Protective Immunity Project 02

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.

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Key information

Conditions

Kidney Transplant Immunology Immunosuppression

Age range

18 year–59 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Emory University

Atlanta, Georgia, 30322, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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.

Exclusion criteria

Patients with evidence of an active systemic infection

Treatment and study plan

Primary outcomes

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
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
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

Sponsors and collaborators

Lead sponsor

Emory University

Other

Registry information

Official study 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

Acronym: PIP-02

Important dates

Study start: 2006
Primary completion: 2010
Study completion: 2011
First posted: Feb 2, 2009
Registry last updated: Nov 25, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed