Protective Immunity Project 02 - Full Text View

Sponsored by:	Emory University
Information provided by:	Emory University
ClinicalTrials.gov Identifier:	NCT00833651

Purpose

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
Kidney Transplant Immunology Immunosuppression

Study Type:	Observational
Study Design:	Cohort, 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

Resource links provided by NLM:

MedlinePlus related topics: Flu Kidney Transplantation

U.S. FDA Resources

Further study details as provided by Emory University:

Primary Outcome Measures:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples Without DNA

Biospecimen Description:

serum, PBMCs

Estimated Enrollment:	100
Study Start Date:	November 2006
Estimated Study Completion Date:	September 2010
Estimated Primary Completion Date:	September 2010 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Eligibility

Ages Eligible for Study:	18 Years to 59 Years
Genders Eligible for Study:	Both
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:

Male or female patients between 18 and 59 years of age
Greater than six months post deceased or living donor renal transplant
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.
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)
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00833651

Contacts

Contact: Beth Begley, RN	404-712-1114	beth.begley@emoryhealthcare.org
Contact: Sumeet Bahl	404-712-1114	sbahl2@emory.edu

Locations

United States, Georgia
Emory University	Recruiting
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

No publications provided

Responsible Party:	Emory University ( Christian P. Larsen, MD, DPhil )
Study ID Numbers:	PIP-02
Study First Received:	January 30, 2009
Last Updated:	January 30, 2009
ClinicalTrials.gov Identifier:	NCT00833651 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Emory University:

Transplant
Immunology
Immunosuppression

Study placed in the following topic categories:

Influenza, Human
Healthy

ClinicalTrials.gov processed this record on August 28, 2009