Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers
RATIONALE: The influenza vaccine may help prevent flu in patients who have undergone stem cell transplant.
PURPOSE: This clinical trial is studying how well the influenza vaccine works in preventing flu in patients who have undergone stem cell transplant and in healthy volunteers.
Brain and Central Nervous System Tumors
Chronic Myeloproliferative Disorders
Multiple Myeloma and Plasma Cell Neoplasm
Other: cytology specimen collection procedure
Other: fluorescent antibody technique
Procedure: assessment of therapy complications
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Clinical Correlates of Immunologic Responses to the Flu Vaccine|
- Incidence of influenza infection in patients and healthy volunteers [ Designated as safety issue: No ]
- Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients [ Designated as safety issue: No ]
- Vaccine protection [ Designated as safety issue: No ]
|Study Start Date:||November 2008|
|Study Completion Date:||June 2010|
|Primary Completion Date:||June 2010 (Final data collection date for primary outcome measure)|
- To examine the incidence rate of influenza infection over two flu seasons in patients who have undergone hematopoietic stem cell transplantation at the City of Hope National Medical Center.
- To correlate influenza infection with graft-vs-host disease, age, and transplant type in these patients.
- To examine and compare the incidence rate of influenza in healthy volunteers to the incidence rate in these patients.
OUTLINE: Beginning approximately 2 weeks after vaccination or the onset of flu season, patients and healthy participants undergo nasopharyngeal washes every 14-17 days (2-10 washes) during the months of November-March of the 2008-2009 and 2009-2010 flu seasons. Samples are analyzed by direct fluorescent antibodies.
Patients and participants complete case report forms detailing flu-like symptoms experienced in the 2 weeks before sample collection.
PROJECTED ACCRUAL: A total of 150 patients and 75 healthy volunteers will be accrued for this study.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00952185
|United States, California|
|City of Hope Comprehensive Cancer Center|
|Duarte, California, United States, 91010-3000|
|Principal Investigator:||Aprille Seidel, PhD||City of Hope Comprehensive Cancer Center|