Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation
18 Years
N/A
Both
Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms, Nonmalignant Neoplasm
Trial Information
Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation
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.
Inclusion Criteria
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Outcome Measure:
Humoral and cellular memory immune responses in patients and healthy volunteers
Outcome 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.
Safety Issue:
No
Principal Investigator
Don Diamond, PhD
Investigator Role:
Principal Investigator
Investigator Affiliation:
City of Hope Medical Center
Authority:
United States: Institutional Review Board
Study ID:
06157
NCT ID:
NCT00964821
Start Date:
January 2007
Completion Date:
Related Keywords:
- Chronic Myeloproliferative Disorders
- Leukemia
- Lymphoma
- Multiple Myeloma and Plasma Cell Neoplasm
- Myelodysplastic Syndromes
- Myelodysplastic/Myeloproliferative Neoplasms
- Nonmalignant Neoplasm
- stage III adult Burkitt lymphoma
- stage III adult diffuse large cell lymphoma
- stage III adult diffuse mixed cell lymphoma
- stage III adult diffuse small cleaved cell lymphoma
- stage III adult Hodgkin lymphoma
- stage III adult immunoblastic large cell lymphoma
- stage III adult lymphoblastic lymphoma
- stage III grade 1 follicular lymphoma
- stage III grade 2 follicular lymphoma
- stage III grade 3 follicular lymphoma
- stage III mantle cell lymphoma
- stage III marginal zone lymphoma
- stage III small lymphocytic lymphoma
- stage IV adult Burkitt lymphoma
- stage IV adult diffuse large cell lymphoma
- stage IV adult diffuse mixed cell lymphoma
- stage IV adult diffuse small cleaved cell lymphoma
- stage IV adult Hodgkin lymphoma
- stage IV adult immunoblastic large cell lymphoma
- stage IV adult lymphoblastic lymphoma
- stage IV grade 1 follicular lymphoma
- stage IV grade 2 follicular lymphoma
- stage IV grade 3 follicular lymphoma
- stage IV mantle cell lymphoma
- stage IV marginal zone lymphoma
- stage IV small lymphocytic lymphoma
- recurrent adult Burkitt lymphoma
- recurrent adult diffuse large cell lymphoma
- recurrent adult diffuse mixed cell lymphoma
- recurrent adult diffuse small cleaved cell lymphoma
- recurrent adult Hodgkin lymphoma
- recurrent adult immunoblastic large cell lymphoma
- recurrent adult lymphoblastic lymphoma
- recurrent childhood large cell lymphoma
- recurrent cutaneous T-cell non-Hodgkin lymphoma
- recurrent grade 1 follicular lymphoma
- recurrent grade 2 follicular lymphoma
- recurrent grade 3 follicular lymphoma
- recurrent mantle cell lymphoma
- recurrent marginal zone lymphoma
- recurrent small lymphocytic lymphoma
- recurrent mycosis fungoides/Sezary syndrome
- extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue
- nodal marginal zone B-cell lymphoma
- splenic marginal zone lymphoma
- noncontiguous stage II adult Burkitt lymphoma
- noncontiguous stage II adult diffuse large cell lymphoma
- noncontiguous stage II adult diffuse mixed cell lymphoma
- noncontiguous stage II adult diffuse small cleaved cell lymphoma
- noncontiguous stage II adult immunoblastic large cell lymphoma
- noncontiguous stage II adult lymphoblastic lymphoma
- noncontiguous stage II grade 1 follicular lymphoma
- noncontiguous stage II grade 2 follicular lymphoma
- noncontiguous stage II grade 3 follicular lymphoma
- noncontiguous stage II mantle cell lymphoma
- noncontiguous stage II marginal zone lymphoma
- noncontiguous stage II small lymphocytic lymphoma
- accelerated phase chronic myelogenous leukemia
- adult acute lymphoblastic leukemia in remission
- adult acute myeloid leukemia in remission
- 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)
- atypical chronic myeloid leukemia, BCR-ABL negative
- blastic phase chronic myelogenous leukemia
- chronic myelomonocytic leukemia
- chronic phase chronic myelogenous leukemia
- recurrent adult acute lymphoblastic leukemia
- recurrent adult acute myeloid leukemia
- refractory chronic lymphocytic leukemia
- refractory hairy cell leukemia
- relapsing chronic myelogenous leukemia
- secondary acute myeloid leukemia
- stage III chronic lymphocytic leukemia
- stage IV chronic lymphocytic leukemia
- chronic eosinophilic leukemia
- primary myelofibrosis
- chronic neutrophilic leukemia
- de novo myelodysplastic syndromes
- myelodysplastic/myeloproliferative neoplasm, unclassifiable
- previously treated myelodysplastic syndromes
- secondary myelodysplastic syndromes
- stage I multiple myeloma
- stage II multiple myeloma
- stage III multiple myeloma
- refractory multiple myeloma
- aplastic anemia
- Neoplasms
- Influenza, Human
- Leukemia
- Lymphoma
- Lymphoma, Non-Hodgkin
- Multiple Myeloma
- Neoplasms, Plasma Cell
- Plasmacytoma
- Myelodysplastic Syndromes
- Preleukemia
- Myeloproliferative Disorders
- Lymphoma, Large-Cell, Immunoblastic
- Myelodysplastic-Myeloproliferative Diseases
Name | Location |
|---|---|
| City of Hope Comprehensive Cancer Center | Duarte, California 91010 |
| City of Hope Medical Group | Pasadena, California 91105 |
