Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group 1 (18-59 years old group):SARS-CoV-2mRNA Vaccine 15ug/0.5ml
Control group (18-59 years old group):COVID-19 Vaccine (Vero Cell), Inactivated
Experimental group (60 years old and above group):SARS-CoV-2mRNA Vaccine 15ug/0.5ml
Control group (60 years old and above group):COVID-19 Vaccine (Vero Cell), Inactivated
Sponsors
Walvax Biotechnology Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-59 years or aged 60 and above who can provide legal identification, no gender limit; 2. Subjects should understand the content of the informed consent form and the vaccines vaccinated this time, voluntarily sign the informed consent form, and have the ability to use a thermometer, a 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 this research; 4. For female subjects: no reproductive potential (including amenorrhea for at least 1 year or surgical sterilization with medical records) or have used effective contraceptive measures within 2 weeks before being enrolled in this study, and the pregnancy test is negative; the subjects voluntarily agree to continue using effective contraceptive measures with their partners within 6 months after the completion of the vaccination. Effective contraception includes: abstinence or adequate contraception [eg, intrauterine or implantable contraceptive devices, oral contraceptives, injectable or implanted contraception, sustained-release local contraceptives, condoms (for men), diaphragms, cervical caps, etc.]; 5. Healthy subjects or subjects with mild underlying diseases [at least 3 months before enrollment in this study in a stable state with no aggravation (no need for hospitalization or major adjustment of treatment plan, etc.)]; 6. 2 doses of Kexing's new coronavirus inactivated vaccine have been vaccinated for 6 months before enrollment, and the interval between 2 doses of new coronavirus inactivated vaccine is 21 to 56 days.
Exclusion criteria
Exclusion criteria: 1. History of COVID-19 or use of any COVID-19 preventive medicine except 2 doses of Kexings novel coronavirus inactivated vaccine (For example, the vaccination history of any other non-Kexing 2019-nCoV inactivated vaccine that has been listed or not listed, or the vaccination history of more than 2 doses of Kexing 2019-nCoV inactivated vaccine); 2. Abnormal blood pressure and pulse test results during the screening period (18-59 years old: awake pulse 100 beats/min, systolic blood pressure >= 140 mmHg or diastolic blood pressure >= 90 mmHg; ages 60 and above: awake state pulse 100 beats/min, systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 90 mmHg) and judged by the investigator to have clinical significance; 3. Positive for SARS-CoV-2 etiological test (RT-PCR test); 4. There is a history of SARS, MERS and other coronavirus infection or disease history; 5. Fever (axillary temperature >=37.3°C) on the day of vaccination and within the last 72 hours; 6. Breastfeeding; 7. Staff of the research institution and sponsor of this trial; 8. History of severe allergic or allergic reactions to vaccines or drugs, such as urticaria, severe skin eczema, dyspnea, laryngeal edema, angioedema, etc.; 9. Any vaccine within 28 days before the experimental vaccine; 10. Those who have participated in the clinical trials of other drugs within 28 days before vaccination or plan to participate in other drug clinical trials within 12 months after the vaccination; 11. Has hereditary bleeding tendency or abnormal coagulation function (for example: cytokine deficiency, coagulation disorder or thrombocytopenia), or has a history of severe bleeding; 12. According to known medical history or diagnosis, it is confirmed to have a disease that affects the function of the immune system, such as cancer (except basal cell carcinoma of the skin), congenital or acquired immune deficiency (eg: HIV infection), uncontrolled autoimmune disease, etc. ; 13. Asplenia or functional asplenia; 14. Long-term use (>=14 days of continuous use) of immunosuppressive drugs or other immunomodulatory drugs (such as cortisol hormones: prednisone or similar drugs; interferon, etc.) within 6 months before the experimental vaccine, however, topical medication (such as ointment, eye drops, inhalation or nasal spray) is allowed, and topical medication should not exceed the dose recommended in the instructions; 15. Received immunoglobulin and/or blood products within 3 months before the experimental vaccine; 16. Suspected or known alcohol dependence or drug abuse, which may affect safety evaluation or affect subject compliance; 17. Plan to permanently relocate from the region before the end of the study or to leave the region for a long time during the study visit; 18. Other factors deemed inappropriate by the investigator to participate in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Euvirus neutralizing antibodies; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pseudovirus neutralizing antibody;IgG antibody; | — |
Countries
China
Contacts
Public ContactYuan Lin
Outcome results
None listed