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Influenza Vaccine in Lung Transplant Patients

This study has been completed.
Information provided by (Responsible Party):
Mary Hayney, University of Wisconsin, Madison Identifier:
First received: September 13, 2005
Last updated: June 17, 2013
Last verified: June 2013

Research Question: How do antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation and healthy individuals?

Experimental Design: This interventional parallel group study will compare influenza vaccine induced immune responses in three groups: lung transplant patients, individuals waiting for lung transplantation and healthy individuals.

Current and Future Research Activities: Blood will be drawn for these measures of vaccine induced antibody response before and 2 to 4 weeks after immunization. Another blood draw will be obtained from up to 30 individuals from among the three groups for measures of T cell response to immunization. The third blood draw will be done during months 1 to 5 following influenza immunization. Genetic material (DNA) will be obtained from cells in the blood to look for genetic markers that may be associated with influenza vaccine response. Blood draws and immunization for the healthy participants will be done at the General Clinical Research Center (GCRC) or in the Clinical Research Facility in Rennebohm Hall. The blood draws for the pre-transplant and post-transplant patients will be coordinated with clinically indicated laboratory tests in order to avoid additional venipunctures. Influenza immunization is part of the routine clinical care of patients with lung disease, and only the immune response data will be considered part of the research study.

Condition Intervention
Influenza Drug: Influenza vaccine

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Influenza Vaccine in Lung Transplant Patients

Resource links provided by NLM:

Further study details as provided by Mary Hayney, University of Wisconsin, Madison:

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

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

Enrollment: 152
Study Start Date: December 2004
Study Completion Date: July 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Influenza vaccine
    influenza vaccine 0.5 ml intramuscularly each season

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00205270

United States, Wisconsin
University of Wisconsin
Madison, Wisconsin, United States, 53792
Sponsors and Collaborators
University of Wisconsin, Madison
Principal Investigator: Mary S Hayney, PharmD University of Wisconsin, Madison
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Mary Hayney, Professor of Pharmacy, University of Wisconsin, Madison Identifier: NCT00205270     History of Changes
Other Study ID Numbers: 2004-0240
Study First Received: September 13, 2005
Last Updated: June 17, 2013

Keywords provided by Mary Hayney, University of Wisconsin, Madison:
Pre or post-lung transplant

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Immunologic Factors
Physiological Effects of Drugs processed this record on September 21, 2017