Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:V-01 Bivalent Vaccine(V-01-351/V-01D)
Sponsors
The Third People's Hospital of Shenzhen
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Subjects aged 18-59 years who can provide legal identification, no gender limit; 2. Subjects who understand the contents of the informed consent form and the vaccine being administered, voluntarily sign the informed consent form, and have the ability to use a thermometer and to complete the diary and contact cards as required; 3. Be able to communicate well with the investigator and to understand and comply with the requirements of the study; 4. For female subjects: pregnancy test prior to enrollment in this study is negative; subjects voluntarily agree to continue using effective contraception with their partner for 6 months after completion of vaccination. Effective contraception includes: abstinence or adequate contraception [e.g., intrauterine or implantable devices, oral contraceptives, injectable or implantable contraception, extended-release topical contraceptives, condoms (male), 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 or 3 doses of inactivated novel coronavirus vaccinated for 6 months or more prior to enrolment, with an interval of 21-56 days between 2 consecutive doses of inactivated novel coronavirus vaccine.
Exclusion criteria
Exclusion criteria: 1. History of COVID-19 or use of any COVID-19 preventive medicine other than 2-3 doses of inactivated novel coronavirus vaccine (e.g., history of vaccination with any other non-novel coronavirus inactivated vaccine, marketed or not, or 3 history of inactivated vaccine against novel coronavirus above doses); 2. Acute exacerbation of chronic rhinitis, previous history of chronic rhinitis or history of nasal surgery; 3. Symptoms related to acute respiratory infection (such as sneezing, nasal congestion, runny nose, cough, sore throat, loss of taste, chills, shortness of breath, etc.); 4. A previous history of asthma; 5. Abnormal blood pressure and pulse test results during the screening period (18-59 years old: awake state pulse 100 beats/min, systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg), and judged by the investigator to have clinical significance; 6. Positive SARS-CoV-2 etiological test (RT-PCR test); 7. Previous history of SARS, MERS and other coronavirus infection or disease history; 8. Fever (axillary temperature >=37.3 ?) on the day of vaccination and within the last 72 hours; 9. Lactating subjects; 10. This trial specifically involves clinical researchers and sponsor staff; 11. Previous history of severe allergic reaction or allergic reaction to vaccines or drugs, such as urticaria, severe eczema, dyspnea, laryngeal edema, angioneurotic edema, etc.; 12. Administer any vaccine within 28 days before the trial vaccine is administered; 13. Have participated in other drug clinical trials within 28 days before vaccination or plan to participate in other drug clinical trials within 6 months after vaccination; 14. Have an inherited bleeding tendency or abnormal coagulation function (e.g., coagulation factor deficiency, coagulation disorder or thrombocytopenia), or have a history of severe bleeding; 15. Diseases affecting the function of the immune system, such as cancer (other than basal cell carcinoma of the skin), congenital or acquired immune deficiency (e.g., HIV infection), autoimmune diseases, organ transplantation, etc., confirmed by known medical history or diagnosis; 16. Previous history of splenectomy or functional absence of spleen; 17. Long-term use of immunosuppressants, nasal sprays, inhalants or other immunomodulatory drugs (>=14 days of continuous use) within 6 months prior to the trial vaccine (e.g., cortisol hormones: prednisone or similar drugs; interferon, etc.), but allow local use (such as ointment, eye drops), the local use should not exceed the recommended dose in the instructions; 18. Received immunoglobulin and/or blood products in the three months prior to the trial vaccine administration; 19. Suspected or known alcohol dependence or substance abuse that may affect the safety evaluation or affect subject compliance; 20. Plan to relocate permanently from the region before the end of the study or leave the region for an extended period during the study visit; 21. Other factors considered inappropriate by the researchers for inclusion in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 neutralizing antibody titer;adverse event; | — |
Secondary
| Measure | Time frame |
|---|---|
| SARS-CoV-2 neutralizing antibody titer in saliva;SARS-CoV-2 neutralizing antibody titer in plasma;nasopharyngeal mucosal humoral immunity and cellular immunity; | — |
Countries
China
Contacts
Public ContactZhang Zheng
The Third People's Hospital of Shenzhen
Outcome results
None listed