Immunogenicity and Safety Study of SCB-2023 Vaccine as a Booster in Adults
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 3 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: SCB-2023 arm Participants will receive one booster dose with SCB-2023 vaccine on Day 1 |
Biological: SCB-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
|
| Active Comparator: SCB-2019 arm Participants will receive one booster dose with SCB-2019 vaccine on Day 1 |
Biological: SCB-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
|
Outcome Measures
Primary Outcome Measures
- To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5 [Day 15]
GMT ratio
- 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
- Assess the safety of SCB-2023 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
- 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
- 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
- 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
- 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
- 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
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Male or female ≥18 years of age.
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Individuals willing and able to comply with study requirements, including all scheduled visits, vaccinations, laboratory tests and other study procedures.
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Individuals willing and able to give an informed consent, prior to screening.
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Healthy participants or participants with pre-existing medical conditions who are in a stable medical condition.
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Individuals who received three doses of inactivated COVID-19 vaccine.
Exclusion Criteria:
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Body temperature >37.8°C (axillary), or any acute illness at baseline.
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Confirmed SARS-CoV-2 infectionor with known history of COVID-19.
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Individuals who have received an investigational or licensed COVID-19 vaccine prior to Day 1 (except for inactivated COVID-19 vaccine).
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Any confirmed or suspected immunosuppressive or immunodeficient condition resulting from disease or immunosuppressive/cytotoxic therapy.
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Any progressive unstable or uncontrolled clinical conditions.
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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.
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History of malignancy within 1 year before screening.
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Individuals who have received any other investigational product.
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Individuals who have received any other licensed vaccines within 14 days prior to enrollment.
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Treatment with Rituximab or any other anti-CD20 monoclonal antibodies.
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Known bleeding disorder that would, in the opinion of the investigator, contraindicate i.m. injection.
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Administration of intravenous immunoglobulins and/or any blood products.
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Any condition that, in the opinion of the investigator, would interfere with the primary study objectives or pose additional risk to the participant.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Health Index Multispecialty Clinic | Manila | Philippines | ||
| 2 | Manila Doctors Hospital | Manila | Philippines | ||
| 3 | Tropical Disease Foundation | Putatan | Philippines |
Sponsors and Collaborators
- Clover Biopharmaceuticals AUS Pty Ltd
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- CLO-SCB-2023-002