Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies

• ClinicalTrials.gov Identifier: NCT04531787
• Recruitment Status: Completed
• First Posted: August 28, 2020
• Last Update Posted: October 23, 2020
• Sponsor: University of Wisconsin, Madison
• Information provided by (Responsible Party): University of Wisconsin, Madison

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 study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients between seasons.

Condition or disease	Intervention/treatment
Influenza	Drug: Influenza vaccine

Detailed Description:

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]

Study Design

• Study Type: Observational
• Actual Enrollment: 139 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Persistence of Influenza Vaccine-induced Antibodies in Lung Transplant Patients Between Seasons
• Study Start Date: August 2004
• Actual Primary Completion Date: July 2009
• Actual Study Completion Date: July 2009

Groups and Cohorts

Group/Cohort	Intervention/treatment
Vaccine, Pre-transplant; cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.	Drug: Influenza vaccine; 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
Vaccine, Post-transplant; 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, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens
Vaccine, Healthy Controls; 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, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens

Outcome Measures

Primary Outcome Measures :

1. Influenza Vaccine Seroprotection at 11 months post immunization [ Time Frame: up to 11 months ]
   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.

Secondary Outcome Measures :

1. Antibody Concentrations Measured by Geometric Mean Titer [ Time Frame: 2-4 weeks post immunization, up to 11 months ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult or patient receiving care pre- or post-lung transplant at University of Wisconsin Hospital

Criteria

Inclusion Criteria:

• Receiving care pre- or 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

United States, Wisconsin

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

More Information

Publications of Results:

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.

• Responsible Party: University of Wisconsin, Madison
• ClinicalTrials.gov Identifier: NCT04531787
• Other Study ID Numbers: H-2004-0240c; A561000 ( Other Identifier: UW Madison ); PHARM/PHARMACY/PHARMACY ( Other Identifier: UW Madison )
• First Posted: August 28, 2020
• Last Update Posted: October 23, 2020
• Last Verified: October 2020

Individual Participant Data (IPD) Sharing Statement:

• 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:

Pre or post-lung transplant; Healthy

Additional relevant MeSH terms:

Influenza, Human; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Infections; Respiratory Tract Diseases