Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients
This study has been completed.
Sponsor:
University of Alberta
Information provided by (Responsible Party):
Deepali Kumar, University of Alberta
ClinicalTrials.gov Identifier:
NCT01149382
First received: June 22, 2010
Last updated: August 17, 2012
Last verified: August 2012
| Tracking Information | |||||
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| First Received Date ICMJE | June 22, 2010 | ||||
| Last Updated Date | August 17, 2012 | ||||
| Start Date ICMJE | August 2010 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
•Seroprotection rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] defined as a post-vaccination titer of ≥1:40 |
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| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT01149382 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
•Seroconversion rate [ Time Frame: 3 months ] [ Designated as safety issue: Yes ] defined as a 4-fold increase in titer from pre- to post-vaccination. |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Immune Response to Influenza Vaccine in Islet Cell Transplant Recipients | ||||
| Official Title ICMJE | Humoral Immune Response To Influenza Vaccine In Islet Cell In 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 |
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| Detailed Description | OBJECTIVE AND HYPOTHESIS
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| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Prospective |
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| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Non-Probability Sample | ||||
| Study Population | Adult islet cell transplant recipients |
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| Condition ICMJE | Transplant | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | islet cell transplant recipients | ||||
| Publications * | Not Provided | ||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 61 | ||||
| Completion Date | December 2011 | ||||
| Primary Completion Date | August 2011 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||
| Ages | 18 Years to 75 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | Canada | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01149382 | ||||
| Other Study ID Numbers ICMJE | KUOA-03-ITP | ||||
| Has Data Monitoring Committee | No | ||||
| Responsible Party | Deepali Kumar, University of Alberta | ||||
| Study Sponsor ICMJE | University of Alberta | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
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| Information Provided By | University of Alberta | ||||
| Verification Date | August 2012 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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