Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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: November 21, 2013
Last verified: November 2013
  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: 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

Resource links provided by NLM:


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

serum, PBMCs


Enrollment: 97
Study Start Date: November 2006
Study Completion Date: October 2011
Primary Completion Date: February 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:

  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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

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

No publications provided

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
Study First Received: January 30, 2009
Last Updated: November 21, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Emory University:
Transplant
Immunology
Immunosuppression

ClinicalTrials.gov processed this record on November 20, 2014