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

Tracking Information

• First Submitted Date: August 25, 2020
• First Posted Date: August 28, 2020
• Last Update Posted Date: October 23, 2020
• Study Start Date: August 2004
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: August 25, 2020)

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.

• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures (submitted: August 25, 2020): Antibody Concentrations Measured by Geometric Mean Titer [ Time Frame: 2-4 weeks post immunization, up to 11 months ]
• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies
• Official Title: Persistence of Influenza Vaccine-induced Antibodies in Lung Transplant Patients Between Seasons

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.

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 Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Healthy adult or patient receiving care pre- or post-lung transplant at University of Wisconsin Hospital
• Condition: Influenza

Intervention

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

Study Groups/Cohorts

• Vaccine, Pre-transplant
  cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.
  Intervention: Drug: Influenza vaccine
• Vaccine, Post-transplant
  Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.
  Intervention: Drug: Influenza vaccine
• Vaccine, Healthy Controls
  Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually.
  Intervention: Drug: Influenza vaccine

• Publications *: 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.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: October 20, 2020): 139
• Original Actual Enrollment (submitted: August 25, 2020): 157
• Actual Study Completion Date: July 2009
• Actual Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04531787
• Other Study ID Numbers: H-2004-0240c; A561000 ( Other Identifier: UW Madison ); PHARM/PHARMACY/PHARMACY ( Other Identifier: UW Madison )
• Has Data Monitoring Committee: No

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: University of Wisconsin, Madison
• Study Sponsor: University of Wisconsin, Madison
• Collaborators: Not Provided

Investigators

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

• PRS Account: University of Wisconsin, Madison
• Verification Date: October 2020