Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies

Influenza Clinical Trial

Official title:

Persistence of Influenza Vaccine-induced Antibodies in Lung Transplant Patients Between Seasons

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04531787
• Other study ID #: H-2004-0240c
• Secondary ID: A561000PHARM/PHA
• Status: Completed
• Start date: August 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 influenza vaccine-induced antibodies in lung transplant patients between seasons.

Description:

In the recent past, immunization policy-making bodies advised against immunizing too early in the influenza season because vaccine-specific antibody may wane before the end of the influenza season. This recommendation was based on only a small amount of data in frail elderly individuals, and further examination of the evidence shows that influenza vaccine antibody may last much longer. The influenza immunization timing recommendation is now changed to immunize when vaccine is available and continue throughout the season.

These changes led the investigators to the question of duration of influenza vaccine-induced antibody in lung transplant patients. No published studies of antibody persistence in this population could be found.

As part of a 5-year study of influenza antibody response in lung transplant patients, in patients awaiting lung transplantation, and in healthy controls, serum was obtained before and 2-4 weeks after influenza immunization for each season. Therefore, a serum sample was collected on each participant approximately 11 months after influenza vaccine administration for each of 4 years.

To investigate duration of influenza antibody titers, antibody concentrations to the previous season's vaccine antigens were measured.

The hypothesis is that immunosuppressed lung transplant patients would maintain protective concentrations of influenza antigen-specific antibodies (an antibody titer of at least 1:40) beyond the influenza season.

[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: 139
• 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 pre- or 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 each season: 2004-2005, 2005-2006, 2006-2007, 2007-2008 for season specific A/H1N1, A/H3N2, and B 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)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Antibody Concentrations Measured by Geometric Mean Titer		2-4 weeks post immunization, up to 11 months