Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
18-59 years old test group:Inoculate with test vaccine
18-59 years old control group:Inoculate with placebo
= 60 years old test group:Inoculate with test vaccine
>= 60 years old control group:Inoculate with placebo
Sponsors
Disease control and prevention center of Shandong Provincial
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) Healthy adults aged 18-59, 60 years old and above who can provide their own legal identity certificate, both male and female; (2) The subject understands the content of the informed consent form and the vaccine situation of this vaccination, voluntarily agrees and the informed consent form is signed by the subject himself or his fair witness. The subject himself or his family members have the ability to use the thermometer, scale and fill in the diary card and contact card as required; (3) Be able to communicate well with investigators, and understand and comply with the requirements of this study; (4) The axillary temperature on the day of inoculation was less than 37.3 degree.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose of inoculation Subjects meeting any of the following exclusion criteria shall not be included in the study: (1) Those with abnormal vital signs (pulse and blood pressure)and clinical significance (18-59 years old: pulse100 times/min, systolic pressure>=140mmHg or diastolic pressure>=90mmHg in awake state; 60 years old and above: pulse100 times/min, systolic pressure>=150mmHg or diastolic pressure>=90mmHg in awake state (60 years old or above, if the systolic pressure is >= 150mm Hg or the diastolic pressure is>=90mmHg, but the systolic pressure is=37.3 degree) in the last 72 hours before the vaccination of experimental vaccine, or antipyretic analgesic and anti allergic drugs used in the last 72 hours; (6) Women with positive pregnancy test (pregnancy test can be exempted for those with amenorrhea for at least one year or surgical sterilization with medical records), or women in lactation period, or women who plan to become pregnant or plan to discontinue effective contraceptive measures within 12 months from the screening period to the full course of immunization, or men whose partners plan to become pregnant, or those who plan to donate sperm and eggs; (7) Staff of the study institution and sponsor of this study; (8) Have a history of severe allergy or anaphylaxis to vaccines or drugs in the past, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioneurotic edema, etc; (9) Inoculate any vaccine within 28 days before the investigational vaccine inoculation; (10) Have participated in the clinical study of other drugs within 28 days before the vaccination of the investigational vaccine or plan to participate in the clinical trials of other products within 12 months after the full vaccination; (11) Hereditary bleeding tendency or coagulation dysfunction (such as cytokine defect, coagulation disorder or thrombocytopenia), or severe bleeding history; (12) According to the known medical history or diagnosis, the patient is confirmed to have diseases that affect the function of the immune system, such as cancer (except skin basal cell carcinoma), congenital or acquired immunodeficiency (such as HIV infection), uncontrollable autoimmune diseases, etc; (13) Absence of spleen or functional absence of spleen; (14) Long term use of immunosuppressants or other immunomodulatory drugs (such as cortisol hormone: prednisone or similar drugs; interferon, etc.) within 6 months before vaccination (continuous use more than 14 days), but local drug use (such as ointment, eye drops, inhalants or nasal sprays) is allowed, and the local drug use shall not exceed the dose recommended in the instructions; (15) Have received immunoglobulin and/or blood products within 3 months
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live virus neutralizing antibody titers against SARS-CoV-2 current major endemic strain; | — |
Secondary
| Measure | Time frame |
|---|---|
| Live virus neutralizing antibody titers against SARS-CoV-2 Beta strain and the current major endemic strain;S protein specific IgG antibody titer;Specific cellular immunity; | — |
Countries
China
Contacts
Public ContactLi Zhang
Disease control and prevention center of Shandong Provincial
Outcome results
None listed