Novel coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Sponsors
China National Biotec Group Co.Ltd
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Those aged 18 and above suffering from damage to vital organs; 2. Before entering the study, there are no clear signs of acute infection, and the body temperature is = 12 months; 5. Those who have not been vaccinated against the new coronavirus before; 6. Able and willing to complete the entire prescribed research plan during the entire study follow-up period; 7. I have the ability to understand the research procedures, sign the informed consent form voluntarily after informed consent, and be able to comply with the requirements of the clinical research protocol; 8. Damage to important organs includes the following diseases with a clear clinical diagnosis: (1) Liver damage [total bilirubin= 15 mL/(min·1.73m2)]: renal biochemical abnormalities caused by nephrotic syndrome, glomerulonephritis, etc. Impaired function; eGFR was calculated by the CKD-EPI2009Scr formula. 9. Those who have received or plan to receive hormones and/or immunosuppressants and/or other drugs and/or surgery related to the primary disease.
Exclusion criteria
Exclusion criteria: 1. Confirmed cases of novel coronavirus (SARS-CoV-2) infection in the acute phase; 2. Those with a history of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) virus infection (self-report, on-site inquiry); 3. Those who are known to be allergic to any ingredients (including excipients) contained in this product; 4. Those who have experienced severe allergic reactions to vaccines in the past (such as acute allergic reactions, angioedema, dyspnea, etc.); 5. Uncontrolled hypertension (systolic blood pressure>160mmHg, diastolic blood pressure>100mmHg); 6. Those with uncontrolled epilepsy, other progressive neurological diseases or primary diseases involving the nervous system, those with a history of Guillain-Barré syndrome, and those with a history of mental illness; 7. Neutrophil count II; 11. Those with bleeding symptoms of important organs; 12. Those who have malignant tumors of various organ systems or tendencies of malignant tumors; 13. <6 months after organ transplantation, <1 month after other inpatient operations or <1 week after outpatient surgery; 14. Those who have been vaccinated with live attenuated vaccines within 1 month before inclusion in the study and other vaccines within the previous 14 days; 15. Those who are participating in or planning to participate in other vaccine clinical trials during this study; 16. Other reasons for exclusion considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Novel coronavirus antibody 4 times growth rate and antibody level;GMT and 4-fold increase of IgG antibody at 28 days after the second dose of immunization; | — |
Countries
China
Contacts
Public ContactWang Guiqiang
Peking University First Hospital
Outcome results
None listed