Protective Immunity Project 02 (PIP-02)

Emory University

Status: Completed

Conditions: Immunology; Kidney Transplant; Immunosuppression

Study type: Observational

Funder types: Other

Identifiers

NCT00833651

IRB00024793

PIP-02 (Other Identifier)

Details and patient eligibility

About

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.

Enrollment: 97 patients

Sex: All

Ages: 18 to 59 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

97 participants in 3 patient groups

tacrolimus

Description:

Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus

sirolimus

Description:

Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing sirolimus

Healthy controls

Description:

Age, gender- and race-matched individuals, not on immunosuppressive medications