Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies Beyond the Season

University of Wisconsin (UW)

Status: Completed

Conditions: Influenza

Treatments: Drug: Influenza vaccine

Study type: Observational

Funder types: Other

Identifiers

NCT04530786

H-2004-0240d

PHARM/PHARMACY/PHARMACY (Other Identifier)

A561000 (Other Identifier)

Details and patient eligibility

About

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 beyond the season of vaccination.

Full description

Every year influenza infection causes significant morbidity and mortality in the general population making it a serious public health concern. Among those at highest risk for complications from infection are the immunocompromised. Effective influenza immunization that confers protection throughout the season is critical for lung transplant recipients because in addition to aggressive immunosuppressive therapy, infection directly affects the transplanted organ. Studies of influenza vaccine response rates in lung transplant patients show generally lower antibody concentrations, but acceptable influenza vaccine response rates compared with healthy individuals. However, little is known about the persistence of influenza vaccine-induced antibody concentration in either healthy or immunosuppressed populations.

Influenza antibody concentrations persist at seroprotective levels (defined as antibody concentrations at least 40 hemagglutination units) up to a year post vaccination. However, the investigators could find no information regarding persistence beyond one year.

It is hypothesized that the high rates of persisting influenza vaccine antibody in immunosuppressed lung transplant individuals would match the rates of persisting vaccine-antibody in healthy individuals.

Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually (individual participants followed for 3 years). Samples were collected at 2-4 weeks post-vaccination. Seroprotection was defined as a titer of ≥ 1:40 and was compared between groups over the measured term using Fisher's exact tests.

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

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Receiving care 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

100 participants in 2 patient groups

Vaccine, Post-transplant

Description:

Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.

Treatment:

Drug: Influenza vaccine

Vaccine, Healthy Control

Description:

Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually.

Treatment:

Drug: Influenza vaccine