Novel coronavirus pneumonia(COVID-19)
Conditions
Interventions
Investigational Group 1:BIBP-Inactivated COVID-19 vaccine (Omicron)
Investigational Group 2:WIBP-Inactivated COVID-19 vaccine (Omicron)
Investigational Group 3:BIBP-Inactivated COVID-19 vaccine (Omicron)
Investigational Group 4:WIBP-Inactivated COVID-19 vaccine (Omicron)
Control Group 1:Inactivated vaccine (prototype)
Control Group 2:Inactivated vaccine (prototype)
Sponsors
University of Hong Kong
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Age range: populations aged 18 years and above. 2. Judged by the investigator that the health condition is well after inquiry and physical examination. 3. Vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine or mRNA COVID-19 vaccine for >= 3 months. 4. Female participants who are not nursing or pregnant at the time of enrolment (negative urine pregnancy test) and have no family planning within the first 6 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before inclusion. 5. During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan. 6. With the self ability to understand the study procedures, the informed consent & voluntarily sign an informed consent form and is able to comply with the requirements of the clinical study protocol.
Exclusion criteria
Exclusion criteria: 1. Confirmed cases, suspected cases or asymptomatic cases of COVID-19; 2. With a history of SARS and MERS infection (self-report, on-site inquiry); 3. Has vaccinated with one or four doses and above COVID-19 vaccine; 4. Axillary Temperature >= 37.3 degree (Tympanic temperature >= 37.6 degree); 5. Previous allergic reactions to drug or vaccination (such as acute allergic reactions, urticaria, eczema, dyspnea, angioneurotic edema, or abdominal pain) or allergy to known components of COVID-19 vaccine (self-report, onsite inquiry); 6. Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders(self-report, onsite enquiry); 7. With known immunological impairment or immunocompromised diagnosed by the hospital(self-report, onsite enquiry); 8. Have an uncontrolled epilepsy and other progressive neurological diseases or a history of Guillain-Barre syndrome (self-report, onsite enquiry); 9. Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry); 10. Known or suspected severe illness includes: respiratory illness, acute infection or active attacks of chronic illness, liver and kidney disease, severe diabetes mellitus, malignant tumor, infectious or allergic skin disease, HIV infection (self-report, onsite enquiry, provide test report if available); 11. With hospital-diagnosed serious cardiovascular diseases [cardiopulmonary failure, drug-uncontrolled hypertension (physical examination of systolic blood pressure >= 140 mmHg and/or diastolic blood pressure >= 90 mmHg)), acute attacks of chronic respiratory illness (self-report, onsite enquiry); 12. Received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry); 13. Received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry); 14. Participating or planning to participate in other interventional vaccine clinical trials during this study; 15. Other vaccination-related contraindications considered by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GMT and 4-fold rise rate of anti-omicron neutralizing antibody;Incidence of adverse reactions/events;Incidence of adverse reactions/events;Incidence of SAE/AESI; | — |
Secondary
| Measure | Time frame |
|---|---|
| GMT and 4-fold rise rate of anti-omicron neutralizing antibody;GMT of anti-omicron IgG antibody, 4-fold rise rate, GMI, and proportions of neutralizing antibody titered >= 1: 16, >= 1: 32 and >= 1: 64;GMTs of anti-omicron neutralizing antibody and IgG antibody and the proportions of neutralizing antibody titer >= 1: 16, >= 1: 32 and >= 1: 64; | — |
Countries
China
Contacts
Public ContactIvan Hung
University of Hong Kong
Outcome results
None listed