An observational study in Chronic Myeloproliferative Disorders, Leukemia and Lymphoma, sponsored by City of Hope Medical Center. Completed at 2 sites in United States. Open to participants aged 18 Years to 120 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2017-11-07.
Sponsored by City of Hope Medical Center · Observational
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.
OBJECTIVES:
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.
5,578 studies on the registry are indexed under Lymphoma; 825 are open to participants now.
This study's enrollment of 459 is above the median of 136 across 625 observational studies indexed under Lymphoma.
Browse Lymphoma studies →City of Hope Medical Center is the lead sponsor of 670 studies on the registry; 181 are open to participants now.
Of its 30 completed or terminated interventional studies of FDA-regulated products, 12 (40%) have results posted.
Counted across the registry records on this site, refreshed daily.
Stem cell donors, Autologous and Allogeneic HCT patients, Normal volunteers
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 or B serotypes specific for the 2009-2010 or 2010-2011 influenza season
Employee volunteer from the City of Hope
PATIENT CHARACTERISTICS:
No hepatitis B or C seropositivity
PRIOR CONCURRENT THERAPY:
Patients and normal volunteers who have received a flu vaccine
Biological: trivalent influenza vaccine · Other: Immunoenzyme technique · Other: Laboratory biomarker analysis
Patients and normal volunteers who have not received the flu vaccine
Other: Immunoenzyme technique · Other: Laboratory biomarker analysis
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.
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.
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.
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.
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.
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.
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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