Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:SARS-CoV-2 variants mRNA vaccine (chimera S protein vaccine)
Control group:Recombinant new coronavirus vaccine (CHO cells)
Sponsors
The First Affiliated Hospital of Guangzhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Healthy adults aged >=18 years, who are able to provide legal identity certificate. No gender limit. 2. The subjects shall fully understand the content of the informed consent form and the characteristics of the investigational vaccine, voluntarily sign the informed consent form, as well as have the ability to use thermometer, scale and fill in diary card and contact card as required. 3. The subjects shall be able to communicate well with the investigators, as well as understand and comply with the requirements of this study. 4. The subjects axillary temperature on the day of administration should be less than 37.3?. 5. Subjects had been vaccinated with 3 doses of inactivated COVID-19 vaccine at least 6 months ago (the dosing interval for the Dose 1 and Dose 2 was 28 to 56 days as well as for Dose 1 and Dose 2 was >= 6 months) (only for dosing regimen: three-dose primary series + one dose booster). 6. Subjects had been vaccinated with 2 doses of inactivated COVID-19 vaccine at least 6 months ago (the dosing interval for the Dose 1 and Dose 2 was 28 to 56 days (only for dosing regimen: two-dose primary series + one dose booster).
Exclusion criteria
Exclusion criteria: 1. Clinically significant abnormal results of vital sign during screening period at the discretion of investigators (individuals aged 18-59 years during consciousness: pulse 100/minutes, systolic blood pressure >=140 mmHg or diastolic blood pressure >=90 mmHg; individuals aged 60 years and above during consciousness: pulse 100/minutes, systolic blood pressure >=150 mmHg or diastolic blood pressure >=90 mmHg). 2. Medical history of COVID-19 or prior use of any medications other than 3 doses of inactivated vaccines to prevent COVID-19 (e.g., History of vaccination with any other non-inactivated vaccines that has or has not been marketed or more than 3 doses of inactivated vaccine) (only for four-dose dosing regimen: three-dose primary series + one dose booster). 3. Medical history of COVID-19 or prior use of any medications other than 2 doses of inactivated vaccines to prevent COVID-19 (e.g., History of vaccination with any other non-inactivated vaccines that has or has not been marketed or more than 2 doses of inactivated vaccine) (only for three-dose dosing regimen: 2-dose primary series + one dose booster). 4. Positive SARS-CoV-2 pathogenicity test by RT-PCR (24-hour nucleic acid test results is acceptable). 5. Prior medical history of severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) and other human coronavirus infections or diseases. 6. Fever (axillary temperature >= 37.3?) within recent 72 hours; Use of antipyretics and anti-allergy medications within 72 hours prior to vaccination. 7. Pregnant (e.g., positive pregnancy test) or breastfeeding patients. 8. Individuals who do not use effective contraception within 2 weeks prior to the vaccination; Plan of pregnancy or interruption of effective contraceptive methods within 6 months after the vaccination in this study. 9. Personnel of the study institution or sponsor. 10. Prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., urticaria, serious eczema, difficulty breathing, laryngeal edema, and angioedema etc. 11. Have received any vaccines within 28 days prior to the vaccination of vaccines in this study. 12. Have participated in or planned to participate in clinical studies of other drugs from 28 days prior to vaccination to 12 months after vaccination in this study. 13. Hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or a history of significant bleeding. 14. Known medical history or diagnosis confirming that subjects have diseases affecting immune system function, including cancer (except skin basal cell carcinoma), congenital or acquired immunodeficiency (e.g., infection with human immunodeficiency virus (HIV)), and uncontrolled autoimmune disease. 14.Asplenia or functional asplenia. 15. Asplenia or functional asplenia. 16. Long-term use (continuous use >=14 days) of immunosuppressants or other immunomodulators (e.g., glucocorticoids: prednisone or similar drugs; interferons etc.) within 6 months prior to the vaccination of the investigational products in this study, except for topical medications (e.g., ointments, eye drops, inhalants or nasal sprays). However, the topical medications should not exceed the dose as recommended in the package insert. 17. Having received immunoglobulins and/or blood products within 3 months prior to the vaccination in this study. 18. Suspected or known alcohol dependency or
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 wild type and Beta variant;S protein specific IgG antibody titer;T cell immunity;B cell antibody spectrum;Live virus neutralizing antibody titers against wild type or other variant of SARS-CoV-2; | — |
Countries
China
Contacts
Public ContactZheng Jingping
The First Affiliated Hospital of Guangzhou Medical University
Outcome results
None listed