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Completed

NCT Number: NCT04530786

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Wisconsin

Madison, Wisconsin, 53792, United States

About this study

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]

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Influenza vaccine

Drug

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

Primary outcomes

  1. Antibody response to influenza vaccine

    Time frame: season 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.

  2. Antibody response to influenza vaccine

    Time frame: season 2 (up to 2 years 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.

  3. Antibody response to influenza vaccine

    Time frame: season 2 (up to 2.5 years 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.

  4. Antibody response to influenza vaccine

    Time frame: season 3 (up to 3 years 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.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

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

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Aug 28, 2020
Registry last updated
Oct 23, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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