Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients
NCT ID: NCT01215734
Last Updated: 2013-03-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE1
44 participants
INTERVENTIONAL
2010-10-31
2012-09-30
Brief Summary
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* Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplant recipients.
Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine.
* Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell transplant recipients influenza virus antigens included in trivalent influenza vaccine after high dose or standard dose trivalent influenza vaccine.
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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High-Dose Trivalent Inactivated Influenza Vaccine
Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
0.5 ml of HD-TIV on visit 1
Standard dose Trivalent Inactivated Flu Vaccine
Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine.
Standard Dose Trivalent Inactivated Flu Vaccine
Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
Interventions
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High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)
0.5 ml of HD-TIV on visit 1
Standard Dose Trivalent Inactivated Flu Vaccine
Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
Eligibility Criteria
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Inclusion Criteria
* greater than or equal to 18 years of age
* Available for duration of study
* If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses will be eligible.
Exclusion Criteria
* History of Guillain-Barre syndrome
* Evidence of hematologic malignancy or disease relapse post-transplant (mixed chimerisms and molecular evidence of disease is permitted)
* Non-allogeneic (e.g. autologous) hematopoietic SCT recipients
* History of receiving 2011 - 2012 influenza vaccine
* History of proven influenza disease after September 1, 2011.
* Pregnant females
* Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol
* Have any condition that the investigator believes may interfere with successful completion of the study
* Platelet count less than 50,000 cells/μL
* History of known infection with HIV, Hepatitis B or Hepatitis C
* History of known latex hypersensitivity
18 Years
ALL
No
Sponsors
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Vanderbilt-Ingram Cancer Center
OTHER
Responsible Party
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Natasha Halasa, MD
Assistant Professor of Pediatrics, Pediatric Infectious Diseases
Principal Investigators
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Natasha Halasa, M.D., M.P.H.
Role: PRINCIPAL_INVESTIGATOR
Vanderbilt University
Locations
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Vanderbilt-Ingram Cancer Center, Clinical Trials Information Program
Nashville, Tennessee, United States
Countries
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Related Links
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Vanderbilt-Ingram Cancer Center, Find a Clinical Trial
Other Identifiers
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100980
Identifier Type: OTHER
Identifier Source: secondary_id
100980
Identifier Type: OTHER
Identifier Source: secondary_id
VICC BMT 1057
Identifier Type: -
Identifier Source: org_study_id
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