COVID-19Phase 3NCT06175494
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)
A Phase 3 study testing Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) and Recombinant COVID-19 Variant Vaccine (Sf9 Cell) in people with COVID-19, run by WestVac Biopharma Co., Ltd. at 1 site in China.
Trial summary
The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVac Biopharma Co., Ltd. is a monovalent modified vaccine designed against Omicron XBB.1.5. This is a multi-center, randomized, double-blind, placebo-controlled phase 3 clinical study with two cohorts, i.e. 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 (XBB) Trimer Protein Vaccine (Sf9 Cell) and Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 4,800 participants
- Where
- 1 siteChina
- Study dates
- 19 Dec 2023to 31 Jan 2025
- Phase
- Phase 3
- 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 or immunocompromised.
- Basic or booster vaccination with COVID-19 vaccine ≥3 months.
- No history of SARS-CoV-2 infection history within 3 months, or never infected.
- 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.
Who cannot join
- Axillary temperature ≥37.3℃.
- SARS-CoV-2 antigen or nucleic acid screening positive during the screening period.
- Anti-SARS-CoV-2 IgM antibody screening 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.
- 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.
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- 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.
- Have been diagnosed with congenital or acquired immunodeficiency, HIV infection (including anti-HIV antibody positive during the screening period).
- 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.
- Congenital or acquired angioedema/neuropathic edema.
- 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 vaccination.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Jiangsu Provincial Center for Disease Control and Prevention
Nanjing, Jiangsu, 210009
Fengcai Zhu, Medical
About this study
Official title: A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study 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.
The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVac Biopharma Co., Ltd. is a monovalent modified vaccine designed against Omicron XBB.1.5.
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.
- Conditions
- COVID-19
- Being tested
- Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell), Recombinant COVID-19 Variant Vaccine (Sf9 Cell), Placebo
- 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 (XBB) Trimer Protein Vaccine (Sf9 Cell)Biological
boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)
Recombinant COVID-19 Variant Vaccine (Sf9 Cell)Biological
boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell)
PlaceboBiological
boost with saline
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) Receives: Biological: Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) |
| Control group | Active comparator | Recombinant COVID-19 Variant Vaccine（ Sf9 Cell） Receives: Biological: Recombinant COVID-19 Variant Vaccine (Sf9 Cell) |
| Placebo control group | Placebo comparator | Placebo control Receives: Biological: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy against COVID-19
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of symptomatic COVID-19, regardless of severity, 14 days to 6 months after booster vaccination.
Measured: 14 days to 6 months after vaccination
AEs and ARs
Incidence of adverse events (AEs) and adverse reactions (ARs) 0-7 days after booster vaccination.
Measured: 0-7 days after vaccination
Secondary outcomes (8)
Efficacy against COVID-19
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of moderate/severe COVID-19 caused by SARS-CoV-2 infection, cases of hospitalization due to COVID-19, and cases of death due to COVID-19, > 14 days to 6 months after booster vaccination.
Measured: 14 days to 6 months after booster vaccination
Efficacy against COVID-19
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of symptomatic COVID-19, regardless of severity, 7 days to 6 months after booster vaccination.
Measured: 7 days to 6 months after booster vaccination
Efficacy against COVID-19
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of moderate/severe COVID-19 caused by SARS-CoV-2 infection, cases of hospitalization due to COVID-19, and cases of death due to COVID-19, > 7 days to 6 months after booster vaccination.
Measured: 7 days to 6 months after booster vaccination
AEs and ARs
Incidence of adverse events (AEs) and adverse reactions (ARs) 0-30 days after booster vaccination.
Measured: 0-30 days after booster vaccination
SAEs and AESIs
Incidence of serious adverse events (SAE) and adverse events of special interest (AESI) within 12 months after booster vaccination.
Measured: within 12 months after booster vaccination
Immunogenicity
The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies (true virus and pseudo-virus assay) against SARS-CoV-2 Omicron XBB.1.5 variant and the main circulating strain at that time on day 14 after booster vaccination.
Measured: day 14 after booster vaccination
Immunogenicity
The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of neutralizing antibodies (pseudo-virus assay) against SARS-CoV-2 Omicron XBB.1.5 variant and the main circulating strain at that time on day 14, day 30, 3 months and 6 months after booster vaccination.
Measured: day 14, day 30, 3 months and 6 months after booster vaccination
Immunogenicity
The geometric mean titer (GMT), seroconversion rate and geometric mean fold increase (GMI) of IgG antibodies against SARS-CoV-2 S-RBD protein on day 14, day 30, 3 months and 6 months after booster vaccination.
Measured: day 14, day 30, 3 months and 6 months after booster vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2023
- Study start19 Dec 2023
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jan 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 4,800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- WestVac Biopharma Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- WestVac Biopharma (Guangzhou) Co., Ltd.
- Responsible party
- Sponsor
- Investigators
- Fengcai Zhu, Medical, Principal investigator, Jiangsu Province Centers for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06175494
- Sponsor's protocol ID
- WSKCT018
- Status last verified
- Dec 2023
- First submitted
- 18 Dec 2023
- Last updated
- 23 Apr 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 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Clinical Study 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.
- ClinicalTrials.gov ID
- NCT06175494
- Acronym / sponsor ID
- WSKCT018
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 4,800 participants (estimated)
- Lead sponsor
- WestVac Biopharma Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- WestVac Biopharma (Guangzhou) Co., Ltd.
- Study start
- 19 Dec 2023 (actual)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jan 2025 (estimated)
- First posted
- 19 Dec 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.
The Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) developed by WestVac Biopharma Co., Ltd. is a monovalent modified vaccine designed against Omicron XBB.1.5.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Biological: Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell)Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) |
| Control group | Active comparator | Biological: Recombinant COVID-19 Variant Vaccine (Sf9 Cell)Recombinant COVID-19 Variant Vaccine（ Sf9 Cell） |
| Placebo control group | Placebo comparator | Biological: PlaceboPlacebo control |
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 or immunocompromised.
- Basic or booster vaccination with COVID-19 vaccine ≥3 months.
- No history of SARS-CoV-2 infection history within 3 months, or never infected.
- 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.
Key exclusion criteria (17 listed)
- Axillary temperature ≥37.3℃.
- SARS-CoV-2 antigen or nucleic acid screening positive during the screening period.
- Anti-SARS-CoV-2 IgM antibody screening 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 (XBB) Trimer Protein Vaccine (Sf9 Cell)boost with Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) | Biological | Experimental group |
| Recombinant COVID-19 Variant Vaccine (Sf9 Cell)boost with Recombinant COVID-19 Variant Vaccine (Sf9 Cell) | Biological | Control group |
| Placeboboost with saline | Biological | Placebo control group |
Primary outcome
Efficacy against COVID-19
Time frame: 14 days to 6 months after vaccination
Efficacy against the first occurrence of etiologically confirmed (antigen or PCR-positive) cases of symptomatic COVID-19, regardless of severity, 14 days to 6 months after booster vaccination.
AEs and ARs
Time frame: 0-7 days after vaccination
Incidence of adverse events (AEs) and adverse reactions (ARs) 0-7 days after booster vaccination.
8 secondary outcomes
Efficacy against COVID-19
Time frame: 14 days to 6 months after booster vaccination
Efficacy against COVID-19
Time frame: 7 days to 6 months after booster vaccination
Efficacy against COVID-19
Time frame: 7 days to 6 months after booster vaccination
AEs and ARs
Time frame: 0-30 days after booster vaccination
SAEs and AESIs
Time frame: within 12 months after booster vaccination
Immunogenicity
Time frame: day 14 after booster vaccination
Immunogenicity
Time frame: day 14, day 30, 3 months and 6 months after booster vaccination
Immunogenicity
Time frame: day 14, day 30, 3 months and 6 months after booster vaccination
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 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.
Fengcai Zhu, Medical principal investigator
Jiangsu Province Centers for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Recombinant COVID-19 (XBB) Trimer Protein Vaccine (Sf9 Cell) and Recombinant COVID-19 Variant Vaccine (Sf9 Cell) in people with COVID-19, run by WestVac Biopharma Co., Ltd. at 1 site in China.
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 17 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 23 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Contact Fengcai Zhu, Medical (+86 139 5199 4867, jszfc@jscdc.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Efficacy against COVID-19 (time frame: 14 days to 6 months 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 23 Apr 2024.