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we has selected a new candidate vaccine which is monovalent.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SCB-2023 arm | Experimental | Participants will receive one booster dose with SCB-2023 vaccine on Day 1 |
|
| SCB-2019 arm | Active Comparator | Participants will receive one booster dose with SCB-2019 vaccine on Day 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection | Biological | SCB-2023 vaccine (trivalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection |
| Measure | Description | Time Frame |
|---|---|---|
| To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron BA.5 | GMT ratio | Day 15 |
| To demonstrate that SCB-2023 vaccine elicits an immune response superior to SCB-2019 for Omicron XBB.1.5 | GMT ratio | Day 15 |
| Assess the reactogenicity of SCB-2023 vaccine compared to SCB-2019 vaccine | Proportion of participants with local and systemic AEs | Day 7 |
| Assess the safety of SCB-2023 vaccine compared to SCB-2019 vaccine | Proportion of participants with unsolicited AEs | Day 29 |
| Assess the safety of SCB-2023 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 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. | GMT ratio | Day 15 |
| Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Health Index Multispecialty Clinic | Manila | Philippines | ||||
| Manila Doctors Hospital |
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| SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection | Biological | SCB-2019 (monovalent), a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection |
|
GMTs; GMFRs; SCRs; Proportion of participants with antibody titer ≥ LLoQ |
| Day 1, 15, 180 |
| 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 | GMFRs | Day 1, 15, 180 |
| Proportion of subjects with seroconversion by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 | SCRs | Day 1, 15, 180 |
| Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against Omicron BA.5 and Omicron XBB1.5 | Proportion of participants with antibody titer ≥ LLoQ | Day 1, 15, 180 |
| Geometric mean titers elicited by SCB-2023 vaccine and SCB-2019 vaccine by virus neutralization assay against SARS-CoV-2 variants of concern | GMTs | Day 1, 15 |
| Geometric mean fold rise elicited by SCB-2023 vaccine and SCB-2019 vaccines by virus neutralization assay against SARS-CoV-2 variants of concern | GMFRs | Day 1, 15 |
| Proportion of subjects with seroconversion by virus neutralization assay against SARS-CoV-2 variants of concern | SCRs | Day 1, 15 |
| Proportion of subjects with antibody titer >=LLOQ by virus neutralization assay against SARS-CoV-2 variants of concern | Proportion of participants with antibody titer ≥ LLoQ | Day 1, 15 |
| Manila |
| Philippines |
| Tropical Disease Foundation | Putatan | Philippines |
| 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 |
|---|---|
| D007273 | Injections, Intramuscular |
| C000721887 | SCB-2019 COVID-19 vaccine |
| ID | Term |
|---|---|
| D007267 | Injections |
| D004333 | Drug Administration Routes |
| D004358 | Drug Therapy |
| D013812 | Therapeutics |
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