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

Lymphoma Clinical Trial

Official title:

Clinical Correlates of Immunologic Responses to the Flu Vaccine

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00952185
• Other study ID #: 08121
• Secondary ID: P30CA033572CHNMC
• Status: Terminated
• Phase: N/A
• First received: August 4, 2009
• Last updated: June 3, 2015
• Start date: November 2008
• Est. completion date: June 2010

Study information

• Verified date: June 2015
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Brain and Central Nervous System Tumors
• Central Nervous System Neoplasms
• Chronic Myeloproliferative Disorders
• Disease
• Leukemia
• Lymphoma
• Lymphoproliferative Disorder
• Lymphoproliferative Disorders
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Nervous System Neoplasms
• Nonmalignant Neoplasm
• Plasmacytoma
• Preleukemia
• Viral Infection
• Virus Diseases

Intervention

Other:
• cytology specimen collection procedure

• fluorescent antibody technique

Procedure:
• assessment of therapy complications

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California

Sponsors (2)

Lead Sponsor	Collaborator
City of Hope Medical Center	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of influenza infection in patients and healthy volunteers			No
Secondary	Correlation of influenza infection with graft-vs-host disease, age, and transplant type in patients			No
Secondary	Vaccine protection			No