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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00952185
Recruitment Status : Terminated (Very low enrollment and follow-up, cannot meet study objectives)
First Posted : August 6, 2009
Last Update Posted : June 8, 2015
National Cancer Institute (NCI)
Information provided by (Responsible Party):
City of Hope Medical Center

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.

Condition or disease Intervention/treatment Phase
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 Other: cytology specimen collection procedure Other: fluorescent antibody technique Procedure: assessment of therapy complications Not Applicable

Detailed Description:


  • 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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 9 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Correlates of Immunologic Responses to the Flu Vaccine
Study Start Date : November 2008
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Primary Outcome Measures :
  1. Incidence of influenza infection in patients and healthy volunteers

Secondary Outcome Measures :
  1. Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients
  2. Vaccine protection

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes


  • 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


  • Life expectancy > 9 months


  • See Disease Characteristics

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00952185

United States, California
City of Hope Comprehensive Cancer Center
Duarte, California, United States, 91010-3000
Sponsors and Collaborators
City of Hope Medical Center
National Cancer Institute (NCI)
Principal Investigator: Aprille Seidel, PhD City of Hope Comprehensive Cancer Center

Responsible Party: City of Hope Medical Center Identifier: NCT00952185     History of Changes
Other Study ID Numbers: 08121
P30CA033572 ( U.S. NIH Grant/Contract )
First Posted: August 6, 2009    Key Record Dates
Last Update Posted: June 8, 2015
Last Verified: June 2015

Keywords provided by City of Hope Medical Center:
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)
atypical chronic myeloid leukemia, BCR-ABL negative
blastic phase chronic myelogenous leukemia
chronic myelomonocytic leukemia
chronic phase chronic myelogenous leukemia
mast cell leukemia
meningeal chronic myelogenous leukemia
progressive hairy cell leukemia, initial treatment
prolymphocytic leukemia
recurrent adult acute lymphoblastic leukemia
recurrent adult acute myeloid leukemia
recurrent adult T-cell leukemia/lymphoma
refractory chronic lymphocytic leukemia
refractory hairy cell leukemia
relapsing chronic myelogenous leukemia
secondary acute myeloid leukemia
stage 0 chronic lymphocytic leukemia
stage I adult T-cell leukemia/lymphoma
stage I chronic lymphocytic leukemia
stage II adult T-cell leukemia/lymphoma

Additional relevant MeSH terms:
Multiple Myeloma
Neoplasms, Plasma Cell
Myelodysplastic Syndromes
Nervous System Neoplasms
Central Nervous System Neoplasms
Myeloproliferative Disorders
Lymphoproliferative Disorders
Myelodysplastic-Myeloproliferative Diseases
Virus Diseases
Neoplasms by Histologic Type
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Pathologic Processes
Hemostatic Disorders
Vascular Diseases
Cardiovascular Diseases
Blood Protein Disorders
Hematologic Diseases
Hemorrhagic Disorders
Bone Marrow Diseases
Precancerous Conditions