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Influenza Vaccine in Lung Transplant Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00205270
Enrollment
126
Registered
2005-09-20
Start date
2004-12-31
Completion date
2009-07-31
Last updated
2020-10-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Pre or post-lung transplant, Healthy

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.

Interventions

DRUGInfluenza vaccine

influenza vaccine 0.5 ml intramuscularly each season

Sponsors

University of Wisconsin, Madison
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frame
Antibody response to influenza vaccineEach season

Secondary

MeasureTime frame
T cell response to influenza vaccine antigensEach season for the first two seasons

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026