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