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The purpose of this study is to assess the immunogenicity and safety of the investigational SCB-2019 vaccine, administered as a booster dose, to adults who:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1a (primary series: Comirnaty) | Experimental | participants will receive one dose of SCB-2019 vaccine on Day 1 |
|
| Group 1b (primary series: Comirnaty) | Active Comparator | participants will receive one dose of Comirnaty vaccine on Day 1 |
|
| Group 2a (primary series: Vaxzevria) | Experimental | participants will receive one dose of SCB-2019 vaccine on Day 1 |
|
| Group 2b (primary series: Vaxzevria) | Active Comparator | participants will receive one dose of Vaxzevria vaccine on Day 1 |
|
| Group 3a (primary series: CoronaVac) | Experimental | participants will receive one dose of SCB-2019 vaccine on Day 1 |
|
| Group 3b (primary series: CoronaVac) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candidate vaccine, SCB-2019 | Biological | a recombinant SARS-CoV-2 trimeric S-protein subunit vaccine for COVID-19; intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMT ratio of GMT SCB-2019 over GMT Comirnaty on Day 15 | Day 15 | |
| GMT ratio of GMT SCB-2019 over GMT COVID-19 Vaccine Janssen on Day 15 | Day 15 | |
| GMT ratio of GMT SCB-2019 over GMT CoronaVac Vaccine on Day 15 | Day 15 | |
| Local and systemic solicited AEs reported within 7 days after study vaccination | Up to 7 days after each vaccination | |
| Unsolicited AEs reported from Visit 1 (Day 1) through Safety Call Day 29 | Up to Day 29 | |
| SAEs, AEs leading to early termination from the study, MAAEs, and AESIs | Through study completion, an average of 6 Months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Las Piñas Doctors Hospital | Las Piñas | National Capital Region | 1741 | Philippines | ||
| Manila Doctors Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37439701 | Derived | Roa CC Jr, de Los Reyes MRA, Plennevaux E, Smolenov I, Hu B, Gao F, Ilagan H, Ambrosino D, Siber G, Clemens R. Superior Boosting of Neutralizing Titers Against Omicron SARS-CoV-2 Variants by Heterologous SCB-2019 Vaccine vs a Homologous Booster in CoronaVac-Primed Adults. J Infect Dis. 2023 Nov 2;228(9):1253-1262. doi: 10.1093/infdis/jiad262. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| C000721887 | SCB-2019 COVID-19 vaccine |
| D000090985 | ChAdOx1 nCoV-19 |
| C000722216 | sinovac COVID-19 vaccine |
| ID | Term |
|---|---|
| D019444 | Vaccines, DNA |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D014612 | Vaccines |
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participants will receive one dose of CoronaVac vaccine on Day 1 |
|
| Group 4a (primary series and booster dose CoronaVac) | Experimental | participants will receive one dose of SCB-2019 vaccine on Day 1 |
|
| Group 4b (primary series and booster dose CoronaVac) | Active Comparator | participants will receive one dose of CoronaVac on Day 1; |
|
| Group 4c (primary series and booster dose CoronaVac) | Experimental | participants will receive a half dose of SCB-2019 vaccine on Day 1 |
|
| Group 5a (primary series: CoronaVac) | Experimental | participants will receive a dose of 2-vial presentation of SCB-2019 vaccine |
|
| Group 5b (primary series: CoronaVac) | Experimental | participants will receive a dose of 3-vial presentation of SCB-2019 vaccine |
|
| Comirnaty Vaccine | Biological | intramuscular injection |
|
| Vaxzevria Vaccine | Biological | intramuscular injection |
|
| CoronaVac Vaccine | Biological | intramuscular injection |
|
| Manila |
| National Capital Region |
| 1000 |
| Philippines |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D001688 |
| Biological Products |
| D045424 | Complex Mixtures |
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |