Healthy susceptible people
Conditions
Interventions
experimental group:mRNA vaccine
Sponsors
Shanghai Dongfang Hospital (Dongfang Affiliated Hospital of Tongji University)
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Chinese aged between 18 and 60 who can provide legal identification; 2. According to the medical history and physical examination, the patient was determined to be healthy by the investigator (Excluding the following conditions: known or suspected to have a more serious disease including respiratory disease, acute infection or chronic disease active stage, liver and kidney disease, malignant tumor, infectious or allergic skin disease, HIV infection (test report can be provided); 3. Serious cardiovascular disease diagnosed in hospital (cardiopulmonary failure, hypertension that cannot be controlled by drugs (physical examination systolic blood pressure >= 140mmHg and/or diastolic blood pressure >= 90mmHg); 4. Have not been to any village/community that has been infected with novel Coronavirus or suspected cases in the past 2 months, have not been in contact with persons who are not in quarantine period, and have not been infected with novel Coronavirus or suspected cases in the same village/community; 5. Have the ability to understand the study procedures, have informed consent, voluntarily signed informed consent, and can comply with the requirements of the clinical trial protocol.
Exclusion criteria
Exclusion criteria: 1. Novel coronavirus antibody was positive, and novel coronavirus nucleic acid was positive; 2. A history of SARS/MERS virus infection (self-report, on-site inquiry); 3. People who have been in contact with a confirmed novel coronavirus case or a suspected case within one month; 4. Have received other Novel Coronavirus vaccines; 5. People with a history of allergy to phenolamine; 6. Women with positive HCG test, who are pregnant or lactating, or who plan to become pregnant within 13 months; 7. People with a history or family history of allergies, convulsions, epilepsy, encephalopathy and mental illness; 8. Previous allergic history of any drug or vaccine vaccination (such as acute allergic reaction, urticaria, skin eczema, dyspnea, angioneurotic edema, or abdominal pain) or allergy to known components of Novel Coronavirus vaccine; 9. A history of thrombocytopenia or other coagulation disorders diagnosed in the hospital; 10. Patients with known immunological impairment or low function diagnosed by hospital; 11. Patients who received whole blood, plasma and immunoglobulin treatment within 3 months; 12. Abnormal subjects with clinical significance to detect relevant indexes of blood biochemical, blood routine and urine routine before inoculation; 13. Fever (armpit temperature > 37.3 degree C), dry cough, fatigue, nasal congestion, runny nose, sore throat, myalgia, diarrhea, tachypnea, dyspnea within 14 days before inoculation; 14. Have received live attenuated vaccine within one month before vaccination and other vaccines within 14 days before vaccination; 15. Armpit body temperature > at inoculation was 37.3 degree C; 16. considered by the investigator to be associated with vaccination.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Security Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| Immunogenicity indicators; | — |
Countries
China
Contacts
Public ContactLiu Zhongmin
Shanghai Dongfang Hospital (Dongfang Affiliated Hospital of Tongji University)
Outcome results
None listed