Influenza Vaccine in Lung Transplant Patients

Study Overview
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Brief Summary
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This 5-year study was designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.

Detailed Description
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[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data] Although pre-transplant immunization is routinely recommended, this recommendation is based on little data. The primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant. This prospective cohort study is to include immunization events performed over five years to measure H1N1, H3N2, and B antibody responses to the influenza vaccine in pre- and post-lung transplant patients. The pre-transplant patients will move to the post-transplant group as the study progressed. Similarly, participants are allowed to move to the next time-since-transplant group as time elapsed. Serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season. Geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.

Official Title
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Antibody Responses to Influenza Vaccine in Pre- and Post-lung Transplant Patients

Conditions
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Influenza

Intervention / Treatment
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* Drug: Influenza vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Receiving care pre- or post-lung transplant at University of Wisconsin Hospital Healthy adult Exclusion Criteria: Allergy to eggs Moderate to severe febrile illness Active treatment for acute rejection Received season's influenza vaccine prior to enrollment

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Pre-transplant Vaccine<br>Cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually. | Drug: Influenza vaccine<br>* influenza vaccine 0.5 ml intramuscularly each season<br>|
| 0-6 Months Post-transplant Vaccine<br>Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 0-6 months post transplant. | Drug: Influenza vaccine<br>* influenza vaccine 0.5 ml intramuscularly each season<br>|
| 13-60 months Post-transplant Vaccine<br>Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 13-60 months post transplant. | Drug: Influenza vaccine<br>* influenza vaccine 0.5 ml intramuscularly each season<br>|
| Greater than 110 months Post-transplant Vaccine<br>Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine greater than 110 months post transplant. | Drug: Influenza vaccine<br>* influenza vaccine 0.5 ml intramuscularly each season<br>|
| Healthy Controls<br>Healthy controls to measure normal immune response to the influenza vaccine | Drug: Influenza vaccine<br>* influenza vaccine 0.5 ml intramuscularly each season<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antibody response to influenza vaccine |  | Each season | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| T cell response to influenza vaccine antigens |  | Each season for the first two seasons | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pre or post-lung transplant, Healthy