Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
- Conditions
- COVID-19
- Interventions
- Biological: SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19Biological: SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
- Registration Number
- NCT06567457
- Lead Sponsor
- Clover Biopharmaceuticals AUS Pty Ltd
- Brief 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.
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description SCB-2019 SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 Participants will receive one booster dose with SCB-2019 vaccine on Day 1 SCB-2023B SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 Participants will receive one booster dose with SCB-2023B vaccine on Day 1
- Primary Outcome Measures
Name Time Method Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine Day 7 Proportion of participants with local and systemic AEs
GMT ratio Day 15 Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5
Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine Up to 1 year post-vaccination Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs
- Secondary Outcome Measures
Name Time Method SCRs Day 1, 15 Proportion of subjects with seroconversion by virus neutralization assay against new emergent SARS-CoV-2 strains
Proportion of subjects with antibody titer >=LLOQ Day 1, 15 Proportion of participants with antibody titer ≥ LLoQ by virus neutralization assay against new emergent SARS-CoV-2 strains
GMFRs Day 1, 15 Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains
Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5 Day 1, 15, 180 Proportion of participants with antibody titer ≥ LLoQ
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) Day 15 GMT ratio
GMTs Day 1, 15 Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains