COVID-19
Conditions
Interventions
Experimental group 1:Recombinant COVID-19(XBB)Trimer Protein Vaccine(Sf9 Cell)(WSK-V102D)
Experimental group 2:Eecombinant variant COVID-19 vaccine (Sf9 cell) (WSK-V102)
Sponsors
Jiangsu Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18 years and above, including those with underlying diseases or immunocompromised subjects; 2. Completed basic or booster immunization with COVID-19 vaccine >= 3 months; 3. No infection history of SARS-CoV-2 within 3 months, or never infected; 4. Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.
Exclusion criteria
Exclusion criteria: 1. Axillary temperature >= 37.3?; 2. SARS-CoV-2 antigen or nucleic acid screening positive during the screening period; 3. Anti-SARS-CoV-2 IgM antibody was positive during the screening period; 4. It is in the advanced stage of malignant tumor and the disease control is unstable; 5. Female pregnancy (pregnancy test results are positive), lactation period; 6. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure and so on, severe hypertension, and can not be controlled by drugs; 7. Have other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions; 8. Have been diagnosed with congenital or acquired immunodeficiency, HIV infection(Including screening Anti-HIV antibody test positive); 9. People who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past; 10. Congenital or acquired angioedema/neuroedema; 11. Asplenia or functional asplenia; 12. Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications); 13. Received another investigational drug within 1 month prior to receiving the investigational vaccine; 14. Received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month; 15. Fertile female subjects did not use effective contraception within 1 month prior to enrollment; 16. Fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization; 17. Medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent. Note: Previous infection of SARS-CoV-2 in this study is defined as: if the subjects' previous nucleic acid or antigen test results are positive, they can be determined as previous COVID-19 infection according to the test results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Case of the first occurrence of a etiological confirmed (SARS-CoV-2 antigen or PCR positive) of symptomatic COVID-19, regardless of severity, >14 days-6 months after booster immunization.;Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after booster immunization.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Case of the first occurrence of etiological confirmed (SARS-CoV-2 antigen or PCR positive) of moderate/severe COVID-19 caused by SARS-CoV-2 infection, cases of hospitalization due to COVID-19, and cases of death due to COVID-19, > 7 days-6 months and >14 days-6 months after booster immunization;Case of the first occurrence of a etiological confirmed (SARS-CoV-2 antigen or PCR positive) of symptomatic COVID-19, regardless of severity, >7 days-6 months after booster immunization.;Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days after booster immunization.;Incidence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after booster immunization.;The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies against SARS-CoV-2 variants and the current variants at same time on day 7,14, 30 and 3, 6 months after booster immunization.;The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of IgG against SARS-CoV-2 S-RBD protein on day 7,14, 30 and 3, 6 months after booster immunization.; | — |
Countries
China
Contacts
Public ContactFengcai Zhu
Jiangsu Provincial Center for Disease Control and Prevention (Jiangsu Institute of Public Health)
Outcome results
None listed