Immune Response to Influenza Vaccination

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

82 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-11-30

Study Completion Date

2008-05-31

Brief Summary

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The purpose of this study is to evaluate the immune response to a routine influenza vaccination. Influenza vaccination is given as part of routine standard of care in these individuals and is not part of the study protocol. The study will evaluate for a change in response to common antigens over time after influenza vaccination to determine if changes are related to the development of chronic rejection after solid-organ transplantation. We hypothesize that the influenza vaccine contributes to the alloreactivity of T cells verses common HLA types in the donor pool.

Detailed Description

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Conditions

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Solid Organ Transplantation Chronic Kidney Disease

Keywords

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Lung Transplantation Kidney Transplnatation Chroinic Kidney Disease Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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Inclusion Criteria

* Transplant recipients (lung or kidney) 18 years or older, more than 3 months after transplantation
* Transplant candidates (kidney) 18 years or older, to recieve influenza vaccination
* Healthy volunteers to receive influenza vaccination

Exclusion Criteria

* Under 18 years of age
* Pregnant
* Medical contraindication for vaccine
* Transplant recipients receiving acute rejection therapy within one month
* Healthy volunteers with autoimmune disease or medications to mediate immune function
* Receipt of live, attenuated influenza vaccine, instead of injectable vaccine

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Emilio Poggio, MD

Role: STUDY_DIRECTOR

The Cleveland Clinic

Countries

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United States

Other Identifiers

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2006-12-14

Identifier Type: -

Identifier Source: org_study_id