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Protective Immunity Project 02 (PIP-02)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Christian P Larsen, MD, PhD, Emory University
ClinicalTrials.gov Identifier:
NCT00833651
First received: January 30, 2009
Last updated: March 29, 2012
Last verified: March 2012
History of Changes

January 30, 2009
March 29, 2012
November 2006
February 2010   (final data collection date for primary outcome measure)
  • 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 ]
Same as current
Complete list of historical versions of study NCT00833651 on ClinicalTrials.gov Archive Site
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Protective Immunity Project 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

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.
Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

serum, PBMCs
Non-Probability Sample

Adult (ages 18-59) recipients of deceased or living donor renal transplants
  • Kidney Transplant
  • Immunology
  • Immunosuppression
Not Provided
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
97
October 2011
February 2010   (final data collection date for primary outcome measure)

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
Both
18 Years to 59 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00833651
PIP-02
Yes
Christian P Larsen, MD, PhD, Emory University
Emory University
Not Provided
Principal Investigator: Christian P. Larsen, MD, DPhil Emory University
Principal Investigator: Kenneth E Kokko, MD, PhD Emory University
Emory University
March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP