COVID-19
Conditions
Interventions
Adult group: Vaccine versus placebo group:0, 21, 42 days immunity
Elder group: Vaccine versus placebo:0, 21, 42 days immunity
Immunogenic subgroup group: Vaccine versus placebo:0, 21, 42 days immunity
Sponsors
Jiangsu Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-85 years; 2. Obtain the informed consent of the subjects and sign the informed consent form; 3. Subjects are able and willing to comply with the requirements of the clinical trial protocol, and can complete the study follow-up for approximately 14 months. -Axillary body temperature <= 37.0 degree C.
Exclusion criteria
Exclusion criteria: 1. The 2019 novel coronavirus antibody (IgG and IgM) screening is positive. 2. The 2019 novel coronavirus nucleic acid test is positive. 3. 2019 new coronavirus infection history and 2019 new coronavirus vaccination history. 4. Known history of HIV infection. 5. Those with medical or family history of convulsions, epilepsy, encephalopathy, and mental illness. 6. Those who are allergic to any ingredient in the research vaccine, have a history of severe vaccine allergic reactions and allergies in the past. 7. Women who have a positive urine pregnancy test, are pregnant, breastfeeding, or have a pregnancy plan during the study period (within 14 months). 8. Patients with acute febrile diseases and infectious diseases. 9. Those who self-report a history of SARS. Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, severe hypertension and uncontrollable medication, etc. 10. Suffer from severe chronic diseases or the disease is in the advanced stage and cannot be controlled smoothly, such as asthma, diabetes, thyroid disease, etc. 11. Malignant tumors, active tumors or tumors that have been treated without clear cure, or may recur during the study period. -Congenital or acquired angioedema/neuroedema. 12. Had urticaria 1 year before receiving the trial vaccine; 13. Aspleen or functional aspleen; 14. Suffer from thrombocytopenia or other coagulation disorders (may cause contraindication to intramuscular injection); 15. Fainted needles; 16. Have received immunosuppressant therapy, anti-allergic therapy, cytotoxic therapy, and inhaled corticosteroids in the past 6 months (excluding corticosteroid spray therapy for allergic rhinitis and surface corticosteroid therapy for acute non-complicated dermatitis); 17. Received blood products within 4 months before receiving the test vaccine; 18. Received other study drugs within 1 month before receiving the test vaccine; 19. Received a live attenuated vaccine within 1 month before receiving the test vaccine; 20. Received subunit or inactivated vaccine within 14 days before receiving the test vaccine; 21. The onset of various acute or chronic diseases in the past 7 days, such as being receiving anti-tuberculosis treatment and a history of asthma; 22. According to the investigator's judgment, due to various medical, psychological, social or other conditions, it is contrary to the trial protocol or affects the subjects to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse reactions (AR) 0-7 days after each immunization;The incidence of Adverse Events of Special Concern (AESI) from the first to 60 days after the last immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events (AE) from the first to 30 days after the last immunization;The incidence of grade 3 and above adverse events from the first to 30 days after the last immunization;The incidence of serious adverse events (SAE) from the first to 12 months after the last immunization;The geometric mean titer (GMT) of anti-2019 novel coronavirus S-RBD protein specific antibody (ELISA method) in the immunogenic subgroup 30 days, 60 days, 6 months, and 12 months after the last immunization;The geometric mean titer (GMT) of the anti-2019 novel coronavirus-specific neutralizing antibody (neutralization test method for live virus and pseudovirus) in the immunogenic subgroup 30 days, 60 days, 6 months, and 12 months after the last immunization);The geometric mean titer (GMT) of the anti-2019 novel coronavirus-specific neutralizing antibody (neutralization test method for live virus and pseudovirus) in the immunogenic subgroup 30 days, 60 days, 6 months, and 12 months after the last immunization);The geometric mean growth multiple (GMI) of the S-RBD protein specific antibody (ELISA method) against the 2019 novel coronavirus 30 days, 60 days, 6 months, and 12 months after the last immunization of the immunogenic subgroup;Positive conversion rate of anti-2019 novel coronavirus specific neutralizing antibody (neutralization test method for live virus and pseudovirus) in the immunogenic subgroup 30 days, 60 days, 6 months, and 12 months after the last immunization;The geometric mean multiplier (GMI) of anti-2019 novel coronavirus-specific neutralizing antibodies (neutralization test method for live virus and pseudovirus) in the immunogenic subgroup of people 30 days, 60 days, 6 months, and 12 months after the last immunization; | — |
Countries
China
Contacts
Public ContactYuquan Wei
West China Hospital, Sichuan University
Outcome results
None listed