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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00833651
Other study ID # IRB00024793
Secondary ID PIP-02
Status Completed
Phase N/A
First received January 30, 2009
Last updated November 21, 2013
Start date November 2006
Est. completion date October 2011

Study information

Verified date November 2013
Source Emory University
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 97
Est. completion date October 2011
Est. primary completion date February 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 59 Years
Eligibility 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

Study Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Locations

Country Name City State
United States Emory University Atlanta Georgia

Sponsors (1)

Lead Sponsor Collaborator
Emory University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary To determine the effects of chronic immunosuppressive therapies on innate immunity during response to flu vaccine 7, 14, 28 and 90 days post vaccination No
Primary 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 No
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