Chronic Myeloproliferative DisordersNCT00964821
Flu Vaccine in Preventing Influenza Infection in Healthy Volunteers and in Patients Who Have Undergone Stem Cell Transplant
An observational study of Chronic Myeloproliferative Disorders and Leukemia, run by City of Hope Medical Center at 2 sites in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 120 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma
- What is being tested?
- trivalent influenza vaccine, Immunoenzyme technique and Laboratory biomarker analysis
- Type of treatment
- Vaccines
- How many people
- 459 participants
- Where
- 2 sitesUnited States
- Study dates
- Jan 2007to May 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 120 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
City of Hope Comprehensive Cancer Center
Duarte, California, 91010-3000
City of Hope Medical Group
Pasadena, California, 91105
About this study
Official title: Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation
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.
Read the 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.
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- Being tested
- trivalent influenza vaccine, Immunoenzyme technique, Laboratory biomarker analysis
- 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
- Medical subject headings
- Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma, Neoplasms, Plasma Cell, Myelodysplastic Syndromes, Myelodysplastic-Myeloproliferative Diseases, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
trivalent influenza vaccineBiological
Patients or normal volunteers who will be vaccinated against the flu.
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.
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.
| Study group | Role | What they receive |
|---|---|---|
| Flu vaccine | Patients and normal volunteers who have received a flu vaccine Receives: Biological: trivalent influenza vaccine; Other: Immunoenzyme technique; Other: Laboratory biomarker analysis | |
| Non-vaccine | Patients and normal volunteers who have not received the flu vaccine Receives: Other: Immunoenzyme technique; Other: Laboratory biomarker analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Humoral and cellular memory immune responses in patients and healthy volunteers
Measured: 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
Measured: 1 year after vaccination or two years after transplant if not vaccinated.
Impact of graft-vs-host disease on immune reconstitution and vaccine response
Measured: 1 year after vaccination or two years after transplant if not vaccinated.
Impact of age ≥ 60 years on immune reconstitution of after vaccination
Measured: 1 year after vaccination or two years after transplant if not vaccinated.
Differences between antibody and cytokine (CD8 and CD4) response
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2009 (estimated)
- Study startJan 2007
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Myeloproliferative DisordersStudies of the same condition, open and under way.
- More trials run by City of Hope Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 459 participants (actual)
Sponsor and investigators
- Lead sponsor
- City of Hope Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Don Diamond, PhD, Principal investigator, City of Hope Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00964821
- Sponsor's protocol ID
- 06157
- Other IDs
- P30CA033572, CHNMC-06157, CDR0000652790
- Status last verified
- Nov 2017
- First submitted
- 22 Aug 2009
- Last updated
- 7 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Specific Humoral and Cellular Immunity After Vaccination in Recipients of Allogeneic and Autologous Hematopoietic Stem Cell Transplantation
- ClinicalTrials.gov ID
- NCT00964821
- Acronym / sponsor ID
- 06157
- Conditions
- Chronic Myeloproliferative Disorders, Leukemia, Lymphoma, Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Myelodysplastic/Myeloproliferative Neoplasms
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 459 participants (actual)
- Lead sponsor
- City of Hope Medical CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- Jan 2007
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 25 Aug 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Flu vaccine | – | Biological: trivalent influenza vaccine, Other: Immunoenzyme technique, Other: Laboratory biomarker analysisPatients and normal volunteers who have received a flu vaccine |
| Non-vaccine | – | Other: Immunoenzyme technique, Other: Laboratory biomarker analysisPatients and normal volunteers who have not received the flu vaccine |
Who may qualify
- Ages
- 18 to 120 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Stem cell donors, Autologous and Allogeneic HCT patients, Normal volunteers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| trivalent influenza vaccinePatients or normal volunteers who will be vaccinated against the flu. | Biological | Flu vaccine |
| Immunoenzyme techniqueThis 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 | Flu vaccine, Non-vaccine |
| Laboratory biomarker analysisThis 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. | Other | Flu vaccine, Non-vaccine |
Primary outcome
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.
4 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Don Diamond, PhD principal investigator
City of Hope Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Myeloproliferative Disorders and Leukemia, run by City of Hope Medical Center at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2017.