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Influenza Vaccine in Lung Transplant Patients

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ClinicalTrials.gov Identifier: NCT00205270
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Brief Summary:
This 5-year study was 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.

Condition or disease Intervention/treatment
Influenza Drug: Influenza vaccine

Detailed Description:

[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data]

Although pre-transplant immunization is routinely recommended, this recommendation is based on little data. The primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant.

This prospective cohort study is to include immunization events performed over five years to measure H1N1, H3N2, and B antibody responses to the influenza vaccine in pre- and post-lung transplant patients. The pre-transplant patients will move to the post-transplant group as the study progressed. Similarly, participants are allowed to move to the next time-since-transplant group as time elapsed.

Serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season.

Geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.

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Study Type : Observational
Actual Enrollment : 126 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Antibody Responses to Influenza Vaccine in Pre- and Post-lung Transplant Patients
Study Start Date : December 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
Pre-transplant Vaccine
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

0-6 Months Post-transplant Vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 0-6 months post transplant.
Drug: Influenza vaccine
influenza vaccine 0.5 ml intramuscularly each season

13-60 months Post-transplant Vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 13-60 months post transplant.
Drug: Influenza vaccine
influenza vaccine 0.5 ml intramuscularly each season

Greater than 110 months Post-transplant Vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine greater than 110 months post transplant.
Drug: Influenza vaccine
influenza vaccine 0.5 ml intramuscularly each season

Healthy Controls
Healthy controls to measure normal immune response to the influenza vaccine
Drug: Influenza vaccine
influenza vaccine 0.5 ml intramuscularly each season




Primary Outcome Measures :
  1. Antibody response to influenza vaccine [ Time Frame: Each season ]

Secondary Outcome Measures :
  1. T cell response to influenza vaccine antigens [ Time Frame: Each season for the first two seasons ]


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 adults and patients 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): NCT00205270


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: NCT00205270    
Other Study ID Numbers: H-2004-0240
A561000 ( Other Identifier: UW Madison )
PHARM/PHARMACY/PHARMACY ( Other Identifier: UW Madison )
First Posted: September 20, 2005    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
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases