Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group:SARS-CoV-2 mRNA vaccine 15ug/0.5ml
Control group:Novel Coronavirus Inactivated Vaccine (Vero Cells)
Sponsors
Yunnan Walvax Biotechnology Co., Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Individuals aged 18 years and above and are able to provide legal identity certificate. Both male and female should be included; 2. The subjects shall fully understand the content of the informed consent form and the characteristics of the study 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. For female subjects: having used effective methods of contraception within 2 weeks prior to enrollment into this study, having a negative pregnancy test (Pregnancy tests are exempted for amenorrhea for at least 1 year or medical record documented surgical sterilization) Subjects voluntarily agree to continue using effective contraceptive methods until 12 months after the complete series. The effective contraceptive methods include oral contraceptives, injectable or embedded contraception, sustained-release topical contraceptives, hormone patches, intrauterine devices (IUD), sterilization, condoms (male), diaphragm, cervical cap, etc.; 5. Healthy subjects or subjects with mild underlying diseases [in a stable status that the disease does not worsen (requiring no hospitalization for treatment or no major adjustment of treatment regimens) for at least 3 months prior to enrollment into this study].; 6. Subjects had completed the 2-dose series vaccination of Sinovac COVID-19 vaccine at least 5 months (and less than 7 months) with the dosing interval being 3 to 8 weeks.
Exclusion criteria
Exclusion criteria: 1. Medical history of COVID-19 or prior use of any medications other than 2 doses of inactivated vaccines to prevent COVID-19; 2. Abnormal laboratory test values are observed during screening period (exceed the upper or lower limit of the normal reference range by 1.2 times) and are considered clinically significant by the investigator (stage 1 subjects only); abnormal blood pressure and pulse detection results are observed during screening period (for conscious subjects aged 18 to 59 years: pulse 100 times /min, systolic blood pressure >= 140mmHg or diastolic blood pressure >= 90mmHg; for conscious subjects aged 60 years and above: pulse 100 times /min, systolic blood pressure >= 150 mmHg or diastolic blood pressure >= 90mmHg) and are considered clinically significant by investigator; 3. Prior medical history of severe acute respiratory syndrome (SARS), middle east respiratory syndrome (MERS) and other human coronavirus infections or diseases; 4. Fever (oral temperature >= 37.5 degree C/ axillary temperature >= 37.3 degree C) on the day of the vaccination or within recent 72 hours or use of over-the-counter drugs such as antipyretic analgesics (e.g., acetaminophen, ibuprofen, naproxen, etc.) within 12 hours before vaccination; 5. Pregnant (e.g., positive pregnancy test) or breastfeeding women; 6. Plan of pregnancy or interruption of effective contraceptive methods within 6 months after the vaccination in this study; 7. Personnel of the study institution or sponsor; 8. Prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., urticaria, serious eczema, difficulty breathing, laryngeal edema, and angioedema etc.; 9. Have inoculated with any vaccines from 28 days prior to the vaccination; 10. Planned to participate in clinical studies of other drugs from 28 days prior to vaccination to 12 months after vaccination in this study; 11. Hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or a history of significant bleeding; 12. 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)), uncontrolled autoimmune disease; 13. Asplenia or functional asplenia; 14. Long-term use (continuous use >= 14 days) of immunosuppressants or other immunomodulators (e.g., glucocorticoids: prednisone or similar drugs) within 6 months prior to the first vaccination 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 prescribing information or be administered to those with any signs of systemic exposure. 15. Having received immunoglobulins and/or blood products within 3 months prior to the vaccination in this study; 16. Suspected or known alcohol dependency or drug abuse, which may affect safety evaluation or subjects compliance; 17. Planning to permanently move away from the study area before study completion or leav
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibody as measured by wild-type virus neutralization assay;Neutralizing antibody as measured by pseudovirus neutralization assay;IgG antibody; | — |
Countries
China
Contacts
Public ContactYuan Lin
Yunnan Walvax Biotechnology Co., Ltd.
Outcome results
None listed