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 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.
[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.
2,214 studies on the registry are indexed under Influenza, Human; 163 are open to participants now.
This study's enrollment of 126 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.
Healthy adults and patients receiving care pre- or post-lung transplant at University of Wisconsin Hospital
Exclusion Criteria:
Cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.
Drug: Influenza vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 0-6 months post transplant.
Drug: Influenza vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 13-60 months post transplant.
Drug: Influenza vaccine
Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine greater than 110 months post transplant.
Drug: Influenza vaccine
Healthy controls to measure normal immune response to the influenza vaccine
Drug: Influenza vaccine
influenza vaccine 0.5 ml intramuscularly each season
Antibody response to influenza vaccine
Time frame: Each season
T cell response to influenza vaccine antigens
Time frame: Each season for the first two seasons
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