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Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies Beyond the Season

Persistence of Influenza Vaccine-induced Antibody in Lung Transplant Patients and Healthy Individuals Beyond the Season

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04530786
Enrollment
100
Registered
2020-08-28
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

post-lung transplant, Healthy, immunocompromised

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 beyond the season of vaccination.

Detailed description

Every year influenza infection causes significant morbidity and mortality in the general population making it a serious public health concern. Among those at highest risk for complications from infection are the immunocompromised. Effective influenza immunization that confers protection throughout the season is critical for lung transplant recipients because in addition to aggressive immunosuppressive therapy, infection directly affects the transplanted organ. Studies of influenza vaccine response rates in lung transplant patients show generally lower antibody concentrations, but acceptable influenza vaccine response rates compared with healthy individuals. However, little is known about the persistence of influenza vaccine-induced antibody concentration in either healthy or immunosuppressed populations. Influenza antibody concentrations persist at seroprotective levels (defined as antibody concentrations at least 40 hemagglutination units) up to a year post vaccination. However, the investigators could find no information regarding persistence beyond one year. It is hypothesized that the high rates of persisting influenza vaccine antibody in immunosuppressed lung transplant individuals would match the rates of persisting vaccine-antibody in healthy individuals. Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually (individual participants followed for 3 years). Samples were collected at 2-4 weeks post-vaccination. Seroprotection was defined as a titer of ≥ 1:40 and was compared between groups over the measured term using Fisher's exact tests. \[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results\]

Interventions

DRUGInfluenza vaccine

influenza vaccine 0.5 ml intramuscularly each season, antigens measured for 3 years following vaccination in: * 2004-2005: A/Wyoming H3N2; B/Shanghai * 2006-2007: A/New Caledonia H1N1 * 2007-2008: A/Solomon Islands; A/Wisconsin H3N2; B/Malaysia

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 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 frameDescription
Antibody response to influenza vaccineseason 1 (up to 1 year on study)Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.

Countries

United States

Outcome results

None listed

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