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Influenza Vaccine in Lung Transplant Patients - Seroprotection

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ClinicalTrials.gov Identifier: NCT04531657
Recruitment Status : Completed
First Posted : August 28, 2020
Last Update Posted : October 23, 2020
Sponsor:
Information provided by (Responsible Party):
University of Wisconsin, Madison

Tracking Information
First Submitted Date August 25, 2020
First Posted Date August 28, 2020
Last Update Posted Date October 23, 2020
Study Start Date December 2004
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 25, 2020)
Number of Participants with Seroprotection to Influenza Vaccine: 40 HAU [ Time Frame: up to 6 months ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: August 25, 2020)
Number of Participants with Seroprotection to Influenza Vaccine: 160 HAU [ Time Frame: up to 6 months ]
Seroprotection (antibody titer greater than or equal to 1:160) will be reported for H1N1, H3N2, and B viral antigens.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Influenza Vaccine in Lung Transplant Patients - Seroprotection
Official Title Influenza Vaccine Antibody Response and 6-month Persistence in Lung Transplant Recipients Using Two Definitions of Seroprotection
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.

Detailed Description

Given the significant risk of morbidity and mortality, it is critical and highly recommended that lung transplant patients receive annual influenza immunizations that confer protection throughout the influenza season. Previous studies have demonstrated that transplant recipients and nonimmunocompromised populations display similar rates of seroprotection between 3 and 5 weeks after influenza vaccination, despite the transplant population achieving generally lower antibody concentrations. Two studies show influenza vaccine antibody persistence at reasonable rates at 1 year, but not 2 years, after immunization. However, there are no studies comparing seroprotection rates 6 months after vaccination, reflecting adequate coverage throughout the entire influenza season.

Seroprotection has traditionally been defined as an antibody concentration of at least 40 hemagglutination units (HAU) after vaccination, which is the criterion for influenza vaccine licensure. This concentration of antibody provides protection from infection at a rate of about 50% in typically healthy individuals. Protection from infection improves with higher antibody concentrations. For this study, a HAU of at least 160 was selected as a more conservative definition of seroprotection, where protection may reach up to 95%.

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. As a secondary outcome, seroprotection rates are compared when 160 HAU or greater was used to define seroprotection.

Influenza vaccine responses in lung transplant patients and healthy control subjects without lung disease will be compared over the course of the 2008 to 2009 influenza season.

Serum collected from participants before immunization, 2 to 4 weeks after immunization (postimmunization), and 6 months after immunization.

[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results]

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Healthy adult or patient receiving care post-lung transplant at University of Wisconsin Hospital
Condition Influenza
Intervention Drug: Influenza vaccine
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
Study Groups/Cohorts
  • Vaccine, Post-transplant
    Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.
    Intervention: Drug: Influenza vaccine
  • Vaccine, Healthy Control
    Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually.
    Intervention: Drug: Influenza vaccine
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 25, 2020)
79
Original Actual Enrollment Same as current
Actual Study Completion Date July 2009
Actual Primary Completion Date July 2009   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Allergy to eggs
  • Moderate to severe febrile illness
  • Active treatment for acute rejection
  • Received season's influenza vaccine prior to enrollment
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT04531657
Other Study ID Numbers H-2004-0240e
A561000 ( Other Identifier: UW Madison )
PHARM/PHARMACY/PHARMACY ( Other Identifier: UW Madison )
2009-0002 ( Registry Identifier: Institutional Review Board )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party University of Wisconsin, Madison
Study Sponsor University of Wisconsin, Madison
Collaborators Not Provided
Investigators
Principal Investigator: Mary S Hayney, PharmD University of Wisconsin, Madison
PRS Account University of Wisconsin, Madison
Verification Date October 2020