Clinical Correlates of Immunologic Responses to the Flu Vaccine
Trial Snapshot
- Phase
- Not Applicable
- Status
- Terminated
- Sponsor
- Enrollment
- 9
- Locations
- 1
- Primary Endpoint
- Incidence of influenza infection in patients and healthy volunteers
Study Overview
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.
Detailed Description
OBJECTIVES:
- 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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •DISEASE CHARACTERISTICS:
- •Meets 1 of the following:
- •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
- •Must agree to return to City of Hope for screening every 2-4 weeks during the flu season
- •100-365 days post-transplant
- •Any prior therapy allowed
- •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
- •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
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Incidence of influenza infection in patients and healthy volunteers
Secondary Outcomes
- Vaccine protection
- Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients