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Randomized-controlled trial comparing homologous (mRNA vaccine) vs. heterologous (vector vaccine) for third SARS-CoV-2 vaccine dose in kidney transplant recipients not responding to initial prime-boost vaccination with an mRNA vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| homologous 3rd vaccination (mRNA vaccine) | Active Comparator | Participants will receive a third SARS-CoV-2 vaccination with the same mRNA vaccine they received for the initial prime-boost vaccination (BNT162b2 or mRNA-1273 ) |
|
| heterologous 3rd vaccination (vector vaccine) | Experimental | participants will receive a third SARS-CoV-2 vaccination with a vector vaccine (Ad26COVS1 or ChAdOx1-S) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ad26COVS1 | Drug | Heterologous vaccination |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion at 4 weeks | number of patients developing SARS-CoV-2 antibodies at 4 weeks after 3rd vaccination | 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion at 12 weeks | number of patients developing SARS-CoV-2 antibodies at 12 weeks after 3rd vaccination (> 0.8 BAU/mL) | 3 months |
| SARS-CoV-2 antibody levels at 4 weeks | SARS-CoV-2 antibody levels at 4 weeks after the third vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medicial University of Vienna | Vienna | 1090 | Austria |
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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 |
|---|---|
| D000090984 | Ad26COVS1 |
| D000090982 | BNT162 Vaccine |
| D000090983 | 2019-nCoV Vaccine mRNA-1273 |
| ID | Term |
|---|---|
| D000086663 | COVID-19 Vaccines |
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
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| ChAdOx1 SARS2 Vaccine |
| Drug |
Heterologous vaccination |
|
| BNT162B2 | Drug | Homologous vaccination |
|
| mRNA-1273 | Drug | Homologous vaccination |
|
| 4 weeks |
| SARS-CoV-2 antibody levels at 12 weeks | SARS-CoV-2 antibody levels at 12 weeks after the third vaccination | 3 months |
| Seroconversion at 36 weeks | number of patients developing SARS-CoV-2 antibodies at 36 weeks after 3rd vaccination (> 0.8 BAU/mL) | 6 months |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D045424 |
| Complex Mixtures |
| D000087503 | mRNA Vaccines |
| D000087504 | Nucleic Acid-Based Vaccines |
| D014614 | Vaccines, Synthetic |
| D011994 | Recombinant Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000941 | Antigens |
| D001685 | Biological Factors |