Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies

NCT04531787 | Completed FDA Drug

• 3 other identifiers: H-2004-0240cA561000PHARM/PHARMACY/PHARMACY
• Study Type: observational
• Target: 139
• 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 influenza vaccine-induced antibodies in lung transplant patients between seasons.

Conditions

Influenza

Keywords

Pre or post-lung transplant; Healthy

Outcome Measures

Primary Outcomes (1)

• Influenza Vaccine Seroprotection at 11 months post immunization

  A protective influenza antibody concentration is a titer of greater than or equal to 1:40. Influenza antibody concentrations were measured using hemagglutination inhibition assays.

  up to 11 months

Secondary Outcomes (1)

• Antibody Concentrations Measured by Geometric Mean Titer

  2-4 weeks post immunization, up to 11 months

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, Healthy Controls

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 each season: 2004-2005, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B antigens

Vaccine, Healthy Controls; Vaccine, Post-transplant; Vaccine, Pre-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 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

Sponsors & Collaborators

• University of Wisconsin, Madison: lead

Study Sites (1)

University of Wisconsin

Madison, Wisconsin, 53792, United States

Location

Related Publications (1)

• 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: 21615847 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: August 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)