Novel coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:Inactivated COVID-19 vaccine (Vero cell matrix) for patients with autoimmune diseases
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 with autoimmune diseases; 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. Various types of autoimmune diseases with clear clinical diagnosis: including but not limited to systemic lupus erythematosus (SLE), primary Sjogren's syndrome (pSS), antiphospholipid syndrome (APS), systemic vasculitis, systemic Sclerosis (SSc), Inflammatory Myopathy, Rheumatoid Arthritis (RA), Spinal Arthritis (SpA), Gout, Osteoarthritis (OA), Idiopathic Immune Thrombocytopenia (ITP), Psoriasis Wait; 9. Those who have received or plan to receive immunosuppressants, hormones, biological agents, JAK inhibitors, surgery related to the primary disease, etc.; 10. (1) Neutrophil count >= 0.5x10^9/L, (2) Lymphocyte count >= 0.5x10^9/L, (3) Hemoglobin>=60g/L, (4) Platelet count >=20x10^9/L; (5) Serum total bilirubin (TBIL) <= 3 times ULN, (6) Aspartate aminotransferase (aspartate aminotransferase) AST (SGOT) <= 5 times ULN, (7) Alanine aminotransferase (alanine aminotransferase) ALT (SGPT) <= 5 times ULN (for patients with liver cirrhosis, Child-Pugh grade A), (8) Serum creatinine <=3 times ULN [for patients with chronic kidney disease, renal disease prognosis quality assessment (K/DOQI) stage <=3]; (9) Cardiac function New York Heart Association (NYHA) class <=II.
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 of the ingredients (including excipients) contained in this product; 4. Those who have experienced severe allergic reactions to the vaccine 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-barre syndrome, and those with a history of mental illness; 7. Those whose primary disease or complication is in acute phase or critical state; or those who have not fully recovered from serious adverse events caused by the treatment of primary disease or complication; 8. Acute thromboembolism or vascular occlusion; 9. Those with bleeding symptoms of important organs; 10. Those who have malignant tumors of various organ systems or tendencies of malignant tumors; 11. <6 months after organ transplantation, <1 month after other inpatient operations or <1 week after outpatient surgery; 12. 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; 13. Those who are participating in or planning to participate in other vaccine clinical trials during this study; 14. Other reasons for exclusion considered by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Novel coronavirus antibody 4 times growth rate and antibody level; | — |
Secondary
| Measure | Time frame |
|---|---|
| IgG antibody and 4-fold growth rate 28 days after full immunization; | — |
Countries
China
Contacts
Public ContactWang Guiqiang
Peking University First Hospital
Outcome results
None listed