Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Two cohorts:Test vaccine and placebo control
Sponsors
Hunan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. People who are 18 years old and above; 2. The subjects themselves voluntarily participate in the study, sign an informed consent form, and can provide valid identification, understand and comply with the requirements of the trial protocol; 3. Female subjects of childbearing age agree to take effective contraceptive measures from the beginning of the study to 2 months after the full vaccination.
Exclusion criteria
Exclusion criteria: 1. Fever is suspected or diagnosed within 72 hours before enrollment (axillary temperature >=37.3 degree C/oral temperature >=37.5 degree C), or underarm body temperature >=37.3 degree C/oral temperature >=37.5 degree C on the day of enrollment; 2. Diastolic blood pressure >=100mmHg and/or systolic blood pressure .=150mmHg; 3. Those with a history of COVID-19; 4. One of the SARS-COV-2 nucleic acid and antibody tests is positive (In Indonesia, one of the SARS-COV-2 antigen and antibody tests); 5. People who currently suffer from the following diseases: (1) Having thrombocytopenia, any coagulation dysfunction or receiving anticoagulant treatment, etc.; (2) History of congenital or acquired immunodeficiency or autoimmune disease; as well as no spleen, or history of splenic surgery, history of trauma or within 6 months Receive immunomodulator therapy, such as: immunosuppressant dose of glucocorticoid (dose reference: equivalent to prednisone 20mg/day, more than one week); or monoclonal antibody; or thymosin; or interferon, etc.; but local medication is allowed ( Such as ointment, eye drops, inhalation or nasal spray); (3) related symptoms of acute respiratory infection (such as: sneezing, nasal congestion, runny nose, cough, sore throat, decreased taste, chills, shortness of breath, etc.); (4) cancer patients (Except for basal cell carcinoma); Past history of severe allergies to any vaccine, or history of severe allergies to any component of the test vaccine, including aluminum preparations, 6) For example: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis Reaction (Arthus reaction), dyspnea, angioedema, etc.; 7. Inoculate subunit vaccine and inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days; 8. Have received blood or blood-related products, including immunoglobulins, within 3 months; or plan to use them from the beginning of the study to 6 months after the full vaccination; 9. Have participated in or are participating in other COVID-19 related clinical trials; 10. Lactating or pregnant women (including those who have a positive urine pregnancy test for women of childbearing age); 11. The investigator believes that any disease or condition in the subject may put the subject at an unacceptable risk; the subject cannot meet the requirements of the protocol; the situation that interferes with the assessment of the vaccine response.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 neutralizing antibody;RBD protein binding antibody (IgG) detection.; | — |
Countries
China
Contacts
Public ContactLi Fangjun
Hunan Provincial Center for Disease Control and Prevention
Outcome results
None listed