COVID-19
Conditions
Brief summary
This trial adopts a randomized, double-blind and positive control design, it is planned to recruit 1800 healthy participants who have been vaccinated with 2/3 doses of COVID-19 inactivated vaccine or mRNA vaccine for 3 months. The participants will be divided into two strata according to the types of vaccines administered, including 900 participants of COVID-19 inactivated vaccine and 900 participants of mRNA vaccine. According to the ratio of 1:1:1, each stratum was randomly assigned to three groups: sequential BIBP- COVID-19 inactivated vaccine (Omicron), WIBP-COVID-19 inactivated vaccine (Omicron) or COVID-19 inactivated vaccine (prototype strain). And according to D0, D28 immunization schedule, two doses of corresponding group vaccines are sequentially administered.
Interventions
BIOLOGICALBIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
intramuscular injection in the deltoid muscle
BIOLOGICALWIBP Omicron Inactivated COVID-19 vaccine (Vero Cell)
intramuscular injection in the deltoid muscle
intramuscular injection in the deltoid muscle
Sponsors
Beijing Institute of Biological Products Co Ltd.
Wuhan Institute of Biological Products Co., Ltd
The University of Hong Kong
China National Biotec Group Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* Age range: populations aged 18 years and above. * Judged by the investigator that the health condition is well after inquiry and physical examination. * Vaccinated with 2 doses/3 doses of inactivated COVID-19 vaccine or mRNA vaccine for ≥ 3 months. * 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 7 months after enrollment. Effective contraceptive measures have been taken within 2 weeks before inclusion. * During the whole follow-up period of the study, be able and willing to complete the whole prescribed study plan. * With 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
* Confirmed cases, suspected cases or asymptomatic cases of COVID-19; * With a history of Severe Acute Respiratory Syndrome (SARS) and Middle East Respiratory Syndrome (MERS) (self-report, on-site inquiry); * Has vaccinated with one or four doses and above COVID-19 vaccine; * Axillary temperature ≥37.3℃ (Tympanic temperature ≥ 37.6 ℃); * 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 enquiry); * Have a history of hospital-diagnosed thrombocytopenia or other coagulation disorders (self-report, onsite enquiry); * With known immunological impairment or immunocompromised diagnosed by the hospital (self-report, onsite enquiry); * Have an uncontrolled epilepsy and other progressive neurological diseases or a history of Guillain-Barre syndrome (self-report, onsite enquiry); * Received whole blood, plasma and immunoglobulin therapy within 1 month (self-report, onsite enquiry); * 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, Human Immunodeficiency Virus (HIV) infection (self-report, onsite enquiry, provide test report if available); * 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); * Received live attenuated vaccines within 1 month before vaccination (self-report, onsite enquiry); * Received inactivated vaccines within 14 days before vaccination (self-report, onsite enquiry); * Participating or planning to participate in other interventional vaccine clinical trials during this study * Other vaccination-related contraindications considered by investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The 4-fold rise rate of anti-omicron neutralizing antibody | 28 days after sequential vaccination of 2 doses |
| The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody | 28 days after sequential vaccination of 2 doses |
Secondary
| Measure | Time frame |
|---|---|
| Specific cellular immune response | within 28 days after vaccination |
| The GMT of anti-omicron Immunoglobulin G (IgG) antibody | 28 days after sequential vaccination of 2 doses |
| The proportions of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64 | 28 days after sequential vaccination of 2 doses |
| The GMT of anti-omicron neutralizing antibody | 14 days after sequential vaccination of 2 doses |
| The incidence of any adverse reactions/events | 28 days after each immunization |
| The incidence of serious adverse events (SAE) and adverse events special interest (AESI) | from 1st booster dose and up to 6 months following 2nd booster dose |
| The proportion of subjects with neutralizing antibody GMT ≥1:16，≥1:32 and ≥1:64 | on 3rd month, 6th month, 9th month, and 12th month after vaccination |
| The 4-fold rise rate of anti-omicron neutralizing antibody | 14 days after sequential vaccination of 2 doses |
Other
| Measure | Time frame |
|---|---|
| The incidence of COVID-19 cases , including severe cases and deaths accompanied by COVID-19 | From 14 day after vaccination |
Countries
Hong Kong
Outcome results
None listed