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Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers

This study has been terminated.
(Very low enrollment and follow-up, cannot meet study objectives)
Sponsor:
Collaborator:
Information provided by:
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00952185
First received: August 4, 2009
Last updated: March 3, 2011
Last verified: March 2011

August 4, 2009
March 3, 2011
November 2008
June 2010   (final data collection date for primary outcome measure)
Incidence of influenza infection in patients and healthy volunteers [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00952185 on ClinicalTrials.gov Archive Site
  • Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients [ Designated as safety issue: No ]
  • Vaccine protection [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Influenza Vaccine in Preventing Flu in Patients Who Have Undergone Stem Cell Transplant and in Healthy Volunteers
Clinical Correlates of Immunologic Responses to the Flu Vaccine

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.

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.

Interventional
Not Provided
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Brain and Central Nervous System Tumors
  • Chronic Myeloproliferative Disorders
  • Leukemia
  • Lymphoma
  • Lymphoproliferative Disorder
  • Multiple Myeloma and Plasma Cell Neoplasm
  • Myelodysplastic Syndromes
  • Myelodysplastic-Myeloproliferative Diseases
  • Nonmalignant Neoplasm
  • Virus Diseases
  • Other: cytology specimen collection procedure
  • Other: fluorescent antibody technique
  • Procedure: assessment of therapy complications
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
9
June 2010
June 2010   (final data collection date for primary outcome measure)

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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00952185
08121, P30CA033572, CHNMC-08121
Yes
Aprille Seidel, City of Hope Comprehensive Cancer Center
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Aprille Seidel, PhD Beckman Research Institute
City of Hope Medical Center
March 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP