Clinical trial NCT00205270: Influenza Vaccine in Lung Transplant Patients
Official title: Antibody Responses to Influenza Vaccine in Pre- and Post-lung Transplant Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Keywords: Pre or post-lung transplant
Healthy
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
First posted: 2005-09-20
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Healthy adults and patients receiving care pre- or post-lung transplant at University of Wisconsin Hospital

Brief summary: This 5-year study was 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.

Detailed description: \[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data\]

Although pre-transplant immunization is routinely recommended, this recommendation is based on little data. The primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant.

This prospective cohort study is to include immunization events performed over five years to measure H1N1, H3N2, and B antibody responses to the influenza vaccine in pre- and post-lung transplant patients. The pre-transplant patients will move to the post-transplant group as the study progressed. Similarly, participants are allowed to move to the next time-since-transplant group as time elapsed.

Serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season.

Geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.

Eligibility criteria: 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

Primary outcomes:
measure: Antibody response to influenza vaccine
timeFrame: Each season
Secondary outcomes:
measure: T cell response to influenza vaccine antigens
timeFrame: Each season for the first two seasons
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Mary S Hayney, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dopp JM, Wiegert NA, Moran JJ, Francois ML, Radford KL, Thomas H, Love RB, Hayney MS. Effect of annual influenza immunization on antibody response in lung transplant patients. Prog Transplant. 2009 Jun;19(2):153-9. doi: 10.1177/152692480901900209.
citation: Hayney MS, Moran J, Wiegert NA, Burlingham WJ. Lung transplant patients' T cell responses to influenza vaccine viruses between seasons. Vaccine. 2008 May 19;26(21):2596-600. doi: 10.1016/j.vaccine.2008.03.012. Epub 2008 Mar 31.
citation: 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.
citation: 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.
citation: 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.
citation: Miller RM, Rohde KA, Tingle MT, Moran JJ, Hayney MS. Antibody responses to influenza vaccine in pre- and post-lung transplant patients. Clin Transplant. 2016 May;30(5):606-12. doi: 10.1111/ctr.12726. Epub 2016 Mar 20.