Protective Immunity Project 02

NCT00833651 | Completed DMC

• 2 other identifiers: IRB00024793PIP-02
• Study Type: observational
• Target: 97
• Locations: 1 country
• Sites: 1

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.

Conditions

Kidney Transplant; Immunology; Immunosuppression

Keywords

Transplant; Immunology; Immunosuppression

Outcome Measures

Primary Outcomes (3)

• 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

• To determine the effects of chronic immunosuppressive therapies on innate immunity during response to flu vaccine

  7, 14, 28 and 90 days post vaccination

• 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

Study Arms (3)

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 Criteria

• Age: 18 Years - 59 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• \. Patients with evidence of an active systemic infection

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University

Atlanta, Georgia, 30322, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

serum, PBMCs

Study Officials

• Christian P. Larsen, MD, DPhil

  Emory University

  PRINCIPAL INVESTIGATOR

• Kenneth E Kokko, MD, PhD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chairman, Dept. of Surgery

Study Record Dates

• First Submitted: January 30, 2009
• First Posted: February 2, 2009
• Study Start: November 1, 2006
• Primary Completion: February 1, 2010
• Study Completion: October 1, 2011
• Last Updated: November 25, 2013

Record last verified: 2013-11

Locations

US (1)