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CompletedNCT01149382Updated Aug 21, 2012

Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

An observational study in Transplant, sponsored by University of Alberta. Completed at 1 site in Canada. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2012-08-21.

Sponsored by University of Alberta · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
61
Ages
18 Years to 75 Years
Sex
All
01

Study 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

Read the 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.
02

Conditions studied

  • Transplant

Keywords

  • flu shot
  • islet cell transplant recipients
03

In context

Lead sponsor

University of Alberta is the lead sponsor of 800 studies on the registry; 168 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult islet cell transplant recipients

Inclusion criteria

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

Exclusion criteria

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
61 participants (actual)

Groups and cohorts

  • islet cell transplant recipients
06

What researchers measure

Primary outcomes

  1. •Seroprotection rate

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

    Time frame: 3 months

Secondary outcomes

  1. •Seroconversion rate

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

    Time frame: 3 months

07

Study locations

1 site
  • University of Alberta Hospital
    Edmonton, Alberta T6G 2E1, Canada
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 21, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01149382
Lead sponsor
University of Alberta
Responsible party
Deepali Kumar (Assistant Professor, University of Alberta) — Principal investigator
First posted
Jun 23, 2010
Start date
Aug 2010
Primary completion
Aug 2011
Completion
Dec 2011
Last update
Aug 21, 2012

Study contacts

Deepali Kumar, MD
principal investigator · University of Alberta

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.

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