Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies Beyond the Season

Influenza Clinical Trial

Official title:

Persistence of Influenza Vaccine-induced Antibody in Lung Transplant Patients and Healthy Individuals Beyond the Season

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04530786
• Other study ID #: H-2004-0240d
• 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 influenza vaccine-induced antibodies in lung transplant patients beyond the season of vaccination.

Description:

Every year influenza infection causes significant morbidity and mortality in the general population making it a serious public health concern. Among those at highest risk for complications from infection are the immunocompromised. Effective influenza immunization that confers protection throughout the season is critical for lung transplant recipients because in addition to aggressive immunosuppressive therapy, infection directly affects the transplanted organ. Studies of influenza vaccine response rates in lung transplant patients show generally lower antibody concentrations, but acceptable influenza vaccine response rates compared with healthy individuals. However, little is known about the persistence of influenza vaccine-induced antibody concentration in either healthy or immunosuppressed populations. Influenza antibody concentrations persist at seroprotective levels (defined as antibody concentrations at least 40 hemagglutination units) up to a year post vaccination. However, the investigators could find no information regarding persistence beyond one year. It is hypothesized that the high rates of persisting influenza vaccine antibody in immunosuppressed lung transplant individuals would match the rates of persisting vaccine-antibody in healthy individuals. Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually (individual participants followed for 3 years). Samples were collected at 2-4 weeks post-vaccination. Seroprotection was defined as a titer of ≥ 1:40 and was compared between groups over the measured term using Fisher's exact tests. [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: 100
• 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 each season, antigens measured for 3 years following vaccination in: 2004-2005: A/Wyoming H3N2; B/Shanghai 2006-2007: A/New Caledonia H1N1 2007-2008: A/Solomon Islands; A/Wisconsin H3N2; B/Malaysia

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)

Severson JJ, Richards KR, Moran JJ, Hayney MS. Persistence of influenza vaccine-induced antibody in lung transplant patients and healthy individuals beyond the season. Hum Vaccin Immunother. 2012 Dec 1;8(12):1850-3. doi: 10.4161/hv.21735. Epub 2012 Aug 21 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibody response to influenza vaccine	Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.	season 1 (up to 1 year on study)
Primary	Antibody response to influenza vaccine	Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.	season 2 (up to 2 years on study)
Primary	Antibody response to influenza vaccine	Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.	season 2 (up to 2.5 years on study)
Primary	Antibody response to influenza vaccine	Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.	season 3 (up to 3 years on study)