Influenza Vaccine in Lung Transplant Patients

Completed

• Conditions: Influenza
• Interventions: Drug: Influenza vaccine

• Registration Number: NCT00205270
• Lead Sponsor: University of Wisconsin, Madison

Brief Summary

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

\[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data\]

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.

Study Timeline

• Study Start: 2004-12
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-20
• Primary Completion: 2009-07
• Study Completion: 2009-07
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pre-transplant Vaccine	Influenza vaccine	Cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.
0-6 Months Post-transplant Vaccine	Influenza vaccine	Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 0-6 months post transplant.
13-60 months Post-transplant Vaccine	Influenza vaccine	Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 13-60 months post transplant.
Greater than 110 months Post-transplant Vaccine	Influenza vaccine	Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine greater than 110 months post transplant.
Healthy Controls	Influenza vaccine	Healthy controls to measure normal immune response to the influenza vaccine

Primary Outcome Measures

Name	Time	Method
Antibody response to influenza vaccine	Each season

Secondary Outcome Measures

Name	Time	Method
T cell response to influenza vaccine antigens	Each season for the first two seasons

Trial Locations

Locations (1)

University of Wisconsin; 🇺🇸 Madison, Wisconsin, United States