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Completed

NCT Number: NCT04533061

Influenza Vaccine in Lung Transplant Patients - T Cells

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 trial is designed to investigate the hypothesis that there is no difference in T Cell response to the influenza vaccine between lung transplant patients and healthy controls.

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Key information

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

Influenza virus infection causes significant morbidity and mortality each season. The infection is particularly serious in the elderly and those with chronic cardiopulmonary conditions. Solid organ transplant recipients receiving immunosuppressive therapy may be at particularly high risk for serious influenza infection. Lung transplant patients may have an even higher risk because of their underlying pathophysiology.

Influenza prophylaxis is extremely important in the care of the transplant patient. Annual influenza immunization is recommended because protection is short-lived and the vaccine composition changes. However, the efficacy and effectiveness of this intervention is largely unproven. Not surprisingly, studies have shown that lung transplant patients have lower antibody responses than healthy individuals do. To this end, this study tests the hypothesis that the influenza vaccine-induced T cell responses will be similar in lung transplant patients and healthy individuals.

Blood will be drawn prior to and 2-4 weeks after immunization and used to measure antibody responses by hemagglutination inhibition assay.

Samples will be collected in Jan-April each season to study Trans-vivo Delayed Type Hypersensitivity (TVDTH) response.

[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

  • 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

2004-2005 season contains: A/New Caledonia/20/99 (H1N1)-like, A/Fujian/411/2002 (H3N2-like), and B/Shanghai/361/2002-like antigens

2005-2006 season contains: A/New Caledonia/20/99 (H1N1)-like, A/California/7/2004 (H3N2), and B/Shanghai/361/2002-like antigens

Primary outcomes

  1. Antibody response to influenza vaccine

    Time frame: 2-4 weeks post-immunization (2004-2005 season), up to 1 year (2-4 weeks post-immunization, 2005-2006 season)

    Blood was drawn prior to and 2-4 weeks after immunization and used to measure antibody responses by hemagglutination inhibition assay

  2. T cell response to influenza vaccine antigens

    Time frame: between January and April 2005, between January and April 2006

    T cell response is measured with trans-vivo delayed-type hypersensitivity assay (TVDTH). To induce TVDTH responses, prepared lymphocytes were injected into the footpads of anesthetized (isoflurane) severe combined immunodeficiency (SCID) mice using a 0.5 ml syringe with a 28-gauge needle. The resulting swelling is an index of human T cell sensitization.

Sponsors and collaborators

Lead sponsor

University of Wisconsin, Madison

Other

Registry information

Official study title

Lung Transplant Patients' T Cell Responses to Influenza Vaccine Viruses Between Seasons

Important dates

Study start
2004
Primary completion
2009
Study completion
2009
First posted
Aug 31, 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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