A Phase 3 Clinical Study to Evaluate the Efficacy, Safety and Immunogenicity of Booster Vaccination With Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
NCT ID: NCT06175494
Last Updated: 2024-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
4800 participants
INTERVENTIONAL
2023-12-19
2025-01-31
Brief Summary
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This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical study with two cohorts, i.e. the immuno-bridging observational cohort and the efficacy observational cohort, aims to evaluate the efficacy, safety, and immunogenicity of booster vaccination with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) for the prevention of SARS-CoV-2 infection in a population of 18 years of age and older.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
QUADRUPLE
Study Groups
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Experimental group
Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
Control group
Recombinant COVID-19 Variant Vaccine（ Sf9 Cell）
Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
Placebo control group
Placebo control
Placebo
boost with saline
Interventions
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Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
Placebo
boost with saline
Eligibility Criteria
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Inclusion Criteria
2. Basic or booster vaccination with COVID-19 vaccine ≥3 months.
3. No history of SARS-CoV-2 infection history within 3 months, or never infected.
4. Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent form, and be able to comply with the requirements of clinical study protocol.
Exclusion Criteria
2. SARS-CoV-2 antigen or nucleic acid screening positive during the screening period.
3. Anti-SARS-CoV-2 IgM antibody screening positive during the screening period.
4. It is in the advanced stage of malignant tumor and the disease control is unstable.
5. Female pregnancy (pregnancy test results are positive), lactation period.
6. Suffering from serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure etc.; suffering from severe hypertension that can not be controlled by drugs.
7. Suffering from other serious chronic conditions such as uncontrolled asthma, diabetes, chronic obstructive pulmonary disease, pulmonary embolism, chronic kidney disease requiring dialysis, cirrhosis of the liver, convulsions, epilepsy and other neurological/psychiatric conditions.
8. Have been diagnosed with congenital or acquired immunodeficiency, HIV infection (including anti-HIV antibody positive during the screening period).
9. People who are allergic to any component of the investigational vaccine and have a history of severe allergies or vaccine allergic reactions in the past.
10. Congenital or acquired angioedema/neuropathic edema.
11. Asplenia or functional asplenia.
12. Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications).
13. Received another investigational drug within 1 month prior to receiving the investigational vaccine.
14. Received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month.
15. Fertile female subjects did not use effective contraception within 1 month prior to enrollment.
16. Fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after vaccination.
17. Medical, psychological, social, or other conditions that, in the investigator's judgment, are inconsistent with the protocol or affect the subject's signing of informed consent.
18 Years
ALL
Yes
Sponsors
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WestVac Biopharma (Guangzhou) Co., Ltd.
UNKNOWN
WestVac Biopharma Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Fengcai Zhu, Medical
Role: PRINCIPAL_INVESTIGATOR
Jiangsu Provincial Center for Disease Control and Prevention
Locations
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Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, China
Countries
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Central Contacts
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Facility Contacts
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Fengcai Zhu, Medical
Role: primary
Other Identifiers
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WSKCT018
Identifier Type: -
Identifier Source: org_study_id
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