This is a single center, prospective comparative study of the humoral and cell-mediated immune responses to the trivalent subviron influenza vaccine (Fluzone®, Aventis Pasteur, Swiftwater, PA) in outpatient pediatric liver transplant recipients and their healthy siblings. There are two study arms, the liver transplant recipients (n=44 and the healthy controls (n=-22). All study subjects will receive the vaccine at enrollment. Humoral and cell-mediated immune responses will be obtained at baseline and following immunization. Healthy siblings are used as controls to ensure equal burden of influenza disease among study participants. Additionally, data in healthy children will allow bridging of data obtained in this study with those done previously.

Condition	Intervention
Influenza	Vaccine: Trivalent Subviron Influenza vaccine (Fluzone)

Further Study Details: 

Expected Total Enrollment:  66

The purpose of this study is to evaluate the seroconversion rates and cell-mediated immune responses among pediatric liver transplant recipients immunized with the trivalent influenza vaccine. Both humoral and cell-mediated immune responses to vaccine will be measured. Baseline and post vaccination immune responses will be measured and compared. Humoral responses will be measured by hemagglutination inhibition assay for each viral strain contained within the vaccine while cell-mediated immune responses will be measured by intracellular interferon-gamma (IFN-y) ELISPOTS to influenza specific antigens. To establish the level of cell-meditated immune function predictive of immune response to the vaccine. To correlate immune response with parameters that may predict a subject''''s ability to respond to the vaccine a standardized review of the transplant recipient''''s medical record will be performed. Demographic data and data regarding the indication and course since transplantation will be extracted from the patient record. Blood for T-cell enumeration and IFN-y ELISPOTS to phytohemagglutinin (mitogen) and tetanus (antigen) will be drawn at the time of each immunization. The T-cell numbers, mean T-cell stimulation indexes and IFN-y responses to PHA and tetanus at the time of vaccination will be compared between the transplant and control groups and with an individual subject''''s own humoral and cell-mediated response to influenza vaccine to determine their predictive value of vaccine response.

Ages Eligible for Study:  6 Months   -   17 Years,  Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

Inclusion Criteria:

Study subjects must meet all of the following inclusion criteria to participate in this study.

1. Informed consent from parent/guardian and assent from participants, when applicable, must have been obtained and signed freely.
2. Between the ages of 6 months and 17 years.
3. Three months time has elapsed since liver transplantation.
4. Recipient of a liver transplant or live with a sibling who is the recipient of a liver transplant.
5. Must have the ability to comply with the study procedures for the entire length of the study.

Exclusion Criteria:

Any subject meeting any one of the exclusion criteria at enrollment or at the time of subsequent vaccination will be excluded from participation in the study. In addition, subjects who have experienced an acute febrile illness within the preceding 48 hours will have immunization deferred and be rescheduled once their fever has resolved.

Exclusion criteria include:

1. Previous immunization with an influenza vaccine for the 04-05 influenza season.
2. Known Hypersensitivity reaction to the vaccine or vaccine component including eggs or gelatin.
3. History of Guillian-Barre syndrome.
4. Receipt of an immunoglobulin product (including intravenous or intramuscular immunoglobulin preparations, cytomegalovirus hyperimmunoglobulin and varicella-zoster immunoglobulin) within 3 months of vaccination.
5. Receipt of any live viral vaccines within 4 weeks or an inactivated viral vaccine within 2 weeks of enrollment.

Please refer to this study by ClinicalTrials.gov identifier  NCT00133510

Andrew Campbell      (212) 241-4638    andrew.campbell@mssm.edu

New York
      Mount Sinai School of Medicine, New York,  New York,  10029,  United States; Recruiting

Study ID Numbers:  04-050
Last Updated:  August 22, 2005
Record first received:  August 19, 2005
ClinicalTrials.gov Identifier:  NCT00133510
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-08-23