Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
The vaccine 50 µg group:1 dose of 50 µg test vaccine was administered intramuscularly on days 0 and 28 respectively
The vaccine 100 µg group:1 dose of 100 µg test vaccine was administered intramuscularly on days 0 and 28 respectively
Control group:placebo
Sponsors
Hu'nan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. The age at the time of the first dose of the vaccine is 18-59 years old, and the gender is not limited; 2. The subject has full capacity for civil conduct; 3. Axillary body temperature is less than 37.3 ? on the day of enrollment; 4. Subjects have independent judgment ability, can read, understand and complete vaccination diary cards, and they participate voluntarily and sign an informed consent form.
Exclusion criteria
Exclusion criteria: 1. The subject has contact history with SARS-CoV-2 infected person (positive for nucleic acid test) or suspected infected person within 14 days; 2. Have a history of severe allergy to any vaccine, food or medicine, such as urticaria, anaphylactic shock, eczema, allergic dyspnea, angiopathic edema, etc.; 3. Subjects have a history of allergy to any of the components of the study vaccine (SARS-CoV-2 mRNA, Dlin-MC3-DMA, cholesterol, distearyl phosphatidylcholine, PEG2000-DMG, phosphoric acid buffer); 4. Have a history of SARS virus infection; 5. Subjects with medical history or family history of epileptic convulsions, nervous system diseases and mental diseases; 6. A history of hospital-diagnosed thrombocytopenia or other coagulation disorders before enrollment; 7. The researchers judged known or suspected co-occurrence of more severe diseases, including: Respiratory disease, tuberculosis, acute infection or chronic disease activity, liver and kidney disease, cardiovascular disease (cardiopulmonary failure), drug-uncontrolled hypertension (systolic blood pressure >=160mmHg, diastolic blood pressure >= 100mmHg), malignant tumor, infection or allergic skin disease, HIV infection (test report can be provided); 8. Congenital malformation, developmental disorders, or chronic diseases (such as Down syndrome, diabetes mellitus, sickle cell anemia or neurological disorders, Guillain-Barre syndrome) that the researchers have determined are not suitable for participation in this study; 9. Subjects with known impairment or low immunological function diagnosed by the hospital before enrollment; 10. Evidence of tobacco, alcohol and drug abusers; 11. Positive SARS-CoV-2 nucleic acid test and/or positive antibody test before the first dose of vaccine; 12. Female: those who have a positive urine pregnancy test, are pregnant, breastfeeding, or have a pregnancy plan within 1 year; Male: whose spouse plans to become pregnant within 1 year; 13. Using any other investigational or unregistered product (drug, biological product or device) prior to the first dose of the vaccine, or planning to use it during the study; 14. Subjects receiving immunoenhancement or immunosuppressive therapy within 6 months prior to the first dose of vaccine (continuous oral or intravenous infusion for more than 14 days); 15. Have been diagnosed with congenital or acquired immunodeficiency or suspected systemic diseases that may interfere with the conduct or completion of the study, such as tuberculosis, hepatitis B, hepatitis C, human immunodeficiency virus (HIV), syphilis infection, etc.; 16. Those who received whole blood, plasma and immunoglobulin treatment in the six months prior to the first dose of vaccine; 17. Other inactivated vaccines were administered within 14 days and live attenuated vaccines within 28 days prior to the first dose; 18. Taking antipyretic, analgesic and antiallergic drugs within 3 days prior to enrollment; 19. 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; 20. Relevant staff members participating in the study themselves or their immediate family members (e.g. spouse, parents, siblings or children); 21. In the investigator's judgment, there are other conditions that are not appropriate for participation in this clinical
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Levels of SARS-CoV-2 novel coronavirus S protein antibody (IgG);Levels of SARS-CoV-2 novel coronavirus neutralizing antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse events;Positive conversion rate of SARS-CoV-2 S protein antibody;Positive conversion rate of SARS-CoV-2 neutralizing antibodies;Level of specific cellular immune response against novel coronavirus (2019-nCoV); | — |
Countries
China
Contacts
Public ContactHuang Tao
Outcome results
None listed