Novel Coronavirus Pneumonia (COVID-19)
Conditions
Sponsors
Yunnan Provincial Center for Disease Control and Prevention
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Adults aged 18 and above who are able to provide legal identity certificate. No gender limit. (2) Healthy subjects or those with underlying disease(such as coronary heart disease, hypertension, diabetes, obesity, etc.) but in stable control; (3) The subjects shall fully understand the content of the informed consent form and the vaccines to be administered in this vaccination, voluntarily sign the informed consent form, and the subjects themselves or their authorized persons* have the ability to use the thermometer, scale and fill in the diary card and contact card as required; Note: Authorized person* refers to the person who assists the volunteer in using the thermometer and scale and filling in diary card/contact card. (4) The subjects shall be able to communicate well with the investigators, as well as understand and comply with the requirements of this study; (5) Have received primary immunization with COVID-19 vaccines without containing antigenic components of the XBB variant at least 3 to 6 months ago of the most recent dose*; *primary immunization:received 2 doses of inactivated COVID-19 vaccines, or 3 doses of Zhifei Recombinant Novel Coronavirus Vaccine(CHO Cell), or 1 dose of Ad5-nCoV(Cancino Biologics). Vaccination interval:for those who have completed primary immunization only, at least 3 months ago of the most recent dose, and for those who have received 1 dose of booster immunization, at least 6 months ago of the most recent vaccination. (6) For female subjects: having used effective methods of contraception after their last menstrual period prior to vaccination of this study ,or having no childbearing potential. (7) No history of COVID-19 infection in the last 3 months; (8) Negative SARS-CoV-2 antigen test result within 24 hours before enrollment.
Exclusion criteria
Exclusion criteria: (1) Positive result for SARS-CoV-2 IgM antibody test on the day of vaccination; (2) Fever within the last 72 hours or axillary temperature was=37.3?on the day of the vaccination; (3) Antipyretic analgesic and anti allergic drugs used in the last 72 hours; (4) Female volunteer who is known to be pregnant, breastfeeding, or was positive in urine pregnancy test on the day of vaccination, or plans to discontinue effective contraception (e.g., intrauterine or implantable contraceptive devices, oral contraceptives, injectable or buried contraceptives, extended-release localized contraceptives, intrauterine devices, condoms (for males), diaphragms, cervical caps, etc.) for 12 months after vaccination; (5) Prior history of allergic reaction or anaphylaxis to any vaccine or drug, e.g., urticaria, serious eczema, difficulty breathing, laryngeal edema, and angioedema etc.; or allergy to essential disinfectant substances used in the study (e.g., 75% alcohol); (6) Receipt of any vaccine within 14 days prior to the vaccination; (7) Have participated in or planned to participate in clinical trials of other drugs within 12 months after vaccination; (8) Hereditary hemorrhagic tendency or coagulation dysfunction (e.g., cytokine defects, coagulation disorders or platelet disorder), or a history of significant bleeding; (9) Asplenia or functional asplenia; (10) Have a serious illness that is not well controlled, such as a malignant tumor, cardiac arrest within the previous 30 days, or other major uncontrolled illness that the investigator believes may pose risks; (11) Long-term use (continuous used=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 vaccines 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. (12) Having received immunoglobulins and/or blood products within 3 months prior to the vaccination in this study; (13) Suspected or known alcohol dependency or drug abuse, which may affect safety evaluation or subject compliance; (14) Planning to permanently move away from the study area before study completion or leave the local area for a long time during the period of study visits; (15) Any other situation that is not suitable for the volunteers to participate in the study at the discretion of the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Live virus neutralizing antibody against current major SARS-CoV-2 VOC;incidence rate of adverse reaction/event; | — |
Secondary
| Measure | Time frame |
|---|---|
| Incidence of adverse reaction/event related to blood biochemistry, blood routine, coagulation routine, and urine routine indicators; | — |
Countries
China
Contacts
Public ContactXiaoqiang Liu
Yunnan Provincial Center for Disease Control and Prevention
Outcome results
None listed