Study Results
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View full resultsBasic Information
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TERMINATED
NA
68 participants
INTERVENTIONAL
2010-09-30
2011-06-30
Brief Summary
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This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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Participants Receiving 1 Dose of Vaccine
Control group participants (healthy volunteers):
* Age 18 to 50 years
* No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
* No flu vaccine in previous 4 months
and/or HSCT recipients who are greater than 60 days post transplant.
Influenza vaccine
One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Participants Receiving 2 Doses of Vaccine
Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant.
Influenza vaccine
Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Interventions
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Influenza vaccine
One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Influenza vaccine
Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HSCT recipients who are greater than 60 days post transplant.
* Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant
* Show neutrophil recovery, platelet count \> 50,000/mm3 (may be transfused), no known disease relapse
* No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
* No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months
* Controls:
* Age 18 to 50 years
* No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
* No flu vaccine in previous 4 months
6 Months
ALL
Yes
Sponsors
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Masonic Cancer Center, University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Michael Verneris, M.D.
Role: PRINCIPAL_INVESTIGATOR
Masonic Cancer Center, University of Minnesota
Locations
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Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, United States
Countries
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Related Links
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Randomized Trial of One versus Two Doses of Influenza Vaccine after Allogeneic Transplantation
Other Identifiers
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MT2010-08R
Identifier Type: OTHER
Identifier Source: secondary_id
1007M86296
Identifier Type: OTHER
Identifier Source: secondary_id
2010NTLS050
Identifier Type: -
Identifier Source: org_study_id