Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Low dose group(18-59 years old):Receive the corresponding dose of RQ3013 or placebo
Low dose group(>= 60 years old):Receive the corresponding dose of RQ3013 or placebo
High dose group(18-59 years old):Receive the corresponding dose of RQ3013 or placebo
High dose group(>= 60 years old):Receive the corresponding dose of RQ3013 or placebo
Sponsors
Jinan Central Hospital; Disease control and prevention center of Shandong Provincial
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged 18-59 and 60 years and older who can provide their own legal identity certificates, both male and female; 2. The subjects understand the contents of the informed consent form and the vaccination, voluntarily sign the informed consent form, and 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 researchers and understand and comply with the requirements of the study; 4. The axillary temperature on the day of vaccination was < 37.3 ?.
Exclusion criteria
Exclusion criteria: Exclusion criteria for the first dose of vaccination Volunteers were excluded from the study if they had any of the following conditions. 1. Those who do not meet the health criteria on comprehensive physical examination, mainly including: (1) those with abnormal vital signs (18-59 years old: waking pulse 100 beats/min, systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg; 60 years old and above: waking pulse 100 beats/min, systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 90 mmHg) and clinically significant; (2) body mass index (BMI) 30 kg/m^2; (3) those whose laboratory test values exceed the upper limit of the normal reference range by a factor of 1.2 or are less than 0.8 times the lower limit during the screening window and are clinically significant as judged by the investigator; 2. History of COVID-19 disease or any COVID-19 prophylaxis (e.g., history of any novel coronavirus vaccination, marketed or unmarketed); 3. Positive SARS-CoV-2 pathogenicity test (RT-PCR test) or positive SARS-CoV-2 IgG/IgM qualitative test; 4. History of previous human coronavirus infection or disease such as SARS or MERS; 5. Fever (axillary temperature >= 37.3°C) on the day of the test vaccination and within the last 72 hours, or the use of antipyretic analgesic drugs within the last 72h; 6. Women with a positive pregnancy test (pregnancy tests are waived for women who have been amenorrheic for at least 1 year or surgically sterilized with medical records), or women who are breastfeeding, or women who plan to become pregnant or plan to interrupt effective contraception, men whose partners plan to become pregnant, or men who plan to donate sperm and eggs from the screening period to 12 months after full immunization; 7. Staff of the clinical trial institution of the study and the sponsor; 8. Prior history of severe metabolic or allergic reactions to vaccines or drugs, e.g., urticaria, severe skin eczema, respiratory distress, laryngeal edema, angioneurotic edema, etc.; 9. Receipt of any vaccine within 28 days prior to the experimental vaccination; 10. Have participated in or are planning to participate in another drug clinical trial within 12 months after the full exemption within 28 days prior to the experimental vaccination; 11. Have a genetic predisposition to bleeding or abnormal coagulation (e.g., cytokine deficiency, coagulation disorder, or thrombocytopenia), or a history of severe bleeding; 12. Have a disease affecting the function of the immune system as confirmed by known medical history or diagnosis, such as cancer (except basal cell carcinoma of the skin), congenital or acquired immunodeficiency (e.g., HIV infection), uncontrolled autoimmune disease, etc.; 13. Absence of spleen or functional absence of spleen; 14. Prolonged use (>= 14 consecutive days) of immunosuppressive or other immunomodulatory drugs (e.g., cortisol hormone: prednisone or equivalent; interferon, etc.) within 6 months prior to experimental vaccination, except that topical administration (e.g., ointment, eye drops, inhaler, or nasal spray) is permitted, and topical administration must not exceed the dose recommended in the instructions; 15. Received immunoglobulin and/or blood products within 3 months prior to the experimental vaccination; 16. Suspected or known alcohol dependence or drug abuse that could affect safety evaluation or affect subject compliance; 17. Pe
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, Qing Wen
Outcome results
None listed