Immune Response to Influenza Vaccine in Islet Cell Transp... | NCT01149382

Studies
Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients

NCT01149382

Sponsor

University of Alberta

Status

Completed

Last Update Posted

Aug 21, 2012Estimated

Enrollment

61Actual

Phase

Not provided

Conditions

Transplant

Interventions

Not provided

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2012

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2010

Primary Completion Date

Aug 2011Actual

Completion Date

Dec 2011Actual

First Submitted Date

Jun 22, 2010

First Submission Date that Met QC Criteria

Jun 22, 2010

First Posted Date

Jun 23, 2010Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 17, 2012

Last Update Posted Date

Aug 21, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

61Actual

Label	Type	Description	Intervention Names
islet cell transplant recipients

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Adult islet cell transplant recipients

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Deepali Kumar, MD	University of Alberta	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Alberta Hospital		Edmonton	Alberta	T6G 2E1	Canada

Condition Browse Module

MeSH Terms

ID	Term
D007251	Influenza, Human

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D009976	Orthomyxoviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided