Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Adult low-dose group:Investigational vaccine or placebo of corresponding dose
Elderly low-dose group:Investigational vaccine or placebo of corresponding dose
Adult medium-dose group:Investigational vaccine or placebo of corresponding dose
Elderly medium-dose group:Investigational vaccine or placebo of corresponding dose
Adult high-dose group:Investigational vaccine or placebo of corresponding dose
Elderly high-dose group:Investigational vaccine or placebo of corresponding dose
Sponsors
Shulan (Hangzhou) Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1.Age at the time of the first dose of vaccine: aged 18 to 59 years (including boundary values) in the adult group, >=60 years old in the older group, regardless of gender; 2.Axillary body temperature is less than 37.3 ? on the day of enrollment; 3.Based on the medical history and relevant physical examination and laboratory examination results, the investigator clinically determined that the patient was in good health; 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 a history of SARS-CoV-2 infection, or has a history of contact with SARS-CoV-2 infected persons (nucleic acid test positive) or suspected infected persons within 30 days before screening, or living abroad within 30 days before screening history; 2.Anyone who is allergic to any vaccines, drugs, foods or known excipients (Dlin-MC3-DMA, cholesterol, distearoylphosphatidylcholine, PEG2000-DMG); 3.Have a history of SARS virus infection; 4.Upon questioning, have a history of COVID-19 vaccination, or have received other inactivated vaccines within 14 days before screening, and received live attenuated vaccines within 28 days; 5.Patients have a medical history or family history of epilepsy, convulsions or convulsions, neurological diseases and mental diseases; 6.There are contraindications for intramuscular injection, such as: thrombocytopenia that has been diagnosed, any coagulation disorder or receiving anticoagulant treatment, etc.; 7.The investigator judges that he is known or suspected of having more serious diseases at the same time, including but not limited to: respiratory diseases (tuberculosis, lung failure, etc.), liver and kidney diseases, cardiovascular diseases (heart failure, severe hypertension, etc.), Malignant tumor, infection or allergic skin disease, HIV infection (test report can be provided), or during the active period of acute infection or chronic disease (within 3 days before vaccination); 8.Congenital malformations, developmental disorders, or chronic diseases that the investigator judges are not suitable for participating in this study (such as Downs syndrome, sickle cell anemia or neurological disorders, Guillain-Barre syndrome, etc.), excluding stable diabetes/hypertension ); 9.Patients with known immunological impairment or low immunological function diagnosed by the hospital before enrollment, or functional aspleen or splenectomy caused by any situation; 10.There is evidence that they are smokers (smokers >=10 cigarettes/day), alcoholics (alcohol consumption >=4 units/day), drug abusers, and those who do not agree to quit smoking or drinking during the trial; 11.Positive SARS-CoV-2 nucleic acid test and/or positive antibody test before the first dose of vaccine, and/or abnormal imaging examination (small patchy shadow and interstitial change, obvious peripheral lung zone, ground-glass shadow, infiltrating shadow, lung consolidation, etc.), and/or decreased lymphocyte count; 12.Female: those who have a positive blood pregnancy test, are pregnant, breastfeeding, or have a pregnancy plan within one year; men: whose spouse has a pregnancy plan within one year; 13.Patients have participated in other clinical trials (drugs, biological products or devices) within 3 months before the first dose of vaccine, or plan to participate in other clinical trials during the research period; 14.Patients received immune enhancement or immunosuppressive therapy within 6 months before the first dose of vaccine (continuous oral or instillation for more than 14 days); 15.Patients donated blood >=400 ml within 28 days before screening, or received whole blood, plasma and immunoglobulin therapy within 6 months before screening; 16.Currently receiving research drug treatment to prevent COVID-19; 17.Patients are taking antipyretic, analgesic and anti-allergic drugs within 3 days before enrollment; 18.The investigator judges that the subjects cannot follow the research procedures, comply with the agreement,
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events;Incidence of adverse events associated with the experimental vaccine; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of >= grade 3 adverse events;Incidence of >= grade 3 adverse events associated with the trial vaccine;Incidence of serious adverse reactions;Withdrawal from the trial due to adverse events;Incidence of serious adverse events associated with the experimental vaccine;Incidence of clinically significant abnormalities in laboratory test indicators after vaccination; | — |
Countries
China
Contacts
Public ContactChen Guiling
Shulan (Hangzhou) Hospital
Outcome results
None listed