COVID-19
Conditions
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.
Interventions
BIOLOGICALSCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
intramuscular injection
BIOLOGICALSCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19
intramuscular injection
Sponsors
Clover Biopharmaceuticals AUS Pty
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 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
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GMT ratio | 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 | Day 7 | Proportion of participants with local and systemic AEs |
| Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine | Day 29 | Proportion of participants with unsolicited AEs |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| SCRs | Day 1, 15, 180 | Proportion of subjects with seroconversion by virus neutralization assay against Omicron XBB1.5 |
| 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 |
| 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 |
| 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 |
| GMTs | Day 1, 15, 180 | Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5 |
| GMFRs | Day 1, 15, 180 | Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5 |
Outcome results
None listed