Influenza Vaccine in Lung Transplant Patients - T Cells

• Sponsor: University of Wisconsin, Madison (Other)
• Overall Status: Completed
• CT.gov ID: NCT04533061
• Collaborator: (none)
• Enrollment: 24
• Location: 1
• Duration (Months): 55
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Influenza	Drug: Influenza vaccine

Detailed 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]

Study Design

• Study Type: Observational
• Actual Enrollment: 24 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Lung Transplant Patients' T Cell Responses to Influenza Vaccine Viruses Between Seasons
• Study Start Date: Dec 1, 2004
• Actual Primary Completion Date: Jul 1, 2009
• Actual Study Completion Date: Jul 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Lung Transplant, Vaccine Cohort consist of individuals who have received lung transplants 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
Healthy Control, 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

Outcome Measures

Primary Outcome Measures

1. Antibody response to influenza vaccine [2-4 weeks post-immunization (2004-2005 season), up to 1 year (2-4 weeks post-immunization, 2005-2006 season)]

   Blood was drawn prior to and 2-4 weeks after immunization and used to measure antibody responses by hemagglutination inhibition assay

2. T cell response to influenza vaccine antigens [between January and April 2005, between January and April 2006]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Wisconsin	Madison	Wisconsin	United States	53792

Sponsors and Collaborators

• University of Wisconsin, Madison

Investigators

• Principal Investigator: Mary S Hayney, PharmD, University of Wisconsin, Madison

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT04533061
• Other Study ID Numbers: H-2004-0240a; A561000; PHARM/PHARMACY/PHARMACY
• First Posted: Aug 31, 2020
• Last Update Posted: Oct 23, 2020
• Last Verified: Oct 1, 2020

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University of Wisconsin, Madison: Lung transplant; Healthy
• Additional relevant MeSH terms: Influenza, Human

Study Results

No Results Posted as of Oct 23, 2020