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 years with malignant tumors; 2. Before entering the study, after medical history and clinical diagnosis, no clear signs of acute infection, and body temperature = 12 months; 5. Able and willing to complete the entire prescribed research plan during the entire study follow-up period; 6. 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; 7. Eastern Cooperative Oncology Group (ECOG) performance status score =0.5x10^9/L, lymphocyte count >=0.5x10^9/L, hemoglobin >=60g/L, platelet count >=50x10^9/L; (2) Serum total bilirubin (TBIL) <= 3 times ULN, aspartate aminotransferase (aspartate aminotransferase) AST (SGOT) <= 5 times ULN, alanine aminotransferase (alanine aminotransferase) ALT (SGPT) )<=5 times ULN (for patients with liver cirrhosis, Child-Pugh class A), serum creatinine<=3 times ULN [for chronic kidney disease patients, kidney disease prognosis quality assessment (K/DOQI) stage<=3 stage]; (3) Cardiac function of the New York Heart Association (NYHA) class <= II.
Exclusion criteria
Exclusion criteria: 1. Confirmed cases of novel coronavirus 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. Those whose primary disease or complication is in the acute phase; 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. The investigator believes that the patient has bleeding tendency and/or coagulation dysfunction; 11. Those less than 6 months after organ transplantation before inclusion in the study, those who had undergone other inpatient operations within 1 month before any dose of vaccination or had undergone outpatient surgery within 1 week; 12. Those who have been vaccinated with live attenuated vaccines within 1 month before any dose of vaccination, and other vaccines within 14 days before any dose of vaccination; 13. Those who participated in other vaccine clinical trials during this study; 14. Less than 3 months after chimeric antigen receptor T cell (CAR-T) therapy; 15. Those less than 3 months after autologous hematopoietic stem cell transplantation (auto-HSCT) or allogeneic hematopoietic stem cell transplantation (allo-HSCT).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Novel coronavirus antibody 4 times growth rate and antibody level; | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT and 4-fold increase of IgG antibody at 28 days after the second dose of immunization;GMT and 4-fold increase of IgG antibody at 28 days after the full immunization; | — |
Countries
China
Contacts
Public ContactShi Yuankai
Cancer Hospital, Chinese Academy of Medical Sciences
Outcome results
None listed