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

NCT02623075 | Completed

• 1 other identifier: STU00201741
• Study Type: observational
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Study Arms (3)

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

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

Controls

Healthy adults who meet inclusion and exclusion criteria will receive the IIV4 (influenza vaccine).

Biological: Influenza vaccine

Interventions

Influenza vaccine BIOLOGICAL

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).

Also known as: Fluarix

Controls; Transplant recipients (Chimeric); Transplant recipients (IS)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

kidney/stem cell transplant recipients

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.

Sponsors & Collaborators

• Northwestern University: lead

Study Sites (1)

Northwestern University Comprehensive Transplant Center

Chicago, Illinois, 60611, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Whole blood

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines; fluarix

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Study Officials

• Joseph Leventhal, MD, PhD

  Northwestern University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Surgery, Organ Transplantation

Study Record Dates

• First Submitted: November 19, 2015
• First Posted: December 7, 2015
• Study Start: October 1, 2015
• Primary Completion: December 5, 2016
• Study Completion: December 1, 2023
• Last Updated: May 16, 2025

Record last verified: 2025-05

Locations

US (1)