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

Phase 2

Not yet recruiting

• Conditions: COVID-19
• Interventions: Biological: Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C); Biological: Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)

• Registration Number: NCT05911048
• Lead 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.

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 Timeline

• Study First Submitted: 2023-06-16
• Study First Submitted QC: 2023-06-19
• Study First Posted: 2023-06-20
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25
• Study Start: 2024-12-30
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 3100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental group	Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)	Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
Control group	Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)	Recombinant COVID-19 Vaccine (Sf9 Cell)(WSK-V101)

Primary Outcome Measures

Name	Time	Method
AE and AR	0-7 days after vaccination	Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination.
Primary Immunogenicity indicator	day 14 post-vaccination	The geometric mean titer (GMT) and seroconversion of neutralizing antibodies (true virus or pseudovirus method) against the current variants of SARS-CoV-2 (such as XBB and its subtypes) at day 14 post-vaccination.

Secondary Outcome Measures

Name	Time	Method
SAE and AE	within12 months post-vaccination.	Incidence of serious adverse events (SAE) and adverse events of specific interest (AESI) within 12 months post-vaccination.
Secondary Immunogenicity indicator 3	day 30 post-vaccination.	Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) against SARS-CoV-2 prototype strains, current variants (such as XBB and its subtypes) and Omicron BA.2 variants neutralizing antibodies (true virus or pseudovirus method) at day 30 post-vaccination.
Secondary Immunogenicity indicator 1	day 14 post-vaccination.	Geometric mean titer (GMT) and seroconversion rate of neutralizing antibody (true virus or pseudovirus method) against SARS-CoV-2 prototype strain and Omicron BA.2 variant strain on day 14 post-vaccination.
AE and AR	0-30 days post-vaccination.	Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days post-vaccination.
Secondary Immunogenicity indicator 2	day 14 post-vaccination	Geometric mean fold increase (GMI) of neutralizing antibodies against SARS-CoV-2 prototype strains, current variants (such as XBB and its subtypes), and Omicron BA.2 variants (true virus or pseudovirus method) on day 14 post-vaccination.
Secondary Immunogenicity indicator 4	14 and 30 days post-vaccination.	Geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of anti-SARS-CoV-2 specific binding antibodies at 14 and 30 days after vaccination.