NCT00205270

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
126

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
10 months until next milestone

First Submitted

Initial submission to the registry

September 13, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 20, 2005

Completed
3.8 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
Last Updated

October 23, 2020

Status Verified

October 1, 2020

Enrollment Period

4.6 years

First QC Date

September 13, 2005

Last Update Submit

October 20, 2020

Conditions

Influenza

Keywords

Pre or post-lung transplantHealthy

Outcome Measures

Primary Outcomes (1)

  • Antibody response to influenza vaccine

    Each season

Secondary Outcomes (1)

  • T cell response to influenza vaccine antigens

    Each season for the first two seasons

Study Arms (5)

Pre-transplant Vaccine

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

Drug: Influenza vaccine

0-6 Months Post-transplant Vaccine

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

Drug: Influenza vaccine

13-60 months Post-transplant Vaccine

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

Drug: Influenza vaccine

Greater than 110 months Post-transplant Vaccine

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

Drug: Influenza vaccine

Healthy Controls

Healthy controls to measure normal immune response to the influenza vaccine

Drug: Influenza vaccine

Interventions

Influenza vaccineDRUG

influenza vaccine 0.5 ml intramuscularly each season

0-6 Months Post-transplant Vaccine13-60 months Post-transplant VaccineGreater than 110 months Post-transplant VaccineHealthy ControlsPre-transplant Vaccine

Eligibility Criteria

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

Healthy adults and patients receiving care pre- or post-lung transplant at University of Wisconsin Hospital

You may qualify if:

  • Receiving care pre- or 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 (6)

  • Dopp JM, Wiegert NA, Moran JJ, Francois ML, Radford KL, Thomas H, Love RB, Hayney MS. Effect of annual influenza immunization on antibody response in lung transplant patients. Prog Transplant. 2009 Jun;19(2):153-9. doi: 10.1177/152692480901900209.

    PMID: 19588665RESULT

  • Hayney MS, Moran J, Wiegert NA, Burlingham WJ. Lung transplant patients' T cell responses to influenza vaccine viruses between seasons. Vaccine. 2008 May 19;26(21):2596-600. doi: 10.1016/j.vaccine.2008.03.012. Epub 2008 Mar 31.

    PMID: 18420314RESULT

  • 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.

    PMID: 21615847RESULT

  • 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

  • Long AJ, Worzella SL, Moran JJ, Hayney MS. Influenza vaccine antibody response and 6-month persistence in lung transplant recipients using two definitions of seroprotection. Transplantation. 2015 Apr;99(4):885-9. doi: 10.1097/TP.0000000000000391.

    PMID: 25148380RESULT

  • Miller RM, Rohde KA, Tingle MT, Moran JJ, Hayney MS. Antibody responses to influenza vaccine in pre- and post-lung transplant patients. Clin Transplant. 2016 May;30(5):606-12. doi: 10.1111/ctr.12726. Epub 2016 Mar 20.

    PMID: 26928266RESULT

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

September 13, 2005

First Posted

September 20, 2005

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)