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funding lost
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| Name | Class |
|---|---|
| ViraCor Laboratories | INDUSTRY |
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50 end-stage renal disease (ESRD) patients whom have had at least 2 doses of messenger ribonucleic acid (mRNA) vaccine, and undergoing transplantation at the University of Alabama at Birmingham (UAB) will be enrolled. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.
50 ESRD patients on peritoneal dialysis or hemodialysis or not on immunosuppression, no prior transplant, no known history of COVID infection, whom have had at least 2 doses of mRNA vaccine, and undergoing transplantation at UAB will be enrolled, after signing the informed consent. The third mRNA vaccine will be given 3 months post transplant, and the 4th mRNA vaccine will be given 3 months following this. Blood samples will be collected and shipped to Viracor on day of transplant, and at months 1, 3, 4, 6, and 12 for spike protein and t cell assay.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Coronavirus (COVID-19) SARS-CoV-2 inSIGHTâ„¢ T Cell Immunity Test | Diagnostic Test | Boosters will be given after month 3 after transplant, and the 2nd booster will be given 3 months after the first. |
|
| Measure | Description | Time Frame |
|---|---|---|
| COVID spike protein Immunoglobulin G (IgG) and Tcell assay | transplant patient response to vaccine compared to response of patients not on immunosuppression | pre-transplant |
| COVID spike protein IgG and Tcell assay | transplant patient response to vaccine compared to response of patients not on immunosuppression | month 1 |
| COVID spike protein IgG and Tcell assay | transplant patient response to vaccine compared to response of patients not on immunosuppression | month 3 |
| COVID spike protein IgG and Tcell assay | transplant patient response to vaccine compared to response of patients not on immunosuppression | month 4 |
| COVID spike protein IgG and Tcell assay | transplant patient response to vaccine compared to response of patients not on immunosuppression | month 6 |
| COVID spike protein IgG and Tcell assay | transplant patient response to vaccine compared to response of patients not on immunosuppression | month 12 |
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Inclusion Criteria:
Exclusion Criteria:
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patients planning on having a renal transplant at the University of Alabama at Birmingham
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| Name | Affiliation | Role |
|---|---|---|
| Graham C Towns, MD | University of Alabama at Birmingham | Principal Investigator |
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| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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blood samples will be collected for spike protein antibodies and t cell assays
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| 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 |