Adult Stem Cell Hematopoetic TransplantPhase 1NCT01215734
Standard vs High-Dose Trivalent Inactivated Flu Vaccine in Adult Hematopoetic Stem Cell Transplant (HSCT) Recipients
A Phase 1 study testing High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) and Standard Dose Trivalent Inactivated Flu Vaccine in people with Adult Stem Cell Hematopoetic Transplant, run by Vanderbilt-Ingram Cancer Center at 1 site in United States.
Trial summary
Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adult Stem Cell Hematopoetic Transplant
- What is being tested?
- High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) and Standard Dose Trivalent Inactivated Flu Vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2010to Sep 2012
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Allogeneic hematopoietic stem cell transplant recipients who are >6 post-transplant
- greater than or equal to 18 years of age
- Available for duration of study
- If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses will be eligible.
Who cannot join
- History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein
- History of Guillain-Barre syndrome
- Evidence of hematologic malignancy or disease relapse post-transplant (mixed chimerisms and molecular evidence of disease is permitted)
- Non-allogeneic (e.g. autologous) hematopoietic SCT recipients
- History of receiving 2011 - 2012 influenza vaccine
- History of proven influenza disease after September 1, 2011.
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- Pregnant females
- Have any condition that would, in the opinion of the site investigator, place them at an unacceptable risk of injury or render them unable to meet the requirements of the protocol
- Have any condition that the investigator believes may interfere with successful completion of the study
- Platelet count less than 50,000 cells/μL
- History of known infection with HIV, Hepatitis B or Hepatitis C
- History of known latex hypersensitivity
Trial locations and contacts
1 site in 1 country.
United States1 site
Vanderbilt-Ingram Cancer Center, Clinical Trials Information Program
Nashville, Tennessee, 37232
About this study
Official title: Randomized Double-Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Stem Cell Hematopoetic Transplant Recipients
Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV.
- Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplant recipients.
Read more
Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine.
- Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell transplant recipients influenza virus antigens included in trivalent influenza vaccine after high dose or standard dose trivalent influenza vaccine.
- Conditions
- Adult Stem Cell Hematopoetic Transplant
- Being tested
- High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV), Standard Dose Trivalent Inactivated Flu Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)Biological
0.5 ml of HD-TIV on visit 1
Standard Dose Trivalent Inactivated Flu VaccineBiological
Twenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1.
| Study group | Role | What they receive |
|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | Active comparator | Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine Receives: Biological: High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) |
| Standard dose Trivalent Inactivated Flu Vaccine | Active comparator | Twenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine. Receives: Biological: Standard Dose Trivalent Inactivated Flu Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients
Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level.
Measured: Day of TIV to 7 days after TIV
Secondary outcomes (1)
Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses
Adult hematopoetic stem cell transplant recipients at least 6 months post-transplant receiving either HD or SD TIV who had blood drawn at pre-vaccination and at 28-42 days post-vaccination and who experienced a 4-fold rise in each of three post-vaccination influenza antibody titers, relative to their baseline titers. Trivalent vaccine is for the H1N1/H3N2/B influenzas. A 4-fold rise in type-specific antibody titer is considered adequate antibody response to the specific influenza virus
Measured: Before TIV and 28-42 days after TIV
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2010 (estimated)
- Study startOct 2010
- Primary completionApr 2012
- Study completionSep 2012
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 Adult Stem Cell Hematopoetic TransplantStudies of the same condition, open and under way.
- 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt-Ingram Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Natasha Halasa, MD, Vanderbilt-Ingram Cancer Center
- Investigators
- Natasha Halasa, M.D., M.P.H., Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01215734
- Sponsor's protocol ID
- VICC BMT 1057
- Other IDs
- 100980, 100980
- Status last verified
- Feb 2013
- First submitted
- 5 Oct 2010
- Last updated
- 8 Mar 2013
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Double-Blind, Comparison of Standard Dose Trivalent Inactivated Influenza Vaccine Versus High-Dose Trivalent Inactivated Influenza Vaccine in Adult Stem Cell Hematopoetic Transplant Recipients
- ClinicalTrials.gov ID
- NCT01215734
- Acronym / sponsor ID
- VICC BMT 1057
- Conditions
- Adult Stem Cell Hematopoetic Transplant
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Vanderbilt-Ingram Cancer CenterUniversity, hospital or other
- Study start
- Oct 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2012 (actual)
- First posted
- 6 Oct 2010 (estimated)
- Results
- Posted 8 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Hypothesis 1: The safety profile in adult allogeneic stem cell hematopoietic transplant (SCT) recipients after high dose (HD) trivalent inactivated influenza vaccine (TIV) will not be significantly different from adult stem cell transplant recipients receiving standard dose (SD) TIV.
- Specific Aim 1: To compare safety profile of high dose trivalent inactivated influenza vaccine to standard dose trivalent inactivated influenza vaccine in adult hematopoietic stem cell transplant recipients.
Hypothesis 2: Adult stem cell transplant recipients who received the higher dose trivalent influenza vaccine will have a greater frequency of (at least a 4-fold) rise in antibody titers to influenza antigens compared to those who receive standard dose trivalent influenza vaccine.
- Specific Aim 2: To compare humoral immune responses of adult hematopoietic stem cell transplant recipients influenza virus antigens included in trivalent influenza vaccine after high dose or standard dose trivalent influenza vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine | Active comparator | Biological: High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)Forty adult hematopoetic stem cell transplant recipients at least 6 months post transplant will receive high dose trivalent influenza vaccine |
| Standard dose Trivalent Inactivated Flu Vaccine | Active comparator | Biological: Standard Dose Trivalent Inactivated Flu VaccineTwenty Adult stem cell transplant recipients at least 6 months post transplant will receive standard dose trivalent influenza vaccine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Allogeneic hematopoietic stem cell transplant recipients who are >6 post-transplant
- greater than or equal to 18 years of age
- Available for duration of study
- If patients are on immunosuppressive therapy for treatment of graft versus host disease (GVHD): only those on stable doses for at least 4 weeks or on tapering doses will be eligible.
Key exclusion criteria (12 listed)
- History of hypersensitivity to previous influenza vaccination or hypersensitivity to eggs/egg protein
- History of Guillain-Barre syndrome
- Evidence of hematologic malignancy or disease relapse post-transplant (mixed chimerisms and molecular evidence of disease is permitted)
- Non-allogeneic (e.g. autologous) hematopoietic SCT recipients
- History of receiving 2011 - 2012 influenza vaccine
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 |
|---|---|---|
| High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV)0.5 ml of HD-TIV on visit 1 | Biological | High-Dose Trivalent Inactivated Influenza Vaccine |
| Standard Dose Trivalent Inactivated Flu VaccineTwenty adult hematopoetic stem cell transplant recipients will receive 0.5 ml standard dose trivalent influenza vaccine on visit 1. | Biological | Standard dose Trivalent Inactivated Flu Vaccine |
Primary outcome
Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients
Time frame: Day of TIV to 7 days after TIV
Patients were questioned about the following adverse events related to TIV: Local: pain, tenderness, swelling/induration, or erythema at injection site. Systemic: fatigue/malaise, headache, nausea, vomiting, body ache not at injection site, fever >= 100.4 degrees Fahrenheit, or change in activity level.
1 secondary outcome
Patients Receiving HD or SD TIV With a 4-fold Rise in Hemagglutination Inhibition (HAI) Titers Relative to Baseline for Each of 3 Influenza Viruses
Time frame: Before TIV and 28-42 days after TIV
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Vanderbilt-Ingram Cancer Center, Find a Clinical TrialLink 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.
Natasha Halasa, M.D., M.P.H. principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing High-Dose Trivalent Inactivated Influenza Vaccine (HD-TIV) and Standard Dose Trivalent Inactivated Flu Vaccine in people with Adult Stem Cell Hematopoetic Transplant, run by Vanderbilt-Ingram Cancer Center 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 4 inclusion and 12 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: finished, as of the sponsor's last update on 8 Mar 2013. 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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2013). 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?
Patients Experiencing at Least 1 Solicited Local and/or Systemic Adverse Event After High Dose (HD) Trivalent Influenza Vaccine (TIV) or Standard Dose (SD) Trivalent Influenza Vaccine in Adult Hematopoetic Stem Cell Transplant (SCT) Recipients (time frame: Day of TIV to 7 days after TIV). 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 8 Mar 2013.