Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
three Groups:High and low dose groups, placebo control
Sponsors
Hunan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Inclusion criteria
Inclusion criteria: 1) Persons with full capacity for civil conduct aged >=60 years; 2) Subjects voluntarily agree to participate in the research and sign an informed consent form, and can provide valid identification; understand and comply with the requirements of the trial protocol; have the ability to understand (non-illiterate) research procedures and participate in the planned follow-up; 3) Axillary body temperature <37.3 Degree C; 4) Female subjects and male subjects of childbearing age agree to take effective contraceptive measures during the study period.
Exclusion criteria
Exclusion criteria: 1) The results of physical examination and laboratory examination before screening are abnormal and clinically significant as judged by clinicians, or systolic blood pressure =160mmHg and/or diastolic blood pressure =100mmHg before screening; 2) A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, blood vessels Neuroedema, etc.; or any previous history of serious side effects after the use of any vaccine or drug; 3) People with a history of SARS and SARS-CoV-2 (meet any of the following: ?Have a history of SARS and SARS-CoV-2 infection or onset; ?During this SRAS-CoV-2 epidemic, there are patients who have been diagnosed with the new crown/ Suspected patient contact history); 4) Have taken antipyretic or analgesic within 24 hours before the first dose of vaccination; 5) Inoculate subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days; 6) People suffering from the following diseases: ? Acute (within 72 hours) feverish illness; ?Suffering from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; ?Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; ?Congenital or acquired immunodeficiency or autoimmune disease history or receiving immunomodulator treatment within 6 months, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc.; but local medication (such as ointment, Eye drops, inhalation or nasal spray); ? Known to have been diagnosed with infectious diseases, such as: tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive; ? Neurological diseases or neurodevelopmental dysfunction (for example, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis; History of mental illness or family history; ?Functional asplenia, as well as any cause of aspleen or splenectomy; ?Severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes and thyroid disease; ?Severe liver and kidney diseases; respiratory diseases that currently require daily drug treatment (for example, chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory diseases (for example, asthma exacerbation) in the last 5 years; suffering from severe History of cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis; ?Have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.; ?Tumor patients; 7) Have received blood or blood-related products, including immunoglobulin, within 3 months; or plan to use it during the research period; 8) Those who are already pregnant (including a positive urine pregnancy test), or are breastfeeding; 9) Any research or unregistered products (drugs, vaccines, biological products or devices) other than research products have been used within 3 months, or planned to be used duri
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 neutralizing antibody;S protein binding antibody (IgG);RBD protein binding antibody (IgG) detection.; | — |
Countries
China
Contacts
Public ContactLi Fangjun
Hu'nan Provincial Center for Disease Control and Prevention
Outcome results
None listed