NCT04533139

Brief Summary

This is 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 prospective, parallel study was done to investigate the responses to influenza vaccine in consecutive years.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
122

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
6 days until next milestone

First Posted

Study publicly available on registry

August 31, 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

Pre or post-lung transplantHealthy

Outcome Measures

Primary Outcomes (1)

  • Log-transformed change in Antibody Responses

    Influenza antibody concentrations are measured by HIA in samples taken before immunization and 2 to 4 weeks later. Antibody response is the difference in serum concentrations from before and 2 to 4 weeks after vaccination. Antibody concentrations were compared between seasons by using a Wilcoxon rank sum test.

    baseline, 2-4 weeks post-vaccination (2004-2005 season), up to 1 year, up to 1 year and 4 weeks (2005-2006 season)

Secondary Outcomes (3)

  • Incidence of Seroconversion

    2-4 weeks post-vaccination (2004-2005 season), up to 1 year and 4 weeks (post-vaccination 2005-2006 season)

  • Incidence of Seroprotection

    baseline, 2-4 weeks post-vaccination (2004-2005 season), up to 1 year, up to 1 year and 4 weeks (2005-2006 season)

  • Correlation of Time Since Transplantation to Antibody Response in Lung Transplant Patients

    2-4 weeks post-vaccination (2004-2005 season), up to 1 year and 4 weeks (post-vaccination 2005-2006 season)

Study Arms (3)

Vaccine, pre-transplant

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

Drug: Influenza vaccine

Vaccine, post-transplant

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

Drug: Influenza vaccine

Vaccine, not receiving transplant

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 2004-2005 season antigens: A/New Caledonia/20/99(H1N1)-like, A/Wyoming/3/2003(H3N2), and B/Shanghai/361/2002-like antigens 2005-2006 season antigens: A/New Caledonia/ 20/00(H1N1)-like, A/California/7/2004 (H3N2)-like, and B/Shanghai/361/2002-like antigens

Vaccine, not receiving transplantVaccine, post-transplantVaccine, pre-transplant

Eligibility Criteria

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

Healthy adults, or 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 (1)

  • 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

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 31, 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)