NCT00964821

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
459

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
2.6 years until next milestone

First Submitted

Initial submission to the registry

August 22, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 25, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
Last Updated

November 7, 2017

Status Verified

November 1, 2017

Enrollment Period

6.3 years

First QC Date

August 22, 2009

Last Update Submit

November 3, 2017

Conditions

Chronic Myeloproliferative DisordersLeukemiaLymphomaMultiple Myeloma and Plasma Cell NeoplasmMyelodysplastic SyndromesMyelodysplastic/Myeloproliferative NeoplasmsNonmalignant Neoplasm

Keywords

stage III adult Burkitt lymphomastage III adult diffuse large cell lymphomastage III adult diffuse mixed cell lymphomastage III adult diffuse small cleaved cell lymphomastage III adult Hodgkin lymphomastage III adult immunoblastic large cell lymphomastage III adult lymphoblastic lymphomastage III grade 1 follicular lymphomastage III grade 2 follicular lymphomastage III grade 3 follicular lymphomastage III mantle cell lymphomastage III marginal zone lymphomastage III small lymphocytic lymphomastage IV adult Burkitt lymphomastage IV adult diffuse large cell lymphomastage IV adult diffuse mixed cell lymphomastage IV adult diffuse small cleaved cell lymphomastage IV adult Hodgkin lymphomastage IV adult immunoblastic large cell lymphomastage IV adult lymphoblastic lymphomastage IV grade 1 follicular lymphomastage IV grade 2 follicular lymphomastage IV grade 3 follicular lymphomastage IV mantle cell lymphomastage IV marginal zone lymphomastage IV small lymphocytic lymphomarecurrent adult Burkitt lymphomarecurrent adult diffuse large cell lymphomarecurrent adult diffuse mixed cell lymphomarecurrent adult diffuse small cleaved cell lymphomarecurrent adult Hodgkin lymphomarecurrent adult immunoblastic large cell lymphomarecurrent adult lymphoblastic lymphomarecurrent childhood large cell lymphomarecurrent cutaneous T-cell non-Hodgkin lymphomarecurrent grade 1 follicular lymphomarecurrent grade 2 follicular lymphomarecurrent grade 3 follicular lymphomarecurrent mantle cell lymphomarecurrent marginal zone lymphomarecurrent small lymphocytic lymphomarecurrent mycosis fungoides/Sezary syndromeextranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissuenodal marginal zone B-cell lymphomasplenic marginal zone lymphomanoncontiguous stage II adult Burkitt lymphomanoncontiguous stage II adult diffuse large cell lymphomanoncontiguous stage II adult diffuse mixed cell lymphomanoncontiguous stage II adult diffuse small cleaved cell lymphomanoncontiguous stage II adult immunoblastic large cell lymphomanoncontiguous stage II adult lymphoblastic lymphomanoncontiguous stage II grade 1 follicular lymphomanoncontiguous stage II grade 2 follicular lymphomanoncontiguous stage II grade 3 follicular lymphomanoncontiguous stage II mantle cell lymphomanoncontiguous stage II marginal zone lymphomanoncontiguous stage II small lymphocytic lymphomaaccelerated phase chronic myelogenous leukemiaadult acute lymphoblastic leukemia in remissionadult acute myeloid leukemia in remissionadult acute myeloid leukemia with 11q23 (MLL) abnormalitiesadult 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 negativeblastic phase chronic myelogenous leukemiachronic myelomonocytic leukemiachronic phase chronic myelogenous leukemiarecurrent adult acute lymphoblastic leukemiarecurrent adult acute myeloid leukemiarefractory chronic lymphocytic leukemiarefractory hairy cell leukemiarelapsing chronic myelogenous leukemiasecondary acute myeloid leukemiastage III chronic lymphocytic leukemiastage IV chronic lymphocytic leukemiachronic eosinophilic leukemiaprimary myelofibrosischronic neutrophilic leukemiade novo myelodysplastic syndromesmyelodysplastic/myeloproliferative neoplasm, unclassifiablepreviously treated myelodysplastic syndromessecondary myelodysplastic syndromesstage I multiple myelomastage II multiple myelomastage III multiple myelomarefractory multiple myelomaaplastic anemia

Outcome Measures

Primary Outcomes (1)

  • Humoral and cellular memory immune responses in patients and healthy volunteers

    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.

Secondary Outcomes (4)

  • Incidence rate of influenza or respiratory incidence in patients after vaccination

    1 year after vaccination or two years after transplant if not vaccinated.

  • Impact of graft-vs-host disease on immune reconstitution and vaccine response

    1 year after vaccination or two years after transplant if not vaccinated.

  • Impact of age ≥ 60 years on immune reconstitution of after vaccination

    1 year after vaccination or two years after transplant if not vaccinated.

  • Differences between antibody and cytokine (CD8 and CD4) response

    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.

Study Arms (2)

Flu vaccine

Patients and normal volunteers who have received a flu vaccine

Biological: trivalent influenza vaccineOther: Immunoenzyme techniqueOther: Laboratory biomarker analysis

Non-vaccine

Patients and normal volunteers who have not received the flu vaccine

Other: Immunoenzyme techniqueOther: Laboratory biomarker analysis

Interventions

trivalent influenza vaccineBIOLOGICAL

Patients or normal volunteers who will be vaccinated against the flu.

Flu vaccine
Immunoenzyme techniqueOTHER

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.

Flu vaccineNon-vaccine
Laboratory biomarker analysisOTHER

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.

Flu vaccineNon-vaccine

Eligibility Criteria

Age18 Years - 120 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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 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

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (2)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

City of Hope Medical Group

Pasadena, California, 91105, United States

Location

MeSH Terms

Conditions

Myeloproliferative DisordersLeukemiaLymphomaMultiple MyelomaNeoplasms, Plasma CellMyelodysplastic SyndromesMyelodysplastic-Myeloproliferative DiseasesNeoplasmsBurkitt LymphomaLymphoma, Large B-Cell, DiffuseLymphoma, Non-HodgkinHodgkin DiseaseLymphoma, Large-Cell, ImmunoblasticPrecursor Cell Lymphoblastic Leukemia-LymphomaLymphoma, FollicularLymphoma, Mantle-CellLymphoma, B-Cell, Marginal ZoneLeukemia, Lymphocytic, Chronic, B-CellDendritic Cell Sarcoma, InterdigitatingLymphoma, T-Cell, CutaneousMycosis FungoidesSezary SyndromeLeukemia, Myeloid, Accelerated PhaseCongenital AbnormalitiesLeukemia, Myeloid, Chronic, Atypical, BCR-ABL NegativeBlast CrisisLeukemia, Myelomonocytic, ChronicLeukemia, Myeloid, Chronic-PhaseLeukemia, Myeloid, AcuteLeukemia, Hairy CellPdgfra-Associated Chronic Eosinophilic LeukemiaPrimary MyelofibrosisLeukemia, Neutrophilic, ChronicAnemia, Aplastic

Interventions

Influenza VaccinesImmunoenzyme Techniques

Condition Hierarchy (Ancestors)

Bone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesNeoplasms by Histologic TypeLymphoproliferative DisordersLymphatic DiseasesImmunoproliferative DisordersImmune System DiseasesHemostatic DisordersVascular DiseasesCardiovascular DiseasesParaproteinemiasBlood Protein DisordersHemorrhagic DisordersEpstein-Barr Virus InfectionsHerpesviridae InfectionsDNA Virus InfectionsVirus DiseasesInfectionsTumor Virus InfectionsLymphoma, B-CellLeukemia, LymphoidLeukemia, B-CellChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsHistiocytic Disorders, MalignantHistiocytosisLymphoma, T-CellLeukemia, Myelogenous, Chronic, BCR-ABL PositiveLeukemia, MyeloidCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesCell Transformation, NeoplasticCarcinogenesisNeoplastic ProcessesAnemiaBone Marrow Failure Disorders

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex MixturesImmunoassayImmunologic TechniquesInvestigative TechniquesImmunohistochemistryMolecular Probe Techniques

Study Officials

  • Don Diamond, PhD

    City of Hope Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 22, 2009

First Posted

August 25, 2009

Study Start

January 1, 2007

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 7, 2017

Record last verified: 2017-11

Locations

US(2)