Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
low-level group:WSK-V106
middle-level group:WSK-V106
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years; 2. Obtain the informed consent of volunteers and sign the informed consent; 3. The subject is able and willing to comply with the requirements of the clinical trial protocol and complete the 6-month study follow-up; 4. Complete two or three doses of COVID-19 vaccine, with the interval between the last dose and the current vaccination >=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. Patients 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 convulsion, epilepsy, encephalopathy and psychosis; 3. Severe vaccination-related adverse reactions after previous vaccination; 4. Armpit body temperature >=37.3?; 5. Patients with more serious cardiovascular diseases, such as arrhythmia, block, myocardial infarction, and 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 and thyroid diseases; 7. Congenital or acquired angioedema/neuroedema; 8. Developed urticaria within 1 year before receiving the experimental vaccine; 9. Absence of spleen or functional absence of spleen; 10. The patients is pregnant or lactating, or plans to become pregnant or an egg donor during the trial; 11. Patients 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 patients 's signing of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse reaction within 14 days after each vaccination;The incidence of adverse reactions (AR) 30 days after the first dose to the second dose of booster immunization;Enhanced protective efficacy of COVID-19 from SARS-CoV-2 infection occurring 14 days after last vaccination; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse event within 14 days after each vaccination;Incidence of adverse events (AE) 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;The geometric mean titer (GMT), geometric mean growth factor (GMI) and seroconversion rate of the subject's serum anti-SARS-CoV-2 prototype strain-specific neutralizing antibody (true virus or pseudovirus neutralization test method) on the 14th day after the second dose of booster immunization ;Geometric mean titer (GMT), geometric mean growth multiple (GMI) and seroconversion rate of specific antibody (ELISA) against SARS-CoV-2 at day 14 and 3 months after the second dose of booster immunization; | — |
Countries
China
Contacts
Public ContactLi Weimin
West China Hospital of Sichuan University
Outcome results
None listed