Novel Coronavirus Pneumonia (COVID-19)
Conditions
Sponsors
The First People's Hospital of Anning (The Fourth People's Hospital of Kunming)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Subjects shall meet all of the following inclusion criteria: (1) Healthy adults aged =18 years and are able to provide legal identity certificate. Both male and female can be included. (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) Subjects had been vaccinated with 3 doses of inactivated COVID-19 vaccines at least 6 months ago of the third dose. (5) There is risk of SARS-CoV-2 infection due to regional, occupational, activity, environmental and other factors. (6) Healthy subjects or those with underlying disease but in stable control [in a stable state without exacerbation (no need for hospital admission or no major adjustment in treatment regimen, etc.) for at least 3 months prior to enrollment in this study]. (7) Negative SARS-CoV-2 nucleic acid test results within the last 48 hours. (8) For female subjects: having no childbearing potential (amenorrhea for at least 1 year or medical record documented surgical sterilization.) or confirmed being not pregnant or breastfeeding, and used effective contraception after last menstrual period before enrollment.
Exclusion criteria
Exclusion criteria: Subjects who meet any of the following exclusion criteria will not be enrolled: (1) Patients with abnormal vital signs of clinical significance. (2) History of COVID-19 or use of any COVID-19 vaccine other than 3 doses of COVID-19 inactivated vaccine. (3) Suspected COVID-19 infection within 2 months prior to enrollment. (4) Positive SARS-CoV-2 nucleic acid test result on the day of inoculation. (5) A history of severe acute respiratory syndrome (SARS), Middle East Respiratory Syndrome (MERS) and other human coronavirus infection or disease history. (6) axillary temperature =37.3? on the day of inoculation, or fever within 72 hours (axillary temperature =37.3?/ mouth temperature =37.5?) or antipyretic, analgesic and antiallergic drugs were used. (7) The woman is known to be pregnant or lactating or has a positive urine pregnancy test on the day of vaccination or plans to discontinue effective contraception within 3 months after vaccination. (8) The staff of the research team and the sponsor. (9) A history of severe allergic reactions or allergic reactions to vaccines or drugs. (10) Administer any vaccine within 28 days before the study vaccine is administered. (11) Participating in clinical trials of other drugs prior to vaccination with the experimental vaccine or planning to participate in clinical trials of other drugs within 12 months after vaccination. (12) Hereditary bleeding tendency or abnormal coagulation function, or a history of severe bleeding. (13) Confirmation of diseases affecting immune system function, such as cancer (other than basal cell carcinoma of the skin), congenital or acquired immunodeficiency (e.g., HIV infection), and other autoimmune diseases that cannot be controlled by treatment, based on known medical history or diagnosis. (14) Asplenia or functional asplenia. (15) Long-term use of immunosuppressants or other immunomodulatory drugs (e.g., the hormone cortisol: prednisone or similar drugs) within 6 months prior to vaccination (continuous use =14 days); Interferon, etc.), except for topical use (such as ointment, eye drops, inhalant or nasal spray) and the dosage does not exceed the recommended dosage in the instructions. (16) Received immunoglobulin and/or blood products within 3 months prior to vaccination with the experimental vaccine. (17) Suspected or known alcohol dependence or substance abuse that may affect the safety evaluation or affect subject compliance. (18) Plan to permanently relocate from the area before the end of the study or leave the area for a long period of time during the study visit. (19) Other factors deemed inappropriate by the researchers to participate in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Person-year incidence rate of Symptomatic COVID-19 ; | — |
Secondary
| Measure | Time frame |
|---|---|
| Live virus neutralizing antibody against current major SARS-CoV-2 VOC;S protein specific IgG antibody against SARS-CoV-2 Omicron strain; | — |
Countries
China
Contacts
Public ContactMingxuan Zhao
The First People's Hospital of Anning (The Fourth People's Hospital of Kunming)
Outcome results
None listed