Clinical Trial: Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers
Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional
Official Title: Clinical Correlates of Immunologic Responses to the Flu Vaccine
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 Summary:
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.
Sponsor: City of Hope Medical Center
Current Primary Outcome: Incidence of influenza infection in patients and healthy volunteers
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients
- Vaccine protection
Original Secondary Outcome: Same as current
Information By: City of Hope Medical Center
Dates:
Date Received: August 4, 2009
Date Started: November 2008
Date Completion:
Last Updated: June 3, 2015
Last Verified: June 2015