Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

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

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Key information

Conditions

Transplant Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alberta Hospital

Edmonton, Alberta, T6G 2E1, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

•Seroprotection rate

Time frame: 3 months

defined as a post-vaccination titer of ≥1:40

Secondary outcomes

•Seroconversion rate

Time frame: 3 months

defined as a 4-fold increase in titer from pre- to post-vaccination.

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Registry information

Official study title

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

Important dates

Study start: 2010
Primary completion: 2011
Study completion: 2011
First posted: Jun 23, 2010
Registry last updated: Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed