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| Name | Class |
|---|---|
| Coalition for Epidemic Preparedness Innovations | OTHER |
| International Vaccine Institute | OTHER |
| GlaxoSmithKline | INDUSTRY |
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This is a Phase III, randomized, placebo-controlled, observer-blinded, parallel-group, multi-center study to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of SK SARS-CoV-2 recombinant protein nanoparticle vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.
The purpose of this study is to assess the safety, reactogenicity, and immunogenicity of heterologous booster vaccination of a SARS-CoV-2 Recombinant Protein Nanoparticle Vaccine (GBP510) adjuvanted with AS03 in adults aged 18 years and older.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Primary series of mRNA-1273 manufactured by ModernaTX, Inc. | Experimental | participants who received primary vaccination of a mRNA-1273 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine). |
|
| Primary series of mRNA-1273 manufactured by ModernaTX, Inc. (Placebo) | Placebo Comparator | participants who received primary vaccination of a mRNA-1273 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive placebo. |
|
| Primary series of ChAdOx1 nCOV-19 manufactured by Astrazeneca or S.I of India Pvt., Ltd. | Experimental | participants who received primary vaccination of a ChAdOx1 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine). |
|
| Primary series of ChAdOx1 nCOV-19 manufactured by Astrazeneca or S.I of India Pvt., Ltd. (Placebo) | Placebo Comparator | participants who received primary vaccination of a ChAdOx1 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GBP510 adjuvanted with AS03 | Biological | injection volume of 0.5mL on Day 0 |
|
| Measure | Description | Time Frame |
|---|---|---|
| GMFR (Geometric Mean Fold Rise) of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from baseline(Visit 2) to2 weeks post heterologous booster vaccinationfor each cohort | For all cohort | 2 weeks post heterologous booster vaccination for eachcohort |
| Measure | Description | Time Frame |
|---|---|---|
| GMT of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay at each time point post heterologous booster vaccination. | For all cohort | Through Day 365 post vaccination |
| GMFR of neutralizing antibody to SARS-CoV-2 measured by wild-type virus neutralization assay from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Santa K Das, MD | Institute of Medicine (IOM). | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Policlínico Social Del Norte | Bogotá | Bogota D.C. | 1008 | Colombia | ||
| CAIMED (Centro de Atención e Investigación Médica) |
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| A single dose vaccination of Ad26.COV2.S manufactured by Janssen Pharmaceuticals/Johnson & Johnson | Experimental | participants who received primary vaccination of a Ad26.COV2.S at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine). |
|
| A single dose vaccination of Ad26.COV2.S manufactured by Janssen Pharmaceuticals/J&J (Placebo) | Placebo Comparator | participants who received primary vaccination of a Ad26.COV2.S at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive Placebo. |
|
| Primary series of BNT162b2 manufactured by Pfizer/BioNTech | Active Comparator | participants who received primary vaccination of a BNT162b2 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine). |
|
| Primary series of BNT162b2 manufactured by Pfizer/BioNTech (Placebo) | Placebo Comparator | participants who received primary vaccination of a BNT162b2 at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive placebo. |
|
| Primary series of BBIBP-CorV manufactured by Sinopharm | Experimental | participants who received primary vaccination of a BBIBP-CorV at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine). |
|
| Primary series of BBIBP-CorV manufactured by Sinopharm (Placebo) | Placebo Comparator | participants who received primary vaccination of a BBIBP-CorV at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive placebo |
|
| Primary series of CoronaVac | Active Comparator | participants who received primary vaccination of a CoronaVac at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose of GBP510 adjuvanted with AS03 (Test Vaccine). |
|
| Primary series of CoronaVac (Placebo) | Placebo Comparator | participants who received primary vaccination of a CoronaVac at least 12 weeks prior to study vaccination will be enrolled and block-randomized in 6:1 ratio to receive one dose Placebo |
|
| Placebo (Normal Saline) | Other | injection volume of 0.5mL on Day 0 |
|
For all cohort |
| Through Day 365 post vaccination |
| Percentage of participants with ≥4-fold rise in wild-type virus neutralizing antibody titer to SARS-CoV-2 from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination. | For all cohort | Through Day 365 post vaccination |
| GMT of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA at each time point post heterologous booster vaccination | For all cohort | Through Day 365 post vaccination |
| GMFR of SARS-CoV-2 RBD-binding IgG antibody measured by ELISA from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination | For all cohort | Through Day 365 post vaccination |
| Percentage of participants with ≥4-fold rise in ELISA SARS-CoV-2 RBD-binding IgG titer from baseline (Visit 2) to each subsequent time point post heterologous booster vaccination. | For all cohort | Through Day 365 post vaccination |
| Cell-mediated response for both Th1 and Th2 cytokines measured by ELISpot and/or FluoroSpot, and for both CD4+ and CD8+ T-cells measured by FACS | For all cohort (in a subset of participants) | Through Day 365 post vaccination |
| Occurrence of immediate systemic reactions in 30 minutes post heterologous booster vaccination. | For all cohort | Through 30 minutes post booster vaccination |
| Occurrence of solicited local/systemic Adverse Events(AEs) | For all cohort | Through 7 days post booster vaccination |
| Occurrence of unsolicited AEs | For all cohort | Through 28 days post booster vaccination |
| Occurrence of SAEs, MAAEs, AEs leading to study withdrawal, and AESIs during the whole study period. | Through 7 days post booster vaccination | Through Day 365 post booster vaccination |
| Chía |
| Cundinamarca |
| Colombia |
| Dhulikhel | Kathmandu | Dhulikhel | 45200 | Nepal |
| Institute of Medicine (IOM) | Kathmandu | Maharajgunj | 44600 | Nepal |
| 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 |
|---|---|
| C000718742 | GBP510 vaccine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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