Flu Vaccine in Preventing Influenza Infection in Healthy Volunteers and in Patients Who Have Undergone Stem Cell Transplant
This study has been completed.
Sponsor:
City of Hope Medical Center
Collaborator:
Information provided by (Responsible Party):
City of Hope Medical Center
ClinicalTrials.gov Identifier:
NCT00964821
First received: August 22, 2009
Last updated: May 10, 2013
Last verified: May 2013
- Full Text View
- Tabular View
- No Study Results Posted
- Disclaimer
- How to Read a Study Record
Purpose
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.
| Condition | Intervention |
|---|---|
|
Chronic Myeloproliferative Disorders Leukemia Lymphoma Multiple Myeloma and Plasma Cell Neoplasm Myelodysplastic Syndromes Myelodysplastic/Myeloproliferative Neoplasms Nonmalignant Neoplasm |
Biological: trivalent influenza vaccine Other: immunoenzyme technique Other: laboratory biomarker analysis |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation |
Resource links provided by NLM:
Genetics Home Reference related topics:
familial acute myeloid leukemia with mutated CEBPA
mycosis fungoides
primary myelofibrosis
Sézary syndrome
MedlinePlus related topics:
Acute Myeloid Leukemia
Cancer
Chronic Lymphocytic Leukemia
Chronic Myeloid Leukemia
Flu
Hodgkin Disease
Leukemia
Lymphoma
Multiple Myeloma
Myelodysplastic Syndromes
Drug Information available for:
Influenza Vaccines
U.S. FDA Resources
Further study details as provided by City of Hope Medical Center:
Primary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
- 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. ] [ Designated as safety issue: No ]
| Enrollment: | 459 |
| Study Start Date: | January 2007 |
| Primary Completion Date: | May 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Active Comparator: Flu vaccine
Patients and normal volunteers who have received a flu vaccine
|
Biological: trivalent influenza vaccine
Patients or normal volunteers who will be vaccinated against the flu.
Other: 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.
Other: 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.
|
|
Active Comparator: Non-vaccine
Patients and normal volunteers who have not received the flu vaccine
|
Other: 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.
Other: 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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00964821
Locations
| United States, California | |
| City of Hope Comprehensive Cancer Center | |
| Duarte, California, United States, 91010-3000 | |
| City of Hope Medical Group | |
| Pasadena, California, United States, 91105 | |
Sponsors and Collaborators
City of Hope Medical Center
Investigators
| Principal Investigator: | Don Diamond, PhD | City of Hope Medical Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | City of Hope Medical Center |
| ClinicalTrials.gov Identifier: | NCT00964821 History of Changes |
| Other Study ID Numbers: | 06157, P30CA033572, CHNMC-06157, CDR0000652790 |
| Study First Received: | August 22, 2009 |
| Last Updated: | May 10, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by City of Hope Medical Center:
|
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 |
Additional relevant MeSH terms:
|
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 Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Neoplasms by Histologic Type Lymphoproliferative Disorders Lymphatic Diseases Immunoproliferative Disorders Immune System Diseases Hemostatic Disorders Vascular Diseases Cardiovascular Diseases Paraproteinemias Blood Protein Disorders Hematologic Diseases Hemorrhagic Disorders |
ClinicalTrials.gov processed this record on May 22, 2013