Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers
Study Details
Study Description
Brief Summary
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 |
|---|---|---|
|
N/A |
Detailed Description
OBJECTIVES:
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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.
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To correlate influenza infection with graft-vs-host disease, age, and transplant type in these patients.
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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 Design
Outcome Measures
Primary Outcome Measures
- Incidence of influenza infection in patients and healthy volunteers []
Secondary Outcome Measures
- Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients []
- Vaccine protection []
Eligibility Criteria
Criteria
DISEASE CHARACTERISTICS:
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Meets 1 of the following:
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Patient at City of Hope or Kaiser hospital who underwent prior autologous or allogeneic matched-related hematopoietic stem cell transplantation (HSCT) or matched-unrelated HSCT for treatment of hematological malignancies, including aplastic anemia or myelodysplastic syndromes
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Must agree to return to City of Hope for screening every 2-4 weeks during the flu season
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100-365 days post-transplant
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Any prior therapy allowed
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Employee volunteer from the City of Hope who agrees to have a nasopharyngeal wash performed at General Clinical Research Center every 2 weeks during the flu season
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Must be eligible (per physicians instructions) and vaccinated during the 2008-2009 or 2009-2010 flu season
PATIENT CHARACTERISTICS:
- Life expectancy > 9 months
PRIOR CONCURRENT THERAPY:
- See Disease Characteristics
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | City of Hope Comprehensive Cancer Center | Duarte | California | United States | 91010-3000 |
Sponsors and Collaborators
- City of Hope Medical Center
- National Cancer Institute (NCI)
Investigators
- Principal Investigator: Aprille Seidel, PhD, City of Hope Comprehensive Cancer Center
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 08121
- P30CA033572
- CHNMC-08121