Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Group A1:Low dose COVID-19 mRNA vaccine
Group A2:High dose COVID-19 mRNA vaccine
Group A3:COVID-19 inactivated vaccine
Group B1:Low dose COVID-19 mRNA vaccine
Group B2:High dose COVID-19 mRNA vaccine
Group B3:COVID-19 inactivated vaccine
Group C1:High dose COVID-19 mRNA vaccine
Group C2:None
Sponsors
Shanghai East Hospital of Tongji University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Chinese citizens aged 18 to 59 years or aged >=60 years who can provide legal identity; 2. Healthy adults or adults with pre-existing medical conditions have stable medical conditions. Stable health status was defined as deterioration of the disease that did not require significant intensification of treatment or hospitalization during the 3 months prior to enrollment and deterioration of the disease that did not require additional treatment or hospitalization in the foreseeable future; 3. Patients who have recovered from COVID-19 after receiving 2 or 3 doses of inactivated COVID-19 vaccine and have been released from isolation or discharged from hospital for no less than 7 days (An additional group of patients who were not vaccinated against COVID-19 was set up in the >=60 age group); 4. Patients with the ability to understand the research procedures, voluntarily sign informed consent after informed consent, and comply with the requirements of clinical research protocols.
Exclusion criteria
Exclusion criteria: 1. Acute illness or fever 72 hours before or at the time of screening. Fever is defined as body temperature >=37.3? (axillary temperature). Subjects who meet this criteria may be rescheduled during the relevant window period. Febrile subjects with minor illnesses may be enrolled at the discretion of the investigator; 2. Subjects who were pregnant when enrolled or planned to become pregnant within the first 3 months after vaccination; 3. Known or suspected allergy or history of anaphylaxis, urticaria, or other significant adverse reactions to vaccines or their excipients; 4. Hemorrhagic disease that is considered contraindicated for intramuscular injection; 5. Received or planned to receive a non-study vaccine within 28 days before or after any study vaccine (except for seasonal influenza vaccine, which is not allowed within 14 days before or after any study vaccine); 6. Participated in interventional clinical studies within 28 days before the enrollment day; 7. Immunosuppressed or immunodeficient status, no spleen, recurrent severe infection (HIV-positive subjects with CD4 count >=350 cells /mm^3 and no detectable HIV viral load within the past year [allow low level changes of between 50 and 500 viral copies that do not result in changes in ART]); 8. Subjects with uncontrolled epilepsy and other serious neurological disorders (e.g. Transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.); 9. Abnormal patients with clinical significance in blood biochemistry, blood routine, urine routine, coagulation function and myocarditis related indexes detected before inoculation; 10. Received >14 days of systemic immunosuppressant or immunomodulatory drugs (>=20 mg/ day equivalent of prednisone for corticosteroids) in the 6 months prior to screening; 11. Received systemic immunoglobulin or blood product treatment in the 3 months prior to screening; 12. Blood donation >=450 mL within 28 days prior to screening.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Spike protein binding antibody titer;Pseudovirus neutralization antibody titer;Live virus neutralization antibody titer; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cellular immune response;Local adverse effect;Systemic adverse effect; | — |
Countries
China
Contacts
Public ContactLiu Zhongmin
Outcome results
None listed