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

Lymphoma Clinical Trial

Official title:

Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00964821
• Other study ID #: 06157
• Secondary ID: P30CA033572CHNMC
• Status: Completed
• Phase: N/A
• First received: August 22, 2009
• Last updated: November 3, 2017
• Start date: January 2007
• Est. completion date: May 2013

Study information

• Verified date: November 2017
• Source: City of Hope Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

RATIONALE: Studying immune response to flu vaccine in patients who have undergone a stem cell transplant may help doctors plan the best treatment.

PURPOSE: This clinical trial is studying flu vaccine to see how well it works in preventing infection in patients who have undergone a stem cell transplant and in healthy volunteers.

Description:

OBJECTIVES:

• Examine the humoral and cellular memory immune responses to influenza immunization in patients who have undergone autologous or allogeneic hematologic stem cell transplantation.

• Examine the impact of graft-vs-host disease on immune reconstitution and vaccine response in these patients.

• Examine the impact of age ≥ 60 years on immune reconstitution after vaccination in these patients.

• Examine and compare the cellular memory immune response to influenza immunization in healthy volunteers versus the response in these patients.

• Examine the differences between CD8, CD4, and antibody response to circulating flu strains compared to immune response to flu vaccination in immunized vs non-immunized patients who were transplanted at a similar time and from the same transplant source.

OUTLINE: This is a multicenter study. Patients are stratified according to transplantation type and response (allogeneic HCT with no acute or chronic GVHD vs allogeneic HCT with acute or chronic GVHD vs autologous HCT) and patient age (≥ 60 years vs < 60 years).

Beginning 100-364 days post-transplantation patients receive vaccine to immunize against influenza A serotypes specific for influenza seasons 2006-2008, and/or vaccine to immunize against influenza A and B serotypes specific for influenza seasons 2009-2011. Healthy participants receive vaccine to immunize against influenza A serotypes specific for influenza season 2007-2008.

Blood samples from patients and healthy participants are collected at baseline and at days 30, 90, 180, and 360 post-vaccination for humoral immunity and antibody analysis by ELISA and hemagglutination-inhibition test (HAI) testing.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 459
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

• Patient at the City of Hope or Kaiser hospital who underwent prior autologous or allogeneic matched-related hematologic stem cell transplantation (HSCT) or matched-unrelated HSCT for treatment of hematological malignancies, including aplastic anemia or myelodysplastic syndromes

• Eligible (in accordance with physician's recommendation) to receive the vaccine influenza A serotypes specific for the 2006-2007 or 2007-2008 influenza season

• Eligible (in accordance with physician's recommendation) to receive the vaccine influenza A or B serotypes specific for the 2009-2010 or 2010-2011 influenza season

• Patients who are not vaccinated are followed under the study protocol once they are matched to a vaccinated patient on the date of transplant and source of transplant

• All HLA serotypes allowed

• Employee volunteer from the City of Hope

• Meets the requirements for influenza vaccination

• Eligible to receive the CDC recommended vaccine for influenza A serotypes specific for the 2007-2008 flu season as part of occupational health's vaccination initiative

• All HLA serotypes allowed

PATIENT CHARACTERISTICS:

• Life expectancy > 9 months

• No HIV seropositivity

• No hepatitis B or C seropositivity

• Hepatitis B-positive serology by vaccination allowed

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics

• No prior influenza vaccination after transplantation

Related Conditions & MeSH terms

• Chronic Myeloproliferative Disorders
• Leukemia
• Lymphoma
• Multiple Myeloma
• Multiple Myeloma and Plasma Cell Neoplasm
• Myelodysplastic Syndromes
• Myelodysplastic-Myeloproliferative Diseases
• Myelodysplastic/Myeloproliferative Neoplasms
• Myeloproliferative Disorders
• Neoplasms
• Neoplasms, Plasma Cell
• Nonmalignant Neoplasm
• Plasmacytoma
• Preleukemia
• Syndrome

Intervention

Biological:
• trivalent influenza vaccine
Patients or normal volunteers who will be vaccinated against the flu.

Other:
• Immunoenzyme technique
This test will determine the level of antibodies in participants who have been vaccinated against the flu and those who have not been vaccinated against the flu.
• Laboratory biomarker analysis
This test will count the number of T cells (the cells that kill the flu virus) in participants who have been vaccinated against the flu and those who have not been vaccinated against the flu.

Locations

Country	Name	City	State
United States	City of Hope Comprehensive Cancer Center	Duarte	California
United States	City of Hope Medical Group	Pasadena	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	Humoral and cellular memory immune responses in patients and healthy volunteers		At Day 0 and 30, 90 and 180 days after vaccine in healthy participants and also at 360 days in transplant patients . 4-5 times in the first 2 years after transplant for transplant patients not vaccinated. One time in normal participants not vaccinated.
Secondary	Incidence rate of influenza or respiratory incidence in patients after vaccination		1 year after vaccination or two years after transplant if not vaccinated.
Secondary	Impact of graft-vs-host disease on immune reconstitution and vaccine response		1 year after vaccination or two years after transplant if not vaccinated.
Secondary	Impact of age = 60 years on immune reconstitution of after vaccination		1 year after vaccination or two years after transplant if not vaccinated.
Secondary	Differences between antibody and cytokine (CD8 and CD4) response		180 days after vaccine in healthy participants. 360 days after vaccine in transplant patients. 2 years after transplant for transplant patients not vaccinated. One time in normal participants not vaccinated.