Sequential Immunization of Two Doses of Inactivated COVID-19 Vaccine (Omicron) in Vaccinated Population Aged 18 Years and Above
Phase 3
Active, not recruiting
- Conditions
- COVID-19
- Registration Number
- NCT05382871
- Lead Sponsor
- China National Biotec Group Company Limited
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1804
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method The Geometric Mean Titer （GMT） of anti-omicron neutralizing antibody 28 days after sequential vaccination of 2 doses The 4-fold rise rate of anti-omicron neutralizing antibody 28 days after sequential vaccination of 2 doses
- Secondary Outcome Measures
Name Time Method The 4-fold rise rate 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 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 GMT of anti-omicron neutralizing antibody 14 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 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
Trial Locations
- Locations (1)
Queen Mary Hospital
🇭🇰Hong Kong, Hong Kong
Queen Mary Hospital🇭🇰Hong Kong, Hong Kong