COVID-19Phase 3NCT06567457
Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
A Phase 3 study testing SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 and SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty.
Trial summary
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment. 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?
- SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 and SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Oct 2023to Oct 2024
- 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
- Male or female ≥18 years of age.
- Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
- Individuals willing and able to give an informed consent, prior to screening.
- Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
- Individuals who received three doses of inactivated COVID-19 vaccine
Who cannot join
- Body temperature >37.8°C (axillary), or any acute illness at baseline.
- Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
- Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- Any progressive unstable or uncontrolled clinical conditions.
- Individuals who are pregnant, or breastfeeding, or planning to become pregnant while enrolled in this study or during the study period.
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- History of severe adverse reaction associated with a vaccine or severe allergic reaction.
- History of malignancy within 1 year before screening.
- Individuals who have received any other investigational product.
- Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
- Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
- Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
- Administration of intravenous immunoglobulins and/or any blood products.
- Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
About this study
Official title: Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Monovalent Omicron XBB.1.5 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
Read the detailed description
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
- Conditions
- COVID-19
- Being tested
- SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19, SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19Biological
intramuscular injection
SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19Biological
intramuscular injection
| Study group | Role | What they receive |
|---|---|---|
| SCB-2023B | Experimental | Participants will receive one booster dose with SCB-2023B vaccine on Day 1 Receives: Biological: SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 |
| SCB-2019 | Active comparator | Participants will receive one booster dose with SCB-2019 vaccine on Day 1 Receives: Biological: SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 |
What is being measured
The primary outcome is the main question the study is designed to answer.
GMT ratio
Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
Measured: Day 15
Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine
Proportion of participants with local and systemic AEs
Measured: Day 7
Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
Proportion of participants with unsolicited AEs
Measured: Day 29
Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
Measured: Up to 1 year post-vaccination
Secondary outcomes (9)
Non-inferiority of the Omicron XBB.1.5 immune response elicited by SCB-2023B vaccine versus SARS-CoV-2 Delta titers in a subset of naïve participants of the CLO-SCB-2019-003 clinical study (virus neutralization assay)
GMT ratio
Measured: Day 15
GMTs
Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5
Measured: Day 1, 15, 180
GMFRs
Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5
Measured: Day 1, 15, 180
SCRs
Proportion of subjects with seroconversion by virus neutralization assay against Omicron XBB1.5
Measured: Day 1, 15, 180
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5
Proportion of participants with antibody titer ≥ LLoQ
Measured: Day 1, 15, 180
GMTs
Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains
Measured: Day 1, 15
GMFRs
Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains
Measured: Day 1, 15
SCRs
Proportion of subjects with seroconversion by virus neutralization assay against new emergent SARS-CoV-2 strains
Measured: Day 1, 15
Proportion of subjects with antibody titer >=LLOQ
Proportion of participants with antibody titer ≥ LLoQ by virus neutralization assay against new emergent SARS-CoV-2 strains
Measured: Day 1, 15
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Aug 2024
- Study startOct 2023 (estimated)
- Primary completionSep 2024 (estimated)
- Study completionOct 2024 (estimated)
Why it stopped: varients of COVID-19 has changed
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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clover Biopharmaceuticals AUS Pty
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06567457
- Sponsor's protocol ID
- CLO-SCB-2023B-002
- Status last verified
- Aug 2024
- First submitted
- 23 Aug 2023
- Last updated
- 22 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 3, Multi-center, Observer-blind, Randomized, Controlled Study to Evaluate the Immunogenicity and Safety of Monovalent Omicron XBB.1.5 Vaccine Administered as a Booster Dose to Adults Who Previously Received COVID-19 Vaccine
- ClinicalTrials.gov ID
- NCT06567457
- Acronym / sponsor ID
- CLO-SCB-2023B-002
- Conditions
- COVID-19
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: varients of COVID-19 has changed
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Clover Biopharmaceuticals AUS PtyIndustry (pharma, biotech, devices)
- Study start
- Oct 2023 (estimated)
- Primary completion
- Sep 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 22 Aug 2024 (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 purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
Detailed description
The purpose of this study is to assess the immunogenicity and safety of SCB-2023B monovalent Omicron XBB.1.5 vaccine compared to the prototype SCB-2019 vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| SCB-2023B | Experimental | Biological: SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19Participants will receive one booster dose with SCB-2023B vaccine on Day 1 |
| SCB-2019 | Active comparator | Biological: SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19Participants will receive one booster dose with SCB-2019 vaccine on Day 1 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Male or female ≥18 years of age.
- Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
- Individuals willing and able to give an informed consent, prior to screening.
- Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
- Individuals who received three doses of inactivated COVID-19 vaccine
Key exclusion criteria (14 listed)
- Body temperature >37.8°C (axillary), or any acute illness at baseline.
- Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
- Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
- Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
- Any progressive unstable or uncontrolled clinical conditions.
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 |
|---|---|---|
| SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19intramuscular injection | Biological | SCB-2023B |
| SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19intramuscular injection | Biological | SCB-2019 |
Primary outcome
GMT ratio
Time frame: Day 15
Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine
Time frame: Day 7
Proportion of participants with local and systemic AEs
Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
Time frame: Day 29
Proportion of participants with unsolicited AEs
Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
Time frame: Up to 1 year post-vaccination
Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
9 secondary outcomes
Non-inferiority of the Omicron XBB.1.5 immune response elicited by SCB-2023B vaccine versus SARS-CoV-2 Delta titers in a subset of naïve participants of the CLO-SCB-2019-003 clinical study (virus neutralization assay)
Time frame: Day 15
GMTs
Time frame: Day 1, 15, 180
GMFRs
Time frame: Day 1, 15, 180
SCRs
Time frame: Day 1, 15, 180
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5
Time frame: Day 1, 15, 180
GMTs
Time frame: Day 1, 15
GMFRs
Time frame: Day 1, 15
SCRs
Time frame: Day 1, 15
Proportion of subjects with antibody titer >=LLOQ
Time frame: Day 1, 15
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Aug 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 3 study testing SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 and SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 in people with COVID-19, run by Clover Biopharmaceuticals AUS Pty.
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 5 inclusion and 14 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: withdrawn, as of the sponsor's last update on 22 Aug 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 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
GMT ratio (time frame: Day 15). The study lists 4 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 22 Aug 2024; AzTrials last refreshed its copy on 7 Nov 2026.