Clinical trial NCT00833651: Protective Immunity Project 02
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Transplant
Immunology
Immunosuppression
Keywords: Transplant
Immunology
Immunosuppression
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2009-02-02
Enrollment: 97
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult (ages 18-59) recipients of deceased or living donor renal transplants

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.


Eligibility 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

Primary outcomes:
measure: To determine the effect of immunosuppressive regimens on the magnitude and character of the adaptive immune response to flu vaccine
timeFrame: 7, 14, 28 and 90 days post vaccination
measure: To determine the effects of chronic immunosuppressive therapies on innate immunity during response to flu vaccine
timeFrame: 7, 14, 28 and 90 days post vaccination
measure: To define the transcriptional and protein signatures of the response to flu vaccination in patients on conventional immunosuppressive regimens compared to healthy volunteers
timeFrame: 7, 14, 28 and 90 days post vaccination
Secondary outcomes:
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Emory University
state: Georgia
Study officials:
affiliation: Emory University
name: Christian P. Larsen, MD, DPhil
role: PRINCIPAL_INVESTIGATOR
affiliation: Emory University
name: Kenneth E Kokko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: