Influenza Vaccine in Lung Transplant Patients - Seroprotection

NCT04531657 | Completed FDA Drug

• 4 other identifiers: H-2004-0240eA561000PHARM/PHARMACY/PHARMACY2009-0002
• Study Type: observational
• Target: 79
• Locations: 1 country
• Sites: 1

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 two different definitions of influenza vaccine seroprotection at mid-season in lung transplant patients.

Conditions

Influenza

Keywords

Post-lung transplant; Healthy

Outcome Measures

Primary Outcomes (1)

• Number of Participants with Seroprotection to Influenza Vaccine: 40 HAU

  The hypothesis is that seroprotection, defined as 40 HAU or greater, will persist up to 6 months at high rates in lung transplant patients and that these rates will be comparable to the rates in healthy individuals. Seroprotection (antibody titer greater than or equal to 1:40) will be reported for H1N1, H3N2, and B viral antigens.

  up to 6 months

Secondary Outcomes (1)

• Number of Participants with Seroprotection to Influenza Vaccine: 160 HAU

  up to 6 months

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 vaccine DRUG

influenza vaccine 0.5 ml intramuscularly during 2008-2009 season for measurement of A/Brisbane/59/2007(H1N1)-like, A/Brisbane/10/2007(H3N2)-like, and B/Florida/4/2006-like antigens

Vaccine, Healthy Control; Vaccine, Post-transplant

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult or patient receiving care post-lung transplant at 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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: 25148380 RESULT

MeSH Terms

Conditions

Influenza, Human

Interventions

Influenza Vaccines

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex 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)