Flu Vaccine in Preventing Influenza Infection in Healthy Volunteers and in Patients Who Have Undergone Stem Cell Transplant
Condition: Chronic Myeloproliferative Disorders; Leukemia; Lymphoma; Multiple Myeloma and Plasma Cell Neoplasm; Myelodysplastic Syndromes; Myelodysplastic/Myeloproliferative Neoplasms; Nonmalignant Neoplasm
MeSH terms: Lymphoma; Leukemia; Neoplasms; Multiple Myeloma; Neoplasms, Plasma Cell; Preleukemia; Plasmacytoma; Myelodysplastic Syndromes; Myeloproliferative Disorders; Myelodysplastic-Myeloproliferative Diseases; Syndrome
Study type: Observational

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.
    

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.
    

Intervention name(s): trivalent influenza vaccine; Immunoenzyme technique; Laboratory biomarker analysis
Intervention type(s): Biological; Other; Other
Intervention description(s): 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.
Observational model: Case-Control
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        Stem cell donors, Autologous and Allogeneic HCT patients, Normal volunteers
      
Keywords: 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