An observational study in Influenza, sponsored by University of Wisconsin, Madison. Completed at 1 site in United States. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-23.
Sponsored by University of Wisconsin, Madison · Observational
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.
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]
2,214 studies on the registry are indexed under Influenza, Human; 164 are open to participants now.
This study's enrollment of 24 is below the median of 300 across 305 observational studies indexed under Influenza, Human.
Browse Influenza, Human studies →University of Wisconsin, Madison is the lead sponsor of 1,161 studies on the registry; 182 are open to participants now.
Of its 151 completed or terminated interventional studies of FDA-regulated products, 114 (75%) have results posted.
Counted across the registry records on this site, refreshed daily.
Post-lung transplant patients at the UW Hospital and healthy adults
Exclusion Criteria:
Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.
Drug: Influenza vaccine
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 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
Antibody response to influenza vaccine
Blood was drawn prior to and 2-4 weeks after immunization and used to measure antibody responses by hemagglutination inhibition assay
Time frame: 2-4 weeks post-immunization (2004-2005 season), up to 1 year (2-4 weeks post-immunization, 2005-2006 season)
T cell response to influenza vaccine antigens
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.
Time frame: between January and April 2005, between January and April 2006
Plan to share: No
This study is completed, as verified in Oct 2020. You cannot join it, but the record below documents what was studied.
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University of Wisconsin, Madison