Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers
|ClinicalTrials.gov Identifier: NCT00952185|
Recruitment Status : Terminated (Very low enrollment and follow-up, cannot meet study objectives)
First Posted : August 6, 2009
Last Update Posted : June 8, 2015
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.
|Condition or disease||Intervention/treatment||Phase|
|Brain and Central Nervous System Tumors Chronic Myeloproliferative Disorders Leukemia Lymphoma Lymphoproliferative Disorder Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Nonmalignant Neoplasm Viral Infection||Other: cytology specimen collection procedure Other: fluorescent antibody technique Procedure: assessment of therapy complications||Not Applicable|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||9 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Primary Purpose:||Supportive Care|
|Official Title:||Clinical Correlates of Immunologic Responses to the Flu Vaccine|
|Study Start Date :||November 2008|
|Actual Primary Completion Date :||June 2010|
|Actual Study Completion Date :||June 2010|
- Incidence of influenza infection in patients and healthy volunteers
- Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients
- Vaccine protection
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|