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| Name | Class |
|---|---|
| CareDx | INDUSTRY |
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Immunocompromised individuals, such as solid organ transplant (SOT) recipients are at high risk of COVID-19 associated complications and mortality. Retrospective studies so far have shown that a majority of SOT recipients did not develop appreciable anti-spike antibody response after a first, second, or even third dose of mRNA vaccine. Treatment with antimetabolites was associated with poor vaccine response. The goal of this study is 1) examine whether transient immunosuppression reduction improves the immune response to a third dose of SARS-CoV-2 mRNA vaccine in kidney transplant recipients and 2) to assess the safety of immunosuppression reduction before and after third dose SARS-CoV-2 mRNA vaccination.
This is a prospective, randomized open-labeled study of kidney transplant recipients who have previously received two doses of mRNA COVID-19 vaccine (either BNT162b2, Pfizer-BioNTech or mRNA-1273, Moderna) and who are eligible to receive a 3rd dose of mRNA vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Immunosuppression reduction | Experimental | Reduction of immunosuppression before and after administration of a third dose of SARS-CoV-2 mRNA vaccine |
|
| Standard of care | No Intervention | No change to immunosuppression before or after receipt of a third dose of SARS-Co-2 mRNA vaccine |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Reduction in antimetabolite immunosuppression | Drug | Reduction in dose in mycophenolate mofetil/mycophenolic acid (MMF) or azathioprine before and after receiving 3rd dose vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Change in anti-SARS-CoV-2 IgG titer to SARS-CoV-2 target proteins from baseline | 6 weeks after receipt of 3rd dose mRNA vaccine | |
| Percentage of participants who achieve high-positive antibody titer | 6 weeks after receipt of 3rd dose mRNA vaccine |
| Measure | Description | Time Frame |
|---|---|---|
| Acute rejection | 1 week to 16 weeks after intervention | |
| De Novo donor specific antibody (DSA) development | 4 week to 16 weeks after intervention | |
| Change in donor-derived cell free DNA from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Davis | Sacramento | California | 95817 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 37382155 | Derived | Khan SF. Vaccination in kidney disease: what did we learn from COVID-19 pandemic. Curr Opin Nephrol Hypertens. 2023 Sep 1;32(5):412-417. doi: 10.1097/MNH.0000000000000901. Epub 2023 May 23. |
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Prospective randomized open-labeled
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| 1 week to 16 weeks after intervention |
| Change in glomerular filtration rate (GFR) from baseline | 1 week to 16 weeks after intervention |
| Change in proteinuria from baseline | 1 week to 16 weeks after intervention |
| 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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