- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00964821
Flu Vaccine in Preventing Influenza Infection in Healthy Volunteers and in Patients Who Have Undergone Stem Cell Transplant
Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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California
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Duarte, California, United States, 91010-3000
- City of Hope Comprehensive Cancer Center
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Pasadena, California, United States, 91105
- City of Hope Medical Group
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
Flu vaccine
Patients and normal volunteers who have received a flu vaccine
|
Patients or normal volunteers who will be vaccinated against the flu.
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.
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.
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Non-vaccine
Patients and normal volunteers who have not received the flu vaccine
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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.
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Humoral and cellular memory immune responses in patients and healthy volunteers
Time Frame: 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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Incidence rate of influenza or respiratory incidence in patients after vaccination
Time Frame: 1 year after vaccination or two years after transplant if not vaccinated.
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1 year after vaccination or two years after transplant if not vaccinated.
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Impact of graft-vs-host disease on immune reconstitution and vaccine response
Time Frame: 1 year after vaccination or two years after transplant if not vaccinated.
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1 year after vaccination or two years after transplant if not vaccinated.
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Impact of age ≥ 60 years on immune reconstitution of after vaccination
Time Frame: 1 year after vaccination or two years after transplant if not vaccinated.
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1 year after vaccination or two years after transplant if not vaccinated.
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Differences between antibody and cytokine (CD8 and CD4) response
Time Frame: 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.
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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.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Don Diamond, PhD, City of Hope Medical Center
Study record dates
Study Major Dates
Study Start
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
- primary myelofibrosis
- stage III adult diffuse large cell lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult Burkitt lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult Burkitt lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult Burkitt lymphoma
- recurrent childhood large cell lymphoma
- chronic myelomonocytic leukemia
- de novo myelodysplastic syndromes
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- adult acute myeloid leukemia with 11q23 (MLL) abnormalities
- adult acute myeloid leukemia with inv(16)(p13;q22)
- adult acute myeloid leukemia with t(15;17)(q22;q12)
- adult acute myeloid leukemia with t(16;16)(p13;q22)
- adult acute myeloid leukemia with t(8;21)(q22;q22)
- secondary acute myeloid leukemia
- chronic phase chronic myelogenous leukemia
- recurrent adult acute myeloid leukemia
- adult acute myeloid leukemia in remission
- recurrent adult Hodgkin lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- blastic phase chronic myelogenous leukemia
- relapsing chronic myelogenous leukemia
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage III mantle cell lymphoma
- stage IV mantle cell lymphoma
- stage II multiple myeloma
- stage III multiple myeloma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- noncontiguous stage II marginal zone lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- stage III small lymphocytic lymphoma
- stage III marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- stage IV marginal zone lymphoma
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- stage I multiple myeloma
- recurrent adult lymphoblastic lymphoma
- recurrent mantle cell lymphoma
- aplastic anemia
- refractory chronic lymphocytic leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- stage III adult Hodgkin lymphoma
- stage IV adult Hodgkin lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- stage III adult lymphoblastic lymphoma
- stage IV adult lymphoblastic lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- refractory multiple myeloma
- recurrent adult acute lymphoblastic leukemia
- refractory hairy cell leukemia
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- chronic eosinophilic leukemia
- chronic neutrophilic leukemia
- atypical chronic myeloid leukemia, BCR-ABL negative
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
Additional Relevant MeSH Terms
- Pathologic Processes
- Cardiovascular Diseases
- Vascular Diseases
- Immune System Diseases
- Neoplasms by Histologic Type
- Lymphoproliferative Disorders
- Lymphatic Diseases
- Immunoproliferative Disorders
- Disease
- Bone Marrow Diseases
- Hematologic Diseases
- Hemorrhagic Disorders
- Hemostatic Disorders
- Paraproteinemias
- Blood Protein Disorders
- Precancerous Conditions
- Neoplasms
- Lymphoma
- Syndrome
- Myelodysplastic Syndromes
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Leukemia
- Preleukemia
- Plasmacytoma
- Myeloproliferative Disorders
- Myelodysplastic-Myeloproliferative Diseases
Other Study ID Numbers
- 06157
- P30CA033572 (U.S. NIH Grant/Contract)
- CHNMC-06157
- CDR0000652790 (REGISTRY: NCI PDQ)
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