Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04531787

Enrollment

139

Registered

2020-08-28

Start date

2004-08-31

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 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.

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

Interventions

DRUGInfluenza 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

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

Measure	Time frame	Description
Influenza Vaccine Seroprotection at 11 months post immunization	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.

Secondary

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

Countries

United States

Outcome results

None listed

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