Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02623075
Recruitment Status : Active, not recruiting
First Posted : December 7, 2015
Last Update Posted : April 12, 2019
Sponsor:
Information provided by (Responsible Party):
Joseph Leventhal, Northwestern University

Brief 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. 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.

Condition or disease Intervention/treatment Phase
Influenza Biological: Influenza vaccine Phase 1 Phase 2

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.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influenza Vaccine Responses as a Means of Assessing Immune Competence in Chimeric Kidney/Stem Cell Transplant Recipients
Study Start Date : October 2015
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : April 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Transplant recipients (Chimeric)
Adults who have received a kidney/stem cell transplant and have achieved chimerism will receive the IIV4 (influenza vaccine).
Biological: Influenza vaccine
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).
Other Name: Fluarix

Experimental: 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).
Biological: Influenza vaccine
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).
Other Name: Fluarix

Active Comparator: Controls
Healthy adults who meet inclusion and exclusion criteria will receive the IIV4 (influenza vaccine).
Biological: Influenza vaccine
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).
Other Name: Fluarix




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 89 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02623075


Locations
Layout table for location information
United States, Illinois
Northwestern University Comprehensive Transplant Center
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Layout table for investigator information
Principal Investigator: Joseph Leventhal, MD, PhD Northwestern University

Layout table for additonal information
Responsible Party: Joseph Leventhal, Professor of Surgery, Organ Transplantation, Northwestern University
ClinicalTrials.gov Identifier: NCT02623075     History of Changes
Other Study ID Numbers: STU00201741
First Posted: December 7, 2015    Key Record Dates
Last Update Posted: April 12, 2019
Last Verified: April 2019

Additional relevant MeSH terms:
Layout table for MeSH terms
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs