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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00551837
Other study ID # 2006-12-14
Secondary ID
Status Completed
Phase N/A
First received October 30, 2007
Last updated October 20, 2017
Start date November 2006
Est. completion date May 2008

Study information

Verified date October 2017
Source The Cleveland Clinic
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 82
Est. completion date May 2008
Est. primary completion date April 2008
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
n/a

Sponsors (2)

Lead Sponsor Collaborator
The Cleveland Clinic University Hospitals Cleveland Medical Center
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