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NCT05911048 | NOT YET RECRUITING | COVID-19

A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination
Sponsor:

WestVac Biopharma Co., Ltd.

Brief Summary:

A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination to evaluate safety and immunogenicity in healthy population aged 18 years old and above.

Condition or disease

COVID-19

Intervention/treatment

Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)

Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)

Phase

PHASE2

Detailed Description:

To evaluate safety of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and immunogenicity superiority of WSK-V101C to Recombinant COVID-19 vaccine (WSK-V101) after booster.

Study Type : INTERVENTIONAL
Estimated Enrollment : 3100 participants
Masking : DOUBLE
Primary Purpose : PREVENTION
Official Title : A Clinical Trial to Evaluate the Safety and Immunogenicity of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) in Booster Vaccination in Healthy Population 18 Years Old of Age and Above
Actual Study Start Date : 2024-12-30
Estimated Primary Completion Date : 2025-06-30
Estimated Study Completion Date : 2025-12-30

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: 1
Criteria
Inclusion Criteria
  • 1. Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
  • 2. Basic or booster immunization with COVID-19 vaccine ≥6 months.
  • 3. ≥3 months of SARS-CoV-2 infection history, or never infected.
  • 4. Have the ability to understand research procedures, with informed consent, voluntarily sign informed consent, and be able to comply with the requirements of clinical research protocols.
Exclusion Criteria
  • 1. Axillary temperature ≥37.3℃.
  • 2. SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
  • 3. Anti-SARS-CoV-2 IgM antibody was 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. Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs.
  • 7. Have 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.
  • 9. People who are allergic to any component of the investigational vaccine have a history of more severe allergies or allergic reactions to the vaccine in the past.
  • 10. Congenital or acquired angioedema/neuroedema.
  • 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 immunization.
  • 17. Abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine.
  • 18. 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.
A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination

Location Details

NCT05911048

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