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| ID | Type | Description | Link |
|---|---|---|---|
| PIP-02 | Other Identifier | Other |
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Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6 months post-transplant. The influenza vaccine stimulates the immune system to builds protective antibodies against the flu virus.
Previous research has shown that adult kidney transplant patients are not able to form as much of these protective antibodies as compared to healthy volunteers. Research has also suggested that different immunosuppressive medicines may have different effects on antibody formation. In this study, we hope to evaluate these differences in more detail.
In recent years, increasingly effective, but also increasingly complex, immunosuppressive regimens have been developed, however, there has been little detailed systematic study of the immune changes that occur in response to vaccination with these newer immunosuppressive regimens.Current policies on vaccination of transplant recipients are generic and continue to be based on old concepts rather than on any new understanding of the effects of these newer therapies on the immune system.
We hope to improve our understanding of the effects of the immunosuppressive regimens in use today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting desirable immune responses while not causing rejection.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tacrolimus | Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus | ||
| sirolimus | Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing sirolimus | ||
| Healthy controls | Age, gender- and race-matched individuals, not on immunosuppressive medications |
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| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of immunosuppressive regimens on the magnitude and character of the adaptive immune response to flu vaccine | 7, 14, 28 and 90 days post vaccination | |
| To determine the effects of chronic immunosuppressive therapies on innate immunity during response to flu vaccine | 7, 14, 28 and 90 days post vaccination | |
| To define the transcriptional and protein signatures of the response to flu vaccination in patients on conventional immunosuppressive regimens compared to healthy volunteers | 7, 14, 28 and 90 days post vaccination |
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Inclusion Criteria:
Exclusion Criteria:
1. Patients with evidence of an active systemic infection
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Adult (ages 18-59) recipients of deceased or living donor renal transplants
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| Name | Affiliation | Role |
|---|---|---|
| Christian P. Larsen, MD, DPhil | Emory University | Principal Investigator |
| Kenneth E Kokko, MD, PhD | Emory University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Emory University | Atlanta | Georgia | 30322 | United States |
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serum, PBMCs