NCT01149382

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
61

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Aug 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 22, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 23, 2010

Completed
1 month until next milestone

Study Start

First participant enrolled

August 1, 2010

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2011

Completed
Last Updated

August 21, 2012

Status Verified

August 1, 2012

Enrollment Period

1 year

First QC Date

June 22, 2010

Last Update Submit

August 17, 2012

Conditions

Transplant

Keywords

flu shotislet cell transplant recipients

Outcome Measures

Primary Outcomes (1)

  • •Seroprotection rate

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

    3 months

Secondary Outcomes (1)

  • •Seroconversion rate

    3 months

Study Arms (1)

islet cell transplant recipients

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult islet cell transplant recipients

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Alberta Hospital

Edmonton, Alberta, T6G 2E1, Canada

Location

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Deepali Kumar, MD

    University of Alberta

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 22, 2010

First Posted

June 23, 2010

Study Start

August 1, 2010

Primary Completion

August 1, 2011

Study Completion

December 1, 2011

Last Updated

August 21, 2012

Record last verified: 2012-08

Locations

CA(1)