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Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04531787
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

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.


Condition or disease Intervention/treatment
Influenza Drug: Influenza vaccine

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]

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Study Type : Observational
Actual Enrollment : 139 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Persistence of Influenza Vaccine-induced Antibodies in Lung Transplant Patients Between Seasons
Study Start Date : August 2004
Actual Primary Completion Date : July 2009
Actual Study Completion Date : July 2009

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
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, 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, 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Antibody Concentrations Measured by Geometric Mean Titer [ Time Frame: 2-4 weeks post immunization, up to 11 months ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Healthy adult or patient receiving care pre- or post-lung transplant at University of Wisconsin Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04531787


Locations
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United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Investigators
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Principal Investigator: Mary S Hayney, PharmD University of Wisconsin, Madison
Publications of Results:
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Responsible Party: University of Wisconsin, Madison
ClinicalTrials.gov Identifier: NCT04531787    
Other Study ID Numbers: H-2004-0240c
A561000 ( Other Identifier: UW Madison )
PHARM/PHARMACY/PHARMACY ( Other Identifier: UW Madison )
First Posted: August 28, 2020    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Wisconsin, Madison:
Pre or post-lung transplant
Healthy
Additional relevant MeSH terms:
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Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases