novel coronavirus pneumonia (COVID-19)
Conditions
Interventions
control group:Recombinant COVID-19 vaccine(CHO cell)
Sponsors
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years. 2. Obtain the subject's informed consent and sign the informed consent form. 3. The subject is able and willing to comply with the requirements of the clinical trial protocol and is willing and able to comply with all study plan contents and other requirements of the study. 4. Armpit body temperature < 37.3?. 5. Subjects who have had basic or enhanced immunization with COVID-19 vaccine for 3 months or more; 6. SARS-CoV-2 nucleic acid screening was negative in the last 24 hours. 7. Anti- SARS-CoV-2 IgM antibody was negative during the screening period. 8. BMI of 18.5-30.0 kg/m^2. 9. Women's non-pregnancy period (pregnancy test results are negative), non-lactation period. 10. Fertile women (WOCBP) subjects had taken effective contraceptive measures 1 month before enrollment. 11. WOCBP subjects and male subjects, who do not plan to become pregnant for 6 months from the screening period to the last dose of immunization, agree to take effective contraceptive measures for 6 months from the screening visit to the last dose of immunization. 12. WOCBP subjects and male subjects agree not to donate eggs (oocytes, oocytes) for assisted reproduction (WOCBP subjects) or to refrain from sperm donation (male subjects) for a period of 6 months from screening visit to the last dose of immunization. 13. Subjects eligible for immunization with this product after medical history, physical examination and clinical judgment of health.
Exclusion criteria
Exclusion criteria: 1. With cancer; Or suffer from other serious chronic diseases, such as asthma without stable control, diabetes, liver and kidney diseases, thyroid diseases, convulsions, epilepsy and other neurological/psychiatric diseases. 2. Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune disease. 3. People who are allergic to any component of the experimental vaccine have had a history of severe vaccine allergic reactions in the past. 4. History of SARS or MERS or SARS-CoV-2 infection/illness within 3 months. 5. People with serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, and severe hypertension that cannot be controlled by drugs. 6. Congenital or acquired angioedema/neuroedema. 7. Urticaria in the year prior to receiving the trial vaccine. 8. Anplenia or functional anplenia. 9. Thrombocytopenia or other clotting disorders (which may contraindicate intramuscular injections). 10. Needle fainter. 11. Immunosuppressive therapy, antiallergic therapy, cytotoxic therapy, inhaled corticosteroids (excluding corticosteroid spray for allergic rhinitis, superficial corticosteroid therapy for acute non-dermatitis) for 14 or more days within 6 months prior to receipt of the experimental vaccine. 12. Received blood products within 3 months prior to receiving the trial vaccine. 13. Received other study drugs within one month prior to receiving the trial vaccine. 14. Received subunit or inactivated vaccine within 14 days or live attenuated vaccine within 1 month prior to receiving the experimental vaccine. 15. Receiving anti-tuberculosis treatment. 16. A variety of medical, psychological, social or other conditions, in the investigator's judgment, were inconsistent with the protocol or affected subjects to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of solicited adverse events (AE) 0-14 days after inoculation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in laboratory tests on day 3 after inoculation;Incidence of unsolicited adverse events (AE) within 30 days after vaccination;Incidence of serious adverse events (SAE), hospitality-requiring adverse events (MAAE), and adverse events of special concern (AESI) within 12 months after vaccination;Geometric mean titer (GMT) of S-RBD protein-specific antibodies (ELISA) against SARS-CoV-2;Geometric mean growth multiple (GMFI) of S-RBD protein specific antibody (ELISA) against SARS-CoV-2;Geometric mean titer (GMT) of neutralizing antibodies against SARS-CoV-2 prototype strain and Omicron variant strain (according to the prevailing strain) ;Geometric mean growth times (GMFI) of neutralizing antibodies against SARS-CoV-2 prototype strain and Omicron variant strain (according to the prevailing strains) ;ELISpot was used to detect the cell frequencies of IFN-? and IL-2 secreted by SARS-CoV-2 S-RBD protein ; | — |
Countries
China
Contacts
Public ContactZhu Fengcai
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Outcome results
None listed