COVID-19Phase 2NCT05911048
A Clinical Trial of Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) in Booster Vaccination
A Phase 2 study testing Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101) in people with COVID-19, run by WestVac Biopharma Co., Ltd..
Trial 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 more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3,100 participants
- Where
- No sites listed yet
- Study dates
- 30 Dec 2024to 30 Dec 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
About this study
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
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
- COVID-19
- Being tested
- Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C), Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)Biological
boost with Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C)
Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)Biological
boost with Recombinant COVID-19 vaccine (Sf9 Cell) (WSK-V101)
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) Receives: Biological: Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) |
| Control group | Active comparator | Recombinant COVID-19 Vaccine (Sf9 Cell)(WSK-V101) Receives: Biological: Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101) |
What is being measured
The primary outcome is the main question the study is designed to answer.
AE and AR
Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination.
Measured: 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.
Measured: day 14 post-vaccination
Secondary outcomes (6)
AE and AR
Incidence of adverse events (AE) and adverse reactions (AR) 0-30 days post-vaccination.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 14 and 30 days post-vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2023
- Study start30 Dec 2024 (estimated)
- Primary completion30 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 3,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05911048
- Sponsor's protocol ID
- WSKCT016
- Status last verified
- Jul 2024
- First submitted
- 16 Jun 2023
- Last updated
- 25 Jul 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05911048
- Acronym / sponsor ID
- WSKCT016
- Conditions
- COVID-19
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 3,100 participants (estimated)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Dec 2024 (estimated)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 20 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: 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 | Active comparator | Biological: Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)Recombinant COVID-19 Vaccine (Sf9 Cell)(WSK-V101) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Recombinant 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) | Biological | Experimental group |
| Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101)boost with Recombinant COVID-19 vaccine (Sf9 Cell) (WSK-V101) | Biological | Control group |
Primary outcome
AE and AR
Time frame: 0-7 days after vaccination
Incidence of adverse events (AE) and adverse reactions (AR) 0-7 days after vaccination.
Primary Immunogenicity indicator
Time frame: 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.
6 secondary outcomes
AE and AR
Time frame: 0-30 days post-vaccination.
SAE and AE
Time frame: within12 months post-vaccination.
Secondary Immunogenicity indicator 1
Time frame: day 14 post-vaccination.
Secondary Immunogenicity indicator 2
Time frame: day 14 post-vaccination
Secondary Immunogenicity indicator 3
Time frame: day 30 post-vaccination.
Secondary Immunogenicity indicator 4
Time frame: 14 and 30 days post-vaccination.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Recombinant COVID-19 Bivalent (XBB+Prototype) Protein Vaccine (Sf9 Cell) (WSK-V101C) and Recombinant COVID-19 vaccine(Sf9 Cell) (WSK-V101) in people with COVID-19, run by WestVac Biopharma Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AE and AR (time frame: 0-7 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jul 2024.