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| ID | Type | Description | Link |
|---|---|---|---|
| A561000 | Other Identifier | UW Madison | |
| PHARM/PHARMACY/PHARMACY | Other Identifier | UW Madison |
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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 study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients between seasons.
In the recent past, immunization policy-making bodies advised against immunizing too early in the influenza season because vaccine-specific antibody may wane before the end of the influenza season. This recommendation was based on only a small amount of data in frail elderly individuals, and further examination of the evidence shows that influenza vaccine antibody may last much longer. The influenza immunization timing recommendation is now changed to immunize when vaccine is available and continue throughout the season.
These changes led the investigators to the question of duration of influenza vaccine-induced antibody in lung transplant patients. No published studies of antibody persistence in this population could be found.
As part of a 5-year study of influenza antibody response in lung transplant patients, in patients awaiting lung transplantation, and in healthy controls, serum was obtained before and 2-4 weeks after influenza immunization for each season. Therefore, a serum sample was collected on each participant approximately 11 months after influenza vaccine administration for each of 4 years.
To investigate duration of influenza antibody titers, antibody concentrations to the previous season's vaccine antigens were measured.
The hypothesis is that immunosuppressed lung transplant patients would maintain protective concentrations of influenza antigen-specific antibodies (an antibody titer of at least 1:40) beyond the influenza season.
[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results]
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vaccine, Pre-transplant | cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually. |
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| Vaccine, Post-transplant | Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually. |
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| Vaccine, Healthy Controls | Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Drug | influenza vaccine 0.5 ml intramuscularly each season: 2004-2005, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens |
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| Measure | Description | Time Frame |
|---|---|---|
| Influenza Vaccine Seroprotection at 11 months post immunization | A protective influenza antibody concentration is a titer of greater than or equal to 1:40. Influenza antibody concentrations were measured using hemagglutination inhibition assays. | up to 11 months |
| Measure | Description | Time Frame |
|---|---|---|
| Antibody Concentrations Measured by Geometric Mean Titer | 2-4 weeks post immunization, up to 11 months |
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Inclusion Criteria:
Exclusion Criteria:
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Healthy adult or patient receiving care pre- or post-lung transplant at University of Wisconsin Hospital
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| Name | Affiliation | Role |
|---|---|---|
| Mary S Hayney, PharmD | University of Wisconsin, Madison | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Wisconsin | Madison | Wisconsin | 53792 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21615847 | Result | Moran JJ, Rose WE, Darga AJ, Rohde KA, Hayney MS. Persistence of influenza vaccine-induced antibodies in lung transplant patients between seasons. Transpl Infect Dis. 2011 Oct;13(5):466-70. doi: 10.1111/j.1399-3062.2011.00654.x. Epub 2011 May 27. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |