Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
test group:WSK-V106C
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1) =18 years of age; 2) Obtain the informed consent of the volunteer and sign the informed consent; 3) The volunteers were able and willing to comply with the requirements of the clinical trial protocol and complete study follow-up; 4) Complete 2 or 3 doses of novel coronavirus vaccine, and the interval between the last dose and the current dose is not less than 3 months; 5) Fertile men and women of childbearing age voluntarily use effective contraception from signing the informed form until 3 months after completion of vaccination, This includes abstinence or effective birth control (such as intrauterine or implantable devices, oral contraceptives, injected or embedded contraception, slow-release topical contraceptives, intrauterine devices (IUD), condoms (for men), diaphragms, cervical caps, etc.).
Exclusion criteria
Exclusion criteria: 1) People who are allergic to any component of the study vaccine, have a history of severe vaccine allergic reactions in the past, allergies or asthma; 2) History or family history of convulsions, epilepsy, encephalopathy and psychosis; 3) Vaccine-related severe adverse reactions after previous vaccination; 4) Armpit body temperature =37.3?; 5) Severe cardiovascular disease, such as arrhythmia, block, myocardial infarction, severe hypertension that cannot be controlled by medication (systolic blood pressure =180mmHg and/or diastolic blood pressure =110mmHg when measured in the field); 6) Suffering from serious chronic diseases or advanced diseases that cannot be controlled smoothly, such as diabetes, thyroid disease, etc.; 7) Congenital or acquired angioedema/neuroedema; 8) Developed urticaria within 1 year before receiving the experimental vaccine; 9) asplenia or functional asplenia; 10) The woman is pregnant or lactating, or plans to become pregnant or an egg donor during the trial; 11) Subjects who had acute sinusitis, acute rhinitis, or chronic sinusitis, chronic rhinitis with acute symptoms within 3 days prior to vaccination; 12) Nasal granuloma, deviated nasal septum, nasal polyps and other nasal abnormalities that may affect specimen collection or vaccination as determined by clinicians; 13) Received any intranasal medication or nasal surgical treatment within 7 days prior to vaccination; 14) Medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the incidence of adverse reaction within 14 days after each vaccination;Geometric mean titer (GMT), geometric mean growth ratio (GMI) and positive turnover of serum against SARS-CoV-2 Omicron variant (true virus or false virus neutralization test) on day 14 after the second dose of enhanced immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse event within 14 days after each vaccination;Incidence of adverse events (AE) and adverse reactions (AR)30 days after the first dose to the second dose of booster immunization;;Incidence of serious adverse events 6 months after the first dose to the second dose of booster immunization;;Geometric mean titer (GMT), geometric mean growth ratio (GMI) and positive turnover of serum anti-SARS-CoV-2 Omicron variant specific neutralization antibody (true virus or false virus neutralization test) of subjects on the 30th day after the second dose of enhanced immunization;Geometric mean titer (GMT), geometric mean growth ratio (GMI) and positive turnover of serum against SARS-CoV-2 specific IgG antibody (ELISA) at day 14 and day 30 after the second dose of enhanced immunization; | — |
Countries
China
Contacts
Public ContactWeimin Li
West China Hospital of Sichuan University
Outcome results
None listed