Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

Humoral Immune Response To Influenza Vaccine In Islet Cell In Transplant Recipients

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01149382

Enrollment

Registered

2010-06-23

Start date

2010-08-31

Completion date

2011-12-31

Last updated

2012-08-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transplant

Keywords

flu shot, islet cell transplant recipients

Brief summary

Influenza virus is an important cause of morbidity in the transplant population and can lead to viral and bacterial pneumonia. Although the annual influenza vaccine is recommended for organ transplant patients, studies have shown that the standard inactivated influenza vaccine has poor immunogenicity in this population. The investigators plan to test the humoral response to vaccination and look at HLA upregulation

Detailed description

OBJECTIVE AND HYPOTHESIS * To test the specific humoral response of the influenza vaccine after islet cell transplantation * To test the production of HLA alloantibodies after vaccination.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Adult islet cell transplant recipients * Able to provide informed consent

Exclusion criteria

* Egg allergy * Previous life-threatening reaction to influenza vaccine (ie Guillain Barre Syndrome) * Febrile illness in the past two weeks * Unable to provide informed consent

Design outcomes

Primary

Measure	Time frame	Description
•Seroprotection rate	3 months	defined as a post-vaccination titer of ≥1:40

Secondary

Measure	Time frame	Description
•Seroconversion rate	3 months	defined as a 4-fold increase in titer from pre- to post-vaccination.

Countries

Canada

Outcome results