COIVID-19 infection
Conditions
Interventions
Group 1 :Investigational vaccine or control vaccine of corresponding dose
Group 2:Investigational vaccine or control vaccine of corresponding dose
Group 3:Investigational vaccine or control vaccine of corresponding dose
Sponsors
Zhongshan Hospital Affiliated to Fudan University
Eligibility
Sex/Gender
All
Age
No minimum to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age = 50 kg, female >= 45 kg; Body mass index (BMI) within 18-30 kg/m2 (including 18 and 30); 3. No dysfunction of major organs, normal heart, liver and kidney function, and stable control of chronic diseases (such as well-controlled hypertension, hyperlipidemia, diabetes, etc.); 4. Comprehensive physical examination (vital signs, physical examination), routine laboratory tests (blood routine, blood biochemistry, urine routine, coagulation function), 12-lead electrocardiogram, chest X-ray and other examination results are normal or abnormal, but the researcher It is determined that it is related to age and chronic diseases, and the safety risk of the subjects after enrollment is low, and does not affect the research observation indicators; 5. Negative COVID-19 nucleic acid PCR test before screening; 6. Negative COVID-19 antibody test before screening; 7. Those who understand the research procedures and methods, voluntarily participate in this study, and sign the informed consent form in writing.
Exclusion criteria
Exclusion criteria: 1. The subject has a history of SARS virus infection, or a history of SARS-CoV-2 infection, or close contact with a SARS-CoV-2 infection (nucleic acid test positive), or a history of travel abroad in the 30 days before screening; 2. Previous history of allergies to acetaminophen or vaccination (e.g., acute allergic reactions, urticaria, dyspnea, angioedema or abdominal pain); 3. Have not received 2 doses of inactivated COVID-19 vaccine or the 2nd dose of COVID-19 vaccine for less than 6 months before screening, have received other inactivated vaccines within 7 days before screening, and have received live attenuated vaccines within 14 days; 4. Those who have a history or family history of epilepsy or convulsions, neurological diseases and psychiatric diseases; 5. Contraindications to intramuscular injection, such as: diagnosed thrombocytopenia, any coagulation disorders, or anticoagulant therapy; 6. The researcher determines that he or she has a known or suspected serious disease, including but not limited to: respiratory disease (lung failure, etc.), liver and kidney disease, cardiovascular disease (heart failure, severe hypertension, etc.), malignant tumor, infectious or allergic skin disease, HIV infection (test report can be provided), or during the active period of acute infection or chronic disease (within 3 days before vaccination); 7. Women of childbearing age: those who have a positive urine pregnancy test before vaccination, who are pregnant, breastfeeding, or have a pregnancy plan within 1 year; male: those whose spouse of childbearing age has a pregnancy plan within 1 year; 8. Those who are participating or planning to participate in other clinical trials during the study period; 9. Those who have received immune enhancement or immunosuppressive therapy within 3 months (continuous oral or instillation for more than 14 days); or those who have received whole blood, plasma and immunoglobulin therapy within 1 month; 10. The investigator determines that there are other circumstances that are not suitable for participating in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events within 30 days after vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| Titers of IgG in serum before and after vaccination; | — |
Countries
China
Contacts
Public ContactJia Fan
Zhongshan Hospital Affiliated to Fudan University
Outcome results
None listed