COVID-19
Conditions
Brief summary
The purpose of this study is to assess the immunogenicity and safety of SCB-2023 trivalent vaccine compared to the prototype SCB-2019 monovalent vaccine in participants previously vaccinated with 3 doses of inactivated COVID-19 vaccine ≥6 months prior to enrollment.
Interventions
BIOLOGICALSCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
BIOLOGICALSCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection
SCB-2019 (monovalent), a recombinant 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 |
|---|---|---|
| To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5 | Day 15 | GMT ratio |
| Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine | Day 7 | Proportion of participants with local and systemic AEs |
| Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine | Day 29 | Proportion of participants with unsolicited AEs |
| To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5 | Day 15 | GMT ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 | Day 1, 15, 180 | Proportion of participants with antibody titer ≥ LLoQ |
| Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern | Day 1, 15 | GMTs |
| Non-inferiority with respect to ratio of the geometric mean of Omicron BA.5 titer in SCB-2023 recipients and SARS-CoV-2 Delta titers in SCB-2019 recipients, as measured by virus neutralization assay. | Day 15 | GMT ratio |
| Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern | Day 1, 15 | SCRs |
| Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern | Day 1, 15 | Proportion of participants with antibody titer ≥ LLoQ |
| Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern | Day 1, 15 | GMFRs |
| Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5. | Day 1, 15, 180 | GMTs; GMFRs; SCRs; Proportion of participants with antibody titer ≥ LLoQ |
| Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 | Day 1, 15, 180 | GMFRs |
| Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 | Day 1, 15, 180 | SCRs |
Countries
Philippines
Outcome results
None listed