Hematopoietic Stem Cell TransplantNCT01215981
Influenza Vaccine Post Allogeneic Transplant
A study testing Influenza vaccine in people with Hematopoietic Stem Cell Transplant and Hematologic Malignancy, run by Masonic Cancer Center, University of Minnesota at 1 site in United States.
Trial summary
Study Design: This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. Read more about this study
- Who is it for?
- Ages 6 months and olderHealthy volunteers can take part
- Conditions the study is for
- Hematopoietic Stem Cell Transplant, Hematologic Malignancy
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 68 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2010to Jun 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 6 months and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Patient Population
- HSCT recipients who are greater than 60 days post transplant.
- Age 6 months and older who are greater than 60 days post post allogeneic hematopoietic cell transplant
- Show neutrophil recovery, platelet count > 50,000/mm3 (may be transfused), no known disease relapse
- No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
- No flu vaccine in previous 4 months, no Campath in previous 6 months, no intravenous immune globulin (IVIG) in previous 3 months
Show all 10Show fewer
- Controls:
- Age 18 to 50 years
- No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
- No flu vaccine in previous 4 months
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
United States1 site
Masonic Cancer Center, University of Minnesota
Minneapolis, Minnesota, 55455
About this study
Official title: MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?
Study Design:
This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.
- Being tested
- Influenza vaccine
- Keywords
- influenza vaccine
- Medical subject headings
- Hematologic Neoplasms, Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
Also called H1N1, H3N2, Influenza A vaccine, Influenza B vaccine
One dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
Influenza vaccineBiological
Also called Influenza A, H1N1, N3N2, Influenza B
Two doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B
| Study group | Role | What they receive |
|---|---|---|
| Participants Receiving 1 Dose of Vaccine | Active comparator | Control group participants (healthy volunteers):
* Age 18 to 50 years
* No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome
* No flu vaccine in previous 4 months
and/or HSCT recipients who are greater than 60 days post transplant. Receives: Biological: Influenza vaccine |
| Participants Receiving 2 Doses of Vaccine | Active comparator | Hematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant. Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Subjects With T-Cell Based Immune Response to Vaccine
The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.
Measured: 8 Weeks After Vaccination
Secondary outcomes (1)
Number of Subjects With H3 Based Immune Response to Vaccine
The secondary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific H3 immune responses (IFN-y Elispot). Response is defined as 4 fold increase in H3N1. Response is listed as a number of subjects (evaluable) that successfully responded.
Measured: 8 Weeks After Vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2010 (estimated)
- Study startSep 2010
- Primary completionJun 2011
- Study completionJun 2011
Why it stopped: Lack of patients and no longer influenza vaccine season.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hematopoietic Stem Cell TransplantStudies of the same condition, open and under way.
- More trials run by Masonic Cancer Center, University of MinnesotaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 68 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masonic Cancer Center, University of Minnesota
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Verneris, M.D., Principal investigator, Masonic Cancer Center, University of Minnesota
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215981
- Sponsor's protocol ID
- 2010NTLS050
- Other IDs
- MT2010-08R, 1007M86296
- Status last verified
- Dec 2017
- First submitted
- 5 Oct 2010
- Last updated
- 28 Dec 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- MT2010-08R Influenza Vaccine Specific Immune Responses After Allogeneic Hematopoietic Cell Transplantation: Are One or Two Vaccine Doses Needed?
- ClinicalTrials.gov ID
- NCT01215981
- Acronym / sponsor ID
- 2010NTLS050
- Keywords
- influenza vaccine
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Lack of patients and no longer influenza vaccine season.
- Enrolment
- 68 participants (actual)
- Lead sponsor
- Masonic Cancer Center, University of MinnesotaUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 7 Oct 2010 (estimated)
- Results
- Posted 16 Aug 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Study Design:
This is a randomized, single center study to evaluate immune responses to the seasonal influenza vaccine in allogeneic hematopoietic stem cell transplant (HSCT) recipients who receive one vaccine or two vaccine doses one month apart. In addition, a cohort of healthy adult volunteers will be recruited as controls to confirm immune response to a single influenza vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants Receiving 1 Dose of Vaccine | Active comparator | Biological: Influenza vaccineControl group participants (healthy volunteers): * Age 18 to 50 years * No history of previous allergic reaction to influenza vaccine, known egg allergy or Guillan-Barre Syndrome * No flu vaccine in previous 4 months and/or HSCT recipients who are greater than 60 days post transplant. |
| Participants Receiving 2 Doses of Vaccine | Active comparator | Biological: Influenza vaccineHematopoietic stem cell transplant (HSCT) recipients who are greater than 60 days post transplant. |
Who may qualify
- Ages
- 6 months and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patient Population
- Controls:
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Influenza vaccineAlso: H1N1, H3N2, Influenza A vaccine, Influenza B vaccineOne dose of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B | Biological | Participants Receiving 1 Dose of Vaccine |
| Influenza vaccineAlso: Influenza A, H1N1, N3N2, Influenza BTwo doses of inactivated hemagglutinins of influenza A (H1N1, H3N2) and influenza B | Biological | Participants Receiving 2 Doses of Vaccine |
Primary outcome
Number of Subjects With T-Cell Based Immune Response to Vaccine
Time frame: 8 Weeks After Vaccination
The primary endpoint of this study is to measure the response to the vaccine with laboratory studies including viral specific T cell immune responses. Response is defined as 4 times above the background after a filter plate was developed. Response is listed as a number of subjects (evaluable) that successfully responded.
1 secondary outcome
Number of Subjects With H3 Based Immune Response to Vaccine
Time frame: 8 Weeks After Vaccination
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Dec 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Randomized Trial of One versus Two Doses of Influenza Vaccine after Allogeneic TransplantationLink provided by the sponsor.
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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.
Michael Verneris, M.D. principal investigator
Masonic Cancer Center, University of Minnesota
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Influenza vaccine in people with Hematopoietic Stem Cell Transplant and Hematologic Malignancy, run by Masonic Cancer Center, University of Minnesota at 1 site 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?
The sponsor lists 10 inclusion and 0 exclusion criteria. 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: stopped early, as of the sponsor's last update on 28 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Yes. Results are posted in the registry (first posted 16 Aug 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Subjects With T-Cell Based Immune Response to Vaccine (time frame: 8 Weeks After Vaccination). 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 28 Dec 2017.