Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers
Official Title
Clinical Correlates of Immunologic Responses to the Flu Vaccine
Acronym
Not provided
Organization
City of Hope Medical CenterOTHER
Status Module
Record Verification Date
Jun 2015
Overall Recruitment Status or Expanded Access Status
Terminated
Last Known Status
Not provided
Delayed Posting
Not provided
Why Stopped
Very low enrollment and follow-up, cannot meet study objectives
Expanded Access Info
No
Start Date
Nov 2008
Primary Completion Date
Jun 2010Actual
Completion Date
Jun 2010Actual
First Submitted Date
Aug 4, 2009
First Submission Date that Met QC Criteria
Aug 4, 2009
First Posted Date
Aug 6, 2009Estimated
Results Waived
Not provided
Results First Submitted Date
Not provided
Results First Submitted that Met QC Criteria
Not provided
Results First Posted Date
Not provided
Certification/Extension (aka Delayed Results) First Submitted Date
Not provided
Certification/Extension First Submitted that Passed QC Review
Not provided
Certification/Extension First Posted Date
Not provided
Last Update Submitted Date
Jun 3, 2015
Last Update Posted Date
Jun 8, 2015Estimated
Sponsor/Collaborators Module
Responsible Party, by Official Title
Sponsor
Lead Sponsor
City of Hope Medical CenterOTHER
Collaborators
Name
Class
National Cancer Institute (NCI)
NIH
Oversight Module
Has Data Monitoring Committee (DMC)
Yes
Is FDA Regulated Drug
Not provided
Is FDA Regulated Device
Not provided
Is Unapproved Device
Not provided
Pediatric Postmarket Surveillance of a Device Product
Not provided
Product Exported from US
Not provided
FDAAA801 Violation
Not provided
Description Module
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.
Conditions Module
Conditions
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
Keywords
viral infection
aplastic anemia
accelerated phase chronic myelogenous leukemia
acute undifferentiated leukemia
adult acute lymphoblastic leukemia in remission
adult acute myeloid leukemia in remission
adult acute myeloid leukemia with 11q23 (MLL) abnormalities
adult acute myeloid leukemia with inv(16)(p13;q22)
adult acute myeloid leukemia with t(15;17)(q22;q12)
adult acute myeloid leukemia with t(16;16)(p13;q22)
adult acute myeloid leukemia with t(8;21)(q22;q22)
Incidence of influenza infection in patients and healthy volunteers
Secondary Outcomes
Measure
Description
Time Frame
Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients
Vaccine protection
Other Outcomes
Not provided
Eligibility Module
Eligibility 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