Clinical trial NCT04531787: Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies
Official title: Persistence of Influenza Vaccine-induced Antibodies in Lung Transplant Patients Between Seasons
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Pre or post-lung transplant
Healthy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2020-08-28
Enrollment: 139
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adult or patient receiving care pre- or post-lung transplant at University of Wisconsin Hospital

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.

\[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results\]

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

Primary outcomes:
measure: Influenza Vaccine Seroprotection at 11 months post immunization
timeFrame: up to 11 months
Secondary outcomes:
measure: Antibody Concentrations Measured by Geometric Mean Titer
timeFrame: 2-4 weeks post immunization, up to 11 months
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mary S Hayney, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.