Influenza Vaccine in Lung Transplant Patients - Seroprotection

Influenza Clinical Trial

Official title:

Influenza Vaccine Antibody Response and 6-month Persistence in Lung Transplant Recipients Using Two Definitions of Seroprotection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531657
• Other study ID #: H-2004-0240e
• Secondary ID: A561000PHARM/PHA
• Status: Completed
• Start date: December 2004
• Est. completion date: July 2009

Study information

• Verified date: October 2020
• Source: University of Wisconsin, Madison
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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]

Recruitment information / eligibility

• Status: Completed
• Enrollment: 79
• Est. completion date: July 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

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

Locations

Country	Name	City	State
United States	University of Wisconsin	Madison	Wisconsin

Sponsors (1)

Lead Sponsor	Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Number of Participants with Seroprotection to Influenza Vaccine: 160 HAU	Seroprotection (antibody titer greater than or equal to 1:160) will be reported for H1N1, H3N2, and B viral antigens.	up to 6 months