InfluenzaNCT02623075
Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients
An observational study of Influenza, run by Northwestern University at 1 site in United States.
Trial summary
Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the effects of immunosuppression which is necessary to prevent rejection of the transplanted organ. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines
- How many people
- 19 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Dec 2023
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: kidney/stem cell transplant recipients
Who may be able to join
- Adults who have received either a combined kidney/stem cell transplant and have achieved chimerism or post-transplant recipients who are maintained on standard immunosuppressive therapy. Additionally, healthy controls of either gender ≥ 18 years of age will also be recruited.
- Subjects must be willing and able to receive the IIV4 and provide blood samples at research visits.
- Subjects must be willing and able to read, understand, and be capable of giving informed consent for prospective enrollment.
Who cannot join
- Subjects less than 18 years of age.
- Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy or inability to receive the IIV4.
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern University Comprehensive Transplant Center
Chicago, Illinois, 60611
About this study
Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the effects of immunosuppression which is necessary to prevent rejection of the transplanted organ. However, transplant patients are less likely to produce antibodies when vaccinated and when they do, the peak and duration of antibody responses are reduced compared to healthy controls. There are considerable differences in the magnitude of these responses, reflecting variability in individual responses to the influenza vaccine and to the immunosuppression regimen. The investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression will have post vaccine immune responses that are comparable to age and gender matched healthy controls.
Read the detailed description
Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the effects of immunosuppression which is necessary to prevent rejection of the transplanted organ. Annual influenza vaccination is the best way to prevent influenza infection and current CDC, AST Infectious Diseases Community of Practice and American Society for Blood and Marrow Transplantation guidelines recommend annual influenza vaccination to all transplant recipients. However, transplant patients are less likely to produce antibodies when vaccinated and when they do, the peak and duration of antibody responses are reduced compared to healthy controls. There are considerable differences in the magnitude of these responses, reflecting variability in individual responses to the influenza vaccine and to the immunosuppression regimen.
Over the past several years, the investigators have conducted a Phase 2 clinical trial of combined kidney and stem cell transplantation that has been successful in achieving transplantation tolerance in a significant number of recipients. A central tenant for transplantation tolerance is a selective loss of immune reactivity to the allograft while preserving immune responses to all other antigens. The investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression will have post vaccine immune responses that are comparable to age and gender matched healthy controls. The proposed studies aim to assess the immune competence in these fully chimeric tolerant recipients, by quantifying their T and B cell responses to the 2015-2016 inactivated influenza vaccine, quadrivalent (IIV4), standard dose and by testing whether the responding T and B cells arise from memory cells of recipient origin.
These studies will allow the investigators to quantify the influenza -specific cellular, humoral, and molecular responses to IIV4 in tolerant vs. matched controls. On days 0 and 30 days post -IIV4, the flu-specific B cell and neutralizing antibody responses, and the flu-specific IFN-gamma T cell response will be quantified. Additionally, the investigators will perform genome-wide gene expression profiling on isolated PBMC on days 0 and 30 post-IIV4 to characterize the blood response at the transcriptome level.
- Conditions
- Influenza
- Being tested
- Influenza vaccine
- Medical subject headings
- 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 Fluarix
Blood samples will be collected at research study visits at 0 and 30 days (+/- 2 days) post-IIV4 (influenza vaccine). Collection will be as follows: 45-50 ml blood at each visit (not to exceed more than three visits over a two month period).
| Study group | Role | What they receive |
|---|---|---|
| Transplant recipients (Chimeric) | Adults who have received a kidney/stem cell transplant and have achieved chimerism will receive the IIV4 (influenza vaccine). Receives: Biological: Influenza vaccine | |
| Transplant recipients (IS) | Adults who have received a kidney/stem cell transplant and are currently maintained on standard immunosuppressive therapy will receive the IIV4 (influenza vaccine). Receives: Biological: Influenza vaccine | |
| Controls | Healthy adults who meet inclusion and exclusion criteria will receive the IIV4 (influenza vaccine). Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of Immune Response in Transplant Recipient Blood Assays
To quantify the response to inactivated influenza vaccine, quadrivalent (IIV4), standard dose in up to 15 tolerance (chimeric) recipients compared to 15 matched, healthy controls and 15 matched, kidney transplant recipients on standard immunosuppression
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2015 (estimated)
- Study startOct 2015
- Primary completion5 Dec 2016
- Study completionDec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe 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
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Leventhal, Northwestern University
- Investigators
- Joseph Leventhal, MD, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02623075
- Sponsor's protocol ID
- STU00201741
- Status last verified
- May 2025
- First submitted
- 19 Nov 2015
- Last updated
- 16 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients
- ClinicalTrials.gov ID
- NCT02623075
- Acronym / sponsor ID
- STU00201741
- Conditions
- Influenza
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- Oct 2015 (actual)
- Primary completion
- 5 Dec 2016 (actual)
- Study completion
- Dec 2023 (actual)
- First posted
- 7 Dec 2015 (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.
Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the effects of immunosuppression which is necessary to prevent rejection of the transplanted organ. However, transplant patients are less likely to produce antibodies when vaccinated and when they do, the peak and duration of antibody responses are reduced compared to healthy controls. There are considerable differences in the magnitude of these responses, reflecting variability in individual responses to the influenza vaccine and to the immunosuppression regimen. The investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression will have post vaccine immune responses that are comparable to age and gender matched healthy controls.
Detailed description
Influenza infection in solid organ transplant recipients is associated with increased morbidity and mortality compared to non-transplanted controls, due in part to the effects of immunosuppression which is necessary to prevent rejection of the transplanted organ. Annual influenza vaccination is the best way to prevent influenza infection and current CDC, AST Infectious Diseases Community of Practice and American Society for Blood and Marrow Transplantation guidelines recommend annual influenza vaccination to all transplant recipients. However, transplant patients are less likely to produce antibodies when vaccinated and when they do, the peak and duration of antibody responses are reduced compared to healthy controls. There are considerable differences in the magnitude of these responses, reflecting variability in individual responses to the influenza vaccine and to the immunosuppression regimen.
Over the past several years, the investigators have conducted a Phase 2 clinical trial of combined kidney and stem cell transplantation that has been successful in achieving transplantation tolerance in a significant number of recipients. A central tenant for transplantation tolerance is a selective loss of immune reactivity to the allograft while preserving immune responses to all other antigens. The investigators hypothesize that chimeric kidney transplant recipients off of immunosuppression will have post vaccine immune responses that are comparable to age and gender matched healthy controls. The proposed studies aim to assess the immune competence in these fully chimeric tolerant recipients, by quantifying their T and B cell responses to the 2015-2016 inactivated influenza vaccine, quadrivalent (IIV4), standard dose and by testing whether the responding T and B cells arise from memory cells of recipient origin.
These studies will allow the investigators to quantify the influenza -specific cellular, humoral, and molecular responses to IIV4 in tolerant vs. matched controls. On days 0 and 30 days post -IIV4, the flu-specific B cell and neutralizing antibody responses, and the flu-specific IFN-gamma T cell response will be quantified. Additionally, the investigators will perform genome-wide gene expression profiling on isolated PBMC on days 0 and 30 post-IIV4 to characterize the blood response at the transcriptome level.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Transplant recipients (Chimeric) | – | Biological: Influenza vaccineAdults who have received a kidney/stem cell transplant and have achieved chimerism will receive the IIV4 (influenza vaccine). |
| Transplant recipients (IS) | – | Biological: Influenza vaccineAdults who have received a kidney/stem cell transplant and are currently maintained on standard immunosuppressive therapy will receive the IIV4 (influenza vaccine). |
| Controls | – | Biological: Influenza vaccineHealthy adults who meet inclusion and exclusion criteria will receive the IIV4 (influenza vaccine). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- kidney/stem cell transplant recipients
Key inclusion criteria (3 listed)
- Adults who have received either a combined kidney/stem cell transplant and have achieved chimerism or post-transplant recipients who are maintained on standard immunosuppressive therapy. Additionally, healthy controls of either gender ≥ 18 years of age will also be recruited.
- Subjects must be willing and able to receive the IIV4 and provide blood samples at research visits.
- Subjects must be willing and able to read, understand, and be capable of giving informed consent for prospective enrollment.
Key exclusion criteria (2 listed)
- Subjects less than 18 years of age.
- Any condition that, in the opinion of the attending physician, would place the patient at undue risk by participating. Specific conditions include but are not limited to anemia prohibitive of phlebotomy, coagulopathy or inability to receive the IIV4.
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: FluarixBlood samples will be collected at research study visits at 0 and 30 days (+/- 2 days) post-IIV4 (influenza vaccine). Collection will be as follows: 45-50 ml blood at each visit (not to exceed more than three visits over a two month period). | Biological | Controls, Transplant recipients (Chimeric), Transplant recipients (IS) |
Primary outcome
Analysis of Immune Response in Transplant Recipient Blood Assays
Time frame: 1 year
To quantify the response to inactivated influenza vaccine, quadrivalent (IIV4), standard dose in up to 15 tolerance (chimeric) recipients compared to 15 matched, healthy controls and 15 matched, kidney transplant recipients on standard immunosuppression
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 16 May 2025.
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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.
Joseph Leventhal, MD, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza, run by Northwestern University 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 3 inclusion and 2 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 16 May 2025. 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?
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?
Analysis of Immune Response in Transplant Recipient Blood Assays (time frame: 1 year). 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 16 May 2025.