PIP-02
A Prospective Comparison of the Magnitude and Character of the Immune Response to Influenza Vaccine in Immunosuppressed Renal Transplant Patients and Healthy Age-matched Volunteers
Sponsor study identifier
Secondary identifiers
OTHER · Other
observational
97
1 country
1
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2010
Actual (reported)Study Completion
October 2011
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 2011
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
January 30, 2009
Actual (reported)February 2, 2009
Actual (reported)February 2010
Actual (reported)October 2011
Actual (reported)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
Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus
Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing sirolimus
Age, gender- and race-matched individuals, not on immunosuppressive medications
Adult (ages 18-59) recipients of deceased or living donor renal transplants
Emory University
Atlanta, Georgia, 30322, United States
serum, PBMCs
Christian P. Larsen, MD, DPhil
Emory University
Kenneth E Kokko, MD, PhD
Emory University
97 participants (actual enrollment reported by the registry).
First Submitted
January 30, 2009
First Posted
February 2, 2009
Study Start
November 2006
Date type not reportedThis date has not been verified as actual or estimated.
Observational Registry Study of Renal Transplant Patients
Contact the study team to confirm eligibility.
Primary Completion
February 2010
Actual (reported)Study Completion
October 2011
Actual (reported)Last Updated
November 25, 2013
Record last verified: 2013-11
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