Influenza Vaccine in Lung Transplant Patients

University of Wisconsin (UW)

Status: Completed

Conditions: Influenza

Treatments: Drug: Influenza vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT00205270

H-2004-0240

PHARM/PHARMACY/PHARMACY (Other Identifier)

A561000 (Other Identifier)

Details and patient eligibility

About

This 5-year study was 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.

Full description

[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data]

Although pre-transplant immunization is routinely recommended, this recommendation is based on little data. The primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant.

This prospective cohort study is to include immunization events performed over five years to measure H1N1, H3N2, and B antibody responses to the influenza vaccine in pre- and post-lung transplant patients. The pre-transplant patients will move to the post-transplant group as the study progressed. Similarly, participants are allowed to move to the next time-since-transplant group as time elapsed.

Serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season.

Geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.

Enrollment: 126 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

126 participants in 5 patient groups

Pre-transplant Vaccine

Description:

Cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.

Treatment:

Drug: Influenza vaccine

0-6 Months Post-transplant Vaccine

Description:

Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 0-6 months post transplant.

Treatment:

Drug: Influenza vaccine

13-60 months Post-transplant Vaccine

Description:

Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 13-60 months post transplant.

Treatment:

Drug: Influenza vaccine

Greater than 110 months Post-transplant Vaccine

Description:

Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine greater than 110 months post transplant.

Treatment:

Drug: Influenza vaccine

Healthy Controls

Description:

Healthy controls to measure normal immune response to the influenza vaccine

Treatment:

Drug: Influenza vaccine