Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Test group:WSK-V102D
Sponsors
West China Hospital of Sichuan University
Eligibility
Sex/Gender
All
Age
18 Years to 120 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years; 2. Obtain the informed consent of volunteers and sign the informed consent; 3. The volunteers were able and willing to comply with the requirements of the clinical trial protocol, and were able to complete the 6-month study follow-up; 4. Two or three doses of COVID-19 vaccine should be given, and the interval between the last dose and the current dose should be >= 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 methods (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 reaction in the past, allergy 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 centigrade; 5. Severe cardiovascular disease, 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 during field measurement); 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 1 year before receiving the experimental vaccine; 9. Absence of spleen or functional absence of spleen; 10. Women who are pregnant or breastfeeding, or who plan to become pregnant or donate eggs during the trial; 11. Medical, psychological, social or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect subjects to sign informed consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse reaction within 7 days after vaccination;The incidence of adverse reaction within 30 days 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 event within 7 days after vaccination;The incidence of adverse event within 30 days after vaccination;The incidence of serious adverse reaction within 6 months after vaccination;Geometric mean titer (GMT), geometric mean increase fold (GMI) and seroconversion of specific neutralizing antibody against SARS-CoV-2 prototype strain (true virus or false virus neutralization test) at 14 days after immunization enhancement;Geometric mean titer (GMT), geometric mean increase fold (GMI) and seroconversion rate of S-RBD protein specific IgG antibody (ELISA) against SARS-CoV-2 at day 14 after immunization enhancement;Eometric mean titer (GMT), geometric mean increase fold (GMI) and seroconversion of specific neutralizing antibody against SARS-CoV-2 Omicron variant (true virus or false virus neutralization test) at day14 after immunization ;Geometric mean titer (GMT), geometric mean increase fold (GMI) and seroconversion rate of specific neutralizing antibody against SARS-CoV-2 (true virus or false virus neutralization test) at 3 months after immunization enhancement;Geometric mean titer (GMT), geometric mean increase fold (GMI) and seroconversion of S-RBD protein specific antibody (ELISA) against SARS-CoV-2 at 3 months after immunization enhancement; | — |
Countries
China
Contacts
Public ContactWeimin Li
West China Hospital of Sichuan University
Outcome results
None listed