Influenza Vaccine in Lung Transplant Patients - T Cells

Influenza Clinical Trial

Official title:

Lung Transplant Patients' T Cell Responses to Influenza Vaccine Viruses Between Seasons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04533061
• Other study ID #: H-2004-0240a
• Secondary ID: A561000PHARM/PHA
• Status: Completed
• Start date: December 2004
• Est. completion date: July 2009

Study information

• Verified date: October 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Intervention

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & Publications (1)

Hayney MS, Moran J, Wiegert NA, Burlingham WJ. Lung transplant patients' T cell responses to influenza vaccine viruses between seasons. Vaccine. 2008 May 19;26(21):2596-600. doi: 10.1016/j.vaccine.2008.03.012. Epub 2008 Mar 31. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	2-4 weeks post-immunization (2004-2005 season), up to 1 year (2-4 weeks post-immunization, 2005-2006 season)
Primary	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.	between January and April 2005, between January and April 2006