Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients
Completed
Conditions studied: Influenza
In brief
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.
Key facts
- Study ID
- NCT02623075
- Run by
- Northwestern University
- People needed
- 19
- Starts
- 2015-10-01
- Expected to finish
- 2023-12-01
- Last updated by the study team
- 2025-05-16
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Northwestern University Comprehensive Transplant Center — Chicago, Illinois, United States
Full record on ClinicalTrials.gov
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