Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Experimental group :WSK-V102 C
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 in the year prior to receiving the trial vaccine; 9. Absence of spleen or functional absence of spleen; 10. The patient is pregnant or lactating, or plans to become pregnant or an egg donor during the trial; 11. Medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the patient's signing of informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse reaction after vaccination;Enhanced protective efficacy of COVID-19 from SARS-CoV-2 infection occurring 14 days after immunization; | — |
Secondary
| Measure | Time frame |
|---|---|
| The incidence of adverse events after vaccination;Geometric mean titer (GMT), geometric mean growth ratio (GMI) and positive turn rate of specific neutralizing antibody against SARS-CoV-2 prototype strain (true virus or false virus neutralization test) at 14 days and 3 months after immunization enhancement;Geometric mean titer (GMT), geometric mean growth multiple (GMI) and positive turn rate of S-RBD protein specific antibody (ELISA) against SARS-CoV-2 at day 14 and 3 months after immunization enhancement; | — |
Countries
China
Contacts
Public ContactLi Weimin
West China Hospital of Sichuan University
Outcome results
None listed