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

Sponsor

City of Hope Medical Center (Other)

Overall Status

Completed

CT.gov ID

NCT00964821

Collaborator

National Cancer Institute (NCI) (NIH)

459

Enrollment

Locations

Duration (Months)

229.5

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Nonmalignant Neoplasm	Biological: trivalent influenza vaccine Other: Immunoenzyme technique Other: Laboratory biomarker analysis

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

459 participants

Observational Model:

Case-Control

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Jan 1, 2007

Actual Primary Completion Date :

May 1, 2013

Actual Study Completion Date :

May 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Flu vaccine Patients and normal volunteers who have received a flu vaccine	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. Other: 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.
Non-vaccine Patients and normal volunteers who have not received the flu vaccine	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. Other: 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.

Arm

Intervention/Treatment

Flu vaccine

Patients and normal volunteers who have received a flu vaccine

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.

Other: 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.

Non-vaccine

Patients and normal volunteers who have not received the flu vaccine

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.

Other: 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.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

Incidence rate of influenza or respiratory incidence in patients after vaccination [1 year after vaccination or two years after transplant if not vaccinated.]
Impact of graft-vs-host disease on immune reconstitution and vaccine response [1 year after vaccination or two years after transplant if not vaccinated.]
Impact of age ≥ 60 years on immune reconstitution of after vaccination [1 year after vaccination or two years after transplant if not vaccinated.]
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.]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 120 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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