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Sponsored by: |
University of Wisconsin, Madison |
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Information provided by: | University of Wisconsin, Madison |
ClinicalTrials.gov Identifier: | NCT00205270 |
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 |
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Influenza |
Drug: Influenza vaccine |
Study Type: | Interventional |
Study Design: | Non-Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | Influenza Vaccine in Lung Transplant Patients |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Mary S Hayney, PharmD | mshayney@pharmacy.wisc.edu |
United States, Wisconsin | |
University of Wisconsin | Recruiting |
Madison, Wisconsin, United States, 53792 | |
Contact: Mary S Hayney, PharmD mshayney@pharmacy.wisc.edu |
Principal Investigator: | Mary S Hayney, PharmD | University of Wisconsin, Madison |
Study ID Numbers: | 2004-0240 |
Study First Received: | September 13, 2005 |
Last Updated: | October 24, 2007 |
ClinicalTrials.gov Identifier: | NCT00205270 |
Health Authority: | United States: Institutional Review Board |
Pre or post-lung transplant Healthy |
Virus Diseases Respiratory Tract Diseases Respiratory Tract Infections |
Influenza, Human Healthy Orthomyxoviridae Infections |
RNA Virus Infections |