SARS-CoV-2 infection
Conditions
Interventions
Group A:Group A
Group B:Group B
Sponsors
Shanghai Xuhui Central Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Group A must meet all of the following conditions to receive the trial vaccination: 1. Age = 50 kg, female >= 45 kg; body mass index (BMI) within the range of 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 examination (blood routine, blood biochemistry, urine routine), 12-lead ECG, chest x-ray are normal or abnormal, but the researcher determines that it is related to age and chronic disease; 5. Negative SARS-CoV-2 test for two times within 48 hours before screening; 6. Received 3 doses of inactivated COVID-19 vaccine before screening; 7. Subjects who understand the research procedures and methods, voluntarily participate in this research, and sign an informed consent form. Group B must meet all of the following conditions to receive the trial vaccination: 1. Age < 70 years old, male or female; 2. Negative SARS-CoV-2 test for two times within 48 hours before screening; 3. Confirmed SARS-CoV-2 infection within 4 weeks before screening, and has recovered; 4. Subjects who understand the research procedures and methods, voluntarily participate in this research, and sign an informed consent form in writing.
Exclusion criteria
Exclusion criteria: Group A subjects who met any of the following criteria were excluded from the study: 1. Subjects have a history of SARS virus or SARS-CoV-2 infection, or a close contact with a SARS-CoV-2 infected person (a person with a positive nucleic acid test), or a history of travel abroad within 30 days before screening; 2. History of allergy to acetaminophen or vaccination (such as acute allergic reactions, urticaria, dyspnea, angioedema or abdominal pain); 3. Vaccinated against SARS-CoV-2 within 6 months before screening; vaccinated with other inactivated vaccines within 7 days before screening; or vaccinated with live attenuated vaccines within 14 days; 4. History or family history of epilepsy or convulsions, neurological diseases and mental illnesses; 5. Contraindications to intramuscular injection; 6. Known or suspected serious diseases, including but not limited to: respiratory diseases (lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart failure, severe hypertension, etc.), malignant tumors, infectious or allergic skin diseases, HIV infection, or active period of acute infection or chronic disease; 7. Women of childbearing age: positive for the urine pregnancy test before vaccination, pregnant, breastfeeding, or have a pregnancy plan within 1 year; male: their parental age spouse has a pregnancy plan within 1 year; 8. Subjects who are participating or planning to participate in other clinical trials during the study period; 9. Subjects who have received immune enhancement or immunosuppressive therapy within 3 months; or have received whole blood, plasma and immunoglobulin therapy within 1 month; 10. Other conditions that are not suitable for participating in this clinical trial determined by the investigators. Group B subjects who met any of the following criteria were excluded from this study: 1. Vaccinated against SARS-CoV-2 within 6 months before screening; vaccinated with other inactivated vaccines within 7 days before screening; or vaccinated with live attenuated vaccines within 14 days; 2. Subjects who are participating or planning to participate in other clinical trials during the study period; 3. Other conditions that are not suitable for participating in this clinical trial determined by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Titers (or activity) of specific IgG antibodies against novel Coronavirus (Omicron, Delta and original Strains);Pseudovirus neutralizing titer;Cellular immune response (IFN-?); | — |
Countries
China
Contacts
Public ContactJingying Jia, Gangyi Liu
Outcome results
None listed