Not yet recruitingNCT05911048Updated Jul 25, 2024

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

A Phase 2 interventional study of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101) in COVID-19, sponsored by WestVac Biopharma Co., Ltd.. Not yet recruiting. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-07-25.

Sponsored by WestVac Biopharma Co., Ltd. · Phase 2, Interventional, and Prevention

From the registry’s dates

Primary completion was expected by Jun 2025, 1 year 3 months ago, but the record still lists the study as not yet recruiting.

Phase: Phase 2
Study type: Interventional
Enrollment: 3,100
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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.

Conditions studied

COVID-19

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COVID-19 7,640

In context

COVID-19

7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.

This study's planned enrollment of 3,100 is above the median of 100 across 4,099 interventional studies indexed under COVID-19.

Browse COVID-19 studies →

Lead sponsor

WestVac Biopharma Co., Ltd. is the lead sponsor of 13 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

Subjects aged 18 years and above, including those with underlying diseases and immunocompromised subjects.
Basic or booster immunization with COVID-19 vaccine ≥6 months.
≥3 months of SARS-CoV-2 infection history, or never infected.
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

Exclusion Criteria:

Axillary temperature ≥37.3℃.
SARS-CoV-2 antigen or nucleic acid screening positive within the last 48 hours.
Anti-SARS-CoV-2 IgM antibody was positive during the screening period.
It is in the advanced stage of malignant tumor and the disease control is unstable.
Female pregnancy (pregnancy test results are positive), lactation period.
Have serious cardiovascular diseases, such as arrhythmia, conduction block, myocardial infarction, heart failure, severe hypertension, and can not be controlled by drugs.
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.
Have been diagnosed with congenital or acquired immunodeficiency, HIV infection.
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.
Congenital or acquired angioedema/neuroedema.
Asplenia or functional asplenia.
Thrombocytopenia or other clotting disorders (which may cause intramuscular injection contraindications).
Received another investigational drug within 1 month prior to receiving the investigational vaccine.
Received subunit or inactivated vaccine within 14 days prior to receiving the investigational vaccine, or received live attenuated vaccine within 1 month.
Fertile female subjects did not use effective contraception within 1 month prior to enrollment.
Fertile female and male subjects have pregnancy plans and sperm/egg donation plans from the screening period to 3 months after immunization.
Abnormal laboratory test results during the screening period, which were judged by the researcher to be unsuitable for the study vaccine.
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

Phase: Phase 2
Primary purpose: Prevention
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 3,100 participants (estimated)

Study arms

Experimental
Experimental group
Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
Biological: Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
Active comparator
Control group
Recombinant COVID-19 Vaccine (Sf9 Cell)(WSK-V101)
Biological: Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)

Interventions

BiologicalRecombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
boost with Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
BiologicalRecombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)
boost with Recombinant COVID-19 vaccine (Sf9 Cell) (WSK-V101)

What researchers measure

Primary outcomes

AE and AR
Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination.
Time frame: 0-7 days after vaccination
Primary Immunogenicity indicator
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.
Time frame: day 14 post-vaccination

Secondary outcomes

AE and AR
Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days post-vaccination.
Time frame: 0-30 days post-vaccination.
SAE and AE
Incidence of serious adverse events (SAE) and adverse events of specific interest (AESI) within 12 months post-vaccination.
Time frame: within12 months post-vaccination.
Secondary Immunogenicity indicator 1
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.
Time frame: day 14 post-vaccination.
Secondary Immunogenicity indicator 2
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.
Time frame: day 14 post-vaccination
Secondary Immunogenicity indicator 3
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.
Time frame: day 30 post-vaccination.
Secondary Immunogenicity indicator 4
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.
Time frame: 14 and 30 days post-vaccination.

Study locations

No study locations are listed for this record.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Jul 25, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05911048
Lead sponsor: WestVac Biopharma Co., Ltd.
Responsible party: Sponsor
First posted: Jun 20, 2023
Start date: Dec 30, 2024 (estimated)
Primary completion: Jun 30, 2025 (estimated)
Completion: Dec 30, 2025 (estimated)
Last update: Jul 25, 2024

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2024. You cannot join it, but the record below documents what was studied.

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Discussion

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