Influenza Vaccine in Lung Transplant Patients

October 20, 2020 updated by: University of Wisconsin, Madison

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Wisconsin
      • Madison, Wisconsin, United States, 53792
        • University Of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Healthy adults and patients receiving care pre- or post-lung transplant at University of Wisconsin Hospital

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antibody response to influenza vaccine
Time Frame: Each season
Each season

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Wisconsin, Madison

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2004

Primary Completion (Actual)

July 1, 2009

Study Completion (Actual)

July 1, 2009

Study Registration Dates

First Submitted

September 13, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 20, 2005

Study Record Updates

Last Update Posted (Actual)

October 23, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-2004-0240
  • A561000 (Other Identifier: UW Madison)
  • PHARM/PHARMACY/PHARMACY (Other Identifier: UW Madison)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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