Immune Response to Influenza Vaccination - Full Text View

Immune Response to Influenza Vaccination

This study has been completed.

Sponsors and Collaborators:	The Cleveland Clinic University Hospitals of Cleveland
Information provided by:	The Cleveland Clinic
ClinicalTrials.gov Identifier:	NCT00551837

Purpose

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.

Condition

Solid Organ Transplantation
Chronic Kidney Disease

MedlinePlus related topics:

Flu

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Prospective

Official Title:	Immune Response to Influenza Vaccination

Further study details as provided by The Cleveland Clinic:

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	350
Study Start Date:	November 2006
Study Completion Date:	May 2008
Primary Completion Date:	April 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

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

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00551837

Locations


United States, Ohio
	Univesity Hospitals of Cleveland
	Cleveland, Ohio, United States, 44106

Sponsors and Collaborators

The Cleveland Clinic

University Hospitals of Cleveland

Investigators


Study Director:	Emilio Poggio, MD	Cleveland Clinic

More Information

Study ID Numbers:	2006-12-14
First Received:	October 30, 2007
Last Updated:	May 5, 2008
ClinicalTrials.gov Identifier:	NCT00551837
Health Authority:	Institutional Review Board: United States

Keywords provided by The Cleveland Clinic:

Lung Transplantation

Kidney Transplnatation

Chroinic Kidney Disease

Influenza

Study placed in the following topic categories:

Virus Diseases

Renal Insufficiency

Urologic Diseases

Respiratory Tract Diseases

Respiratory Tract Infections

Renal Insufficiency, Chronic

Kidney Failure, Chronic

Influenza, Human

Orthomyxoviridae Infections

Kidney Diseases

Kidney Failure

Additional relevant MeSH terms:

RNA Virus Infections

ClinicalTrials.gov processed this record on October 17, 2008