NCT04530786

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 beyond the season of vaccination.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2004

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2004

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2009

Completed
11.2 years until next milestone

First Submitted

Initial submission to the registry

August 25, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 28, 2020

Completed
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

4.6 years

First QC Date

August 25, 2020

Last Update Submit

October 20, 2020

Conditions

Influenza

Keywords

post-lung transplantHealthyimmunocompromised

Outcome Measures

Primary Outcomes (4)

  • Antibody response to influenza vaccine

    Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.

    season 1 (up to 1 year on study)

  • Antibody response to influenza vaccine

    Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.

    season 2 (up to 2 years on study)

  • Antibody response to influenza vaccine

    Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.

    season 2 (up to 2.5 years on study)

  • Antibody response to influenza vaccine

    Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.

    season 3 (up to 3 years on study)

Study Arms (2)

Vaccine, Post-transplant

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

Drug: Influenza vaccine

Vaccine, Healthy Control

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

Drug: Influenza vaccine

Interventions

Influenza vaccineDRUG

influenza vaccine 0.5 ml intramuscularly each season, antigens measured for 3 years following vaccination in: * 2004-2005: A/Wyoming H3N2; B/Shanghai * 2006-2007: A/New Caledonia H1N1 * 2007-2008: A/Solomon Islands; A/Wisconsin H3N2; B/Malaysia

Vaccine, Healthy ControlVaccine, Post-transplant

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Receiving care Post-lung transplant at University of Wisconsin Hospital
  • Healthy adult

You may not qualify if:

  • Allergy to eggs
  • Moderate to severe febrile illness
  • Active treatment for acute rejection
  • Received season's influenza vaccine prior to enrollment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

  • Severson JJ, Richards KR, Moran JJ, Hayney MS. Persistence of influenza vaccine-induced antibody in lung transplant patients and healthy individuals beyond the season. Hum Vaccin Immunother. 2012 Dec 1;8(12):1850-3. doi: 10.4161/hv.21735. Epub 2012 Aug 21.

    PMID: 22906937RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral VaccinesVaccinesBiological ProductsComplex Mixtures

Study Officials

  • Mary S Hayney, PharmD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 25, 2020

First Posted

August 28, 2020

Study Start

December 1, 2004

Primary Completion

July 1, 2009

Study Completion

July 1, 2009

Last Updated

October 23, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

US(1)