Protective Immunity Project 02 (PIP-02)

Study Description

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief Summary:

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.

Condition or disease
Kidney Transplant; Immunology; Immunosuppression

Study Design

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Observational
Actual Enrollment :	97 participants
Observational Model:	Cohort
Time Perspective:	Prospective
Official Title:	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
Study Start Date :	November 2006
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	October 2011

Groups and Cohorts

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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

Outcome Measures

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. To determine the effect of immunosuppressive regimens on the magnitude and character of the adaptive immune response to flu vaccine [ Time Frame: 7, 14, 28 and 90 days post vaccination ]
2. To determine the effects of chronic immunosuppressive therapies on innate immunity during response to flu vaccine [ Time Frame: 7, 14, 28 and 90 days post vaccination ]
3. To define the transcriptional and protein signatures of the response to flu vaccination in patients on conventional immunosuppressive regimens compared to healthy volunteers [ Time Frame: 7, 14, 28 and 90 days post vaccination ]

Biospecimen Retention:   Samples Without DNA

serum, PBMCs

Eligibility Criteria

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	18 Years to 59 Years (Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Adult (ages 18-59) recipients of deceased or living donor renal transplants

Criteria

Inclusion Criteria:

1. Male or female patients between 18 and 59 years of age
2. Greater than six months post deceased or living donor renal transplant
3. Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
4. Patients with no known contraindications to flu vaccine (e.g. egg allergy, prior serious adverse reaction to flu vaccine, current febrile illness, marked leukopenia (WBC < 2500 cells/ml)
5. Women of childbearing potential must have a negative serum pregnancy test within 7 days of study enrollment and must not be breast-feeding.

Exclusion Criteria:

1. Patients with evidence of an active systemic infection

Contacts and Locations

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Georgia
Emory University
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Emory University

Investigators

Principal Investigator:	Christian P. Larsen, MD, DPhil	Emory University
Principal Investigator:	Kenneth E Kokko, MD, PhD	Emory University

More Information

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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Christian P Larsen, MD, PhD, Chairman, Dept. of Surgery, Emory University
ClinicalTrials.gov Identifier:	NCT00833651 History of Changes
Other Study ID Numbers:	IRB00024793; PIP-02 ( Other Identifier: Other )
First Posted:	February 2, 2009
Last Update Posted:	November 25, 2013
Last Verified:	November 2013

Keywords provided by Christian P Larsen, MD, PhD, Emory University:

Transplant; Immunology; Immunosuppression