 5. Women with positive urine pregnancy test, pregnant, breastfeeding, or women planning to become pregnant within 12 months; 6. Those with a medical history or family history of allergies, convulsions, epilepsy, encephalopathy and mental illness; 7. Any history of allergy to drugs or vaccinations (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioedema or abdominal pain) or allergy to known components of the new coronavirus vaccine; 8. Severe cardiovascular disease diagnosed by the hospital (cardiopulmonary failure, hypertension that cannot be controlled by drugs, etc.); 9. History of thrombocytopenia or other coagulation disorders diagnosed by the hospital; 10. Those who have received whole blood, plasma and immunoglobulin therapy within 3 months; 11. Patients with clinically significant abnormalities in blood biochemistry, blood routine, and urine routine related indexes detected before vaccination in Phase I clinical study; 12. Those with symptoms of fever (axillary temperature>37.3?), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, shortness of breath and dyspnea within 14 days before vaccination; 13. Received live attenuated vaccine within 1 month before vaccination, and received other vaccines within 14 days before vaccination; 14. Those with axillary body temperature >37.3? during vaccination; 15. Contraindications related to vaccination in the opinion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Adverse reactions; | — |
Secondary
| Measure | Time frame |
|---|---|
| Virus specific antibody;Virus neutralizing antibody;Indicators of blood infectious diseases;Blood routine test;Blood biochemical index;Coagulation function;Urine examination;HbA1c;Infection index;Novel Coronavirus Pneumonia nucleic acid test;Whole blood transcriptome;Peripheral blood mononuclear cell; | — |
Countries
China
Contacts
Public ContactLiu Zhongming
Shanghai East Hospital
Outcome results
None listed