Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies

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

Persistence of Influenza Vaccine-induced Antibodies in Lung Transplant Patients Between Seasons

This a sub-study of a 5-year study 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.

This study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients between seasons.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

In the recent past, immunization policy-making bodies advised against immunizing too early in the influenza season because vaccine-specific antibody may wane before the end of the influenza season. This recommendation was based on only a small amount of data in frail elderly individuals, and further examination of the evidence shows that influenza vaccine antibody may last much longer. The influenza immunization timing recommendation is now changed to immunize when vaccine is available and continue throughout the season.

These changes led the investigators to the question of duration of influenza vaccine-induced antibody in lung transplant patients. No published studies of antibody persistence in this population could be found.

As part of a 5-year study of influenza antibody response in lung transplant patients, in patients awaiting lung transplantation, and in healthy controls, serum was obtained before and 2-4 weeks after influenza immunization for each season. Therefore, a serum sample was collected on each participant approximately 11 months after influenza vaccine administration for each of 4 years.

To investigate duration of influenza antibody titers, antibody concentrations to the previous season's vaccine antigens were measured.

The hypothesis is that immunosuppressed lung transplant patients would maintain protective concentrations of influenza antigen-specific antibodies (an antibody titer of at least 1:40) beyond the influenza season.

[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results]

Study Type

Observational

Enrollment (Actual)

139

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 adult or patient 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
Vaccine, Post-transplant
Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.
Drug: Influenza vaccine
influenza vaccine 0.5 ml intramuscularly each season: 2004-2005, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens
Vaccine, Pre-transplant
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: 2004-2005, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens
Vaccine, Healthy Controls
Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually.
Drug: Influenza vaccine
influenza vaccine 0.5 ml intramuscularly each season: 2004-2005, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influenza Vaccine Seroprotection at 11 months post immunization
Time Frame: up to 11 months
A protective influenza antibody concentration is a titer of greater than or equal to 1:40. Influenza antibody concentrations were measured using hemagglutination inhibition assays.
up to 11 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Antibody Concentrations Measured by Geometric Mean Titer
Time Frame: 2-4 weeks post immunization, up to 11 months
2-4 weeks post immunization, up to 11 months

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

August 1, 2004

Primary Completion (ACTUAL)

July 1, 2009

Study Completion (ACTUAL)

July 1, 2009

Study Registration Dates

First Submitted

August 25, 2020

First Submitted That Met QC Criteria

August 25, 2020

First Posted (ACTUAL)

August 28, 2020

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-2004-0240c
  • 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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