NCT00551837

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
82

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Nov 2006

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2006

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

October 30, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 31, 2007

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2008

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2008

Completed
Last Updated

October 24, 2017

Status Verified

October 1, 2017

Enrollment Period

1.4 years

First QC Date

October 30, 2007

Last Update Submit

October 20, 2017

Conditions

Keywords

Lung TransplantationKidney TransplnatationChroinic Kidney DiseaseInfluenza

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Lung and kidney transplant recipients, patients with chronic kidney disease and healthy controls

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Renal Insufficiency, ChronicInfluenza, Human

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRespiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Emilio Poggio, MD

    The Cleveland Clinic

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2007

First Posted

October 31, 2007

Study Start

November 1, 2006

Primary Completion

April 1, 2008

Study Completion

May 1, 2008

Last Updated

October 24, 2017

Record last verified: 2017-10