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varients of COVID-19 has changed
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCB-2023B | Experimental | Participants will receive one booster dose with SCB-2023B vaccine on Day 1 |
|
| SCB-2019 | Active Comparator | Participants will receive one booster dose with SCB-2019 vaccine on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCB-2023B vaccine, a monovalent Omicron XBB.1.5 recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 | Biological | intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT ratio | Demonstrate that SCB-2023B vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5 | Day 15 |
| Assess the reactogenicity of SCB-2023B vaccine compared to SCB-2019 vaccine | Proportion of participants with local and systemic AEs | Day 7 |
| Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine | Proportion of participants with unsolicited AEs | Day 29 |
| Assess the safety of SCB-2023B vaccine compared to SCB-2019 vaccine | Proportion of participants with SAE, AEs leading to early termination from study, MAAEs, and AESIs | Up to 1 year post-vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | GMT ratio | Day 15 |
| GMTs |
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Inclusion Criteria:
Exclusion Criteria:
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| SCB-2019 vaccine, a monovalent wu-hu1 SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19 | Biological | intramuscular injection |
|
Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5
| Day 1, 15, 180 |
| GMFRs | Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron XBB.1.5 | Day 1, 15, 180 |
| SCRs | Proportion of subjects with seroconversion by virus neutralization assay against Omicron XBB1.5 | Day 1, 15, 180 |
| Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron XBB1.5 | Proportion of participants with antibody titer ≥ LLoQ | Day 1, 15, 180 |
| GMTs | Geometric mean titers elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains | Day 1, 15 |
| GMFRs | Geometric mean fold rise elicited by SCB-2023B vaccine and SCB-2019 vaccine by virus neutralization assay against new emergent SARS-CoV-2 strains | Day 1, 15 |
| SCRs | Proportion of subjects with seroconversion by virus neutralization assay against new emergent SARS-CoV-2 strains | Day 1, 15 |
| Proportion of subjects with antibody titer >=LLOQ | Proportion of participants with antibody titer ≥ LLoQ by virus neutralization assay against new emergent SARS-CoV-2 strains | Day 1, 15 |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000721887 | SCB-2019 COVID-19 vaccine |
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