Flu Vaccine in Preventing Influenza Infection in Healthy Volunteers and in Patients Who Have Undergone Stem Cell Transplant
NCT ID: NCT00964821
Last Updated: 2017-11-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
459 participants
OBSERVATIONAL
2007-01-31
2013-05-31
Brief Summary
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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.
Detailed Description
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* 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.
Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Flu vaccine
Patients and normal volunteers who have received a flu vaccine
trivalent influenza vaccine
Patients or normal volunteers who will be vaccinated against the flu.
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.
Non-vaccine
Patients and normal volunteers who have not received the flu vaccine
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.
Interventions
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trivalent influenza vaccine
Patients or normal volunteers who will be vaccinated against the flu.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
18 Years
120 Years
ALL
Yes
Sponsors
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National Cancer Institute (NCI)
NIH
City of Hope Medical Center
OTHER
Responsible Party
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Principal Investigators
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Don Diamond, PhD
Role: PRINCIPAL_INVESTIGATOR
City of Hope Medical Center
Locations
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City of Hope Comprehensive Cancer Center
Duarte, California, United States
City of Hope Medical Group
Pasadena, California, United States
Countries
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Other Identifiers
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CHNMC-06157
Identifier Type: -
Identifier Source: secondary_id
CDR0000652790
Identifier Type: REGISTRY
Identifier Source: secondary_id
06157
Identifier Type: -
Identifier Source: org_study_id