Immunogenicity and Safety Study of Monovalent Omicron XBB.1.5 Vaccine as a Booster in Adults
- Conditions
- COVID-19
- Registration Number
- NCT06567457
- Lead Sponsor
- Clover Biopharmaceuticals AUS Pty Ltd
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Withdrawn
- Sex
- All
- Target Recruitment
- 0
Inclusion Criteria:<br><br> - Male or female =18 years of age.<br><br> - Individuals willing and able to comply with study requirements, including all<br> scheduled visits, vaccinations, laboratory tests and other study procedures.<br><br> - Individuals willing and able to give an informed consent, prior to screening.<br><br> - Healthy participants or participants with pre-existing medical conditions who are in<br> a stable medical condition.<br><br> - Individuals who received three doses of inactivated COVID-19 vaccine<br><br>Exclusion Criteria:<br><br> - Body temperature >37.8°C (axillary), or any acute illness at baseline.<br><br> - Confirmed SARS-CoV-2 infectionor with known history of COVID-19.<br><br> - Individuals who have received an investigational or licensed COVID-19 vaccine prior<br> to Day 1 (except for inactivated COVID-19 vaccine).<br><br> - Any confirmed or suspected immunosuppressive or immunodeficient condition resulting<br> from disease or immunosuppressive/cytotoxic therapy.<br><br> - Any progressive unstable or uncontrolled clinical conditions.<br><br> - Individuals who are pregnant, or breastfeeding, or planning to become pregnant while<br> enrolled in this study or during the study period.<br><br> - History of severe adverse reaction associated with a vaccine or severe allergic<br> reaction.<br><br> - History of malignancy within 1 year before screening.<br><br> - Individuals who have received any other investigational product.<br><br> - Individuals who have received any other licensed vaccines within 14 days prior to<br> enrollment.<br><br> - Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.<br><br> - Known bleeding disorder that would, in the opinion of the investigator,<br> contraindicate i.m. injection.<br><br> - Administration of intravenous immunoglobulins and/or any blood products.<br><br> - Any condition that, in the opinion of the investigator, would interfere with the<br> primary study objectives or pose additional risk to the participant.
Not provided
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method GMT ratio;Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine;Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine;Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine
- Secondary Outcome Measures
Name Time Method 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);GMTs;GMFRs;SCRs;Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5;GMTs;GMFRs;SCRs;Proportion of subjects with antibody titer >=LLOQ