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

City of Hope

Status

Terminated

Conditions

Multiple Myeloma and Plasma Cell Neoplasm

Nonmalignant Neoplasm

Brain and Central Nervous System Tumors

Lymphoproliferative Disorder

Chronic Myeloproliferative Disorders

Lymphoma

Viral Infection

Leukemia

Myelodysplastic Syndromes

Myelodysplastic/Myeloproliferative Neoplasms

Treatments

Other: fluorescent antibody technique

Other: cytology specimen collection procedure

Procedure: assessment of therapy complications

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT00952185

08121

P30CA033572 (U.S. NIH Grant/Contract)

CHNMC-08121

Details and patient eligibility

About

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.

Full 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.

Enrollment

9 patients

Sex

All

Ages

18+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion 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