SARS-CoV-2 (COVID-19)
Conditions
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 59 years; 2. Subjects with armpit body temperature < 37.3? on the day of enrollment; 3. Based on medical history and relevant physical examination and laboratory examination results (normal or abnormal without clinical significance), the investigator clinically determines that the body is qualified; 4. The subjects have independent judgment ability, participate voluntarily and sign informed consent.
Exclusion criteria
Exclusion criteria: 1. The subjects have a history of SARS virus infection, or SARS-CoV-2 infection, or close contact with SARS-CoV-2 infected persons (nucleic acid test positive), or travel abroad within 30 days before screening; 2. Positive antibody test for SARS-CoV-2; 3. A history of allergic reactions to acetaminophen or vaccination (e.g. acute allergic reactions, hives, dyspnea, angioneurotic edema, or abdominal pain); 4. Have a history of COVID-19 vaccination, or have received other inactivated or recombinant vaccines within 7 days and live attenuated vaccines within 14 days before the first dose; 5. Medical history or family history of epilepsy or convulsions, neurological diseases and mental diseases; 6. There are contraindications to intramuscular injection, such as diagnosed thrombocytopenia, any clotting disorders, or treatment with anticoagulants; 7. The investigator judged to have known or suspected serious medical conditions, including but not limited to: respiratory diseases (lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart failure, severe hypertension, etc.), malignancies, infectious or allergic skin diseases, HIV infection, or during acute infection or chronic disease activity (within 3 days prior to vaccination); 8. Chronic diseases (such as Down's syndrome, sickle cell anemia or neurological disorders, Guillain-Barre syndrome, etc., excluding diabetes/hypertension with stable control) that the researchers determined were not suitable for participation in the study; 9. Subjects with known impairment or low immunological function diagnosed by hospital prior to enrollment, or functional anplenectomy or splenectomy due to any condition; 10. Women of childbearing age: those who tested positive for pregnancy before the first dose of vaccination, are pregnant, breastfeeding, or plan to become pregnant within 1 year; Male: the spouse of the childbearing age has planned to become pregnant within 1 year; 11. Participating in other clinical trials during the study period or planning to do so; 12. Those who received immunoenhanced or immunosuppressive therapy within 3 months (continuous oral or intravenous infusion for more than 14 days); Or have received whole blood, plasma and immunoglobulin treatment within 1 month; 13. Subjects who, in the investigator's judgment, are unable to comply with study procedures, follow protocol, or plan to permanently relocate from the area prior to the end of the study, or plan to leave the area for an extended period of time during the scheduled visit; Or other conditions that are not suitable for participation in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| adverse events;adverse events associated with experimental vaccines; | — |
Secondary
| Measure | Time frame |
|---|---|
| Geometric mean titer (GMT), geometric mean fold increase (GMI), and seroconversion rate (SCR) of anti-SARS-CoV-2 antibodies (specific IgG antibody, neutralizing antibody) ;adverse events associated with laboratory tests;serious adverse events (SAE);adverse events of special interest (AESI); | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed