Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00133510
Status:
COMPLETED
Last Update Posted:
2010-08-27
First Post:
2005-08-19
Brief Title:
Influenza Vaccine in Pediatric Transplant Subjects
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
Prospective Comparative Study of the Humoral and Cell-Mediated Immune Responses to the Trivalent Subviron Influenza Vaccine in Pediatric Liver Transplant Recipients as an Indicator for Response of Immunocompromised Subjects to Vaccination Against Agents of Bioterrorism
Status:
COMPLETED
Status Verified Date:
2008-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate how well children responds to the recommended trivalent subviron influenza vaccine flu shot Children who have had a liver transplant and receive their post-transplant care at Mount Sinai and their siblings are being invited to participate in this study Study procedures will include a review of medical records physical examination and up to 2 flu shots All participants will receive the flu vaccine Four weeks after the first flu shot participants will return to the clinic for a physical exam blood sample collection and a second flu shot as recommended Following each vaccination parents will be asked to record their childrens temperatures and any experienced side effects in a diary card for two weeks Participants will be involved in study related procedures for up to 8 months
Detailed Description:
The purpose of this study is to investigate the humoral and cell-mediated immune response to the trivalent subviron influenza vaccine in pediatric liver transplant recipients Additionally researchers will attempt to correlate the humoral and cell-mediated immune response with parameters that may predict a subjects ability to respond to the vaccine such as time from transplant immunosuppressive agents previous episodes of rejection or cytomegalovirus infection T-cell numbers and T-cell responses to mitogens or antigens Understanding the immune response to influenza will provide insight not only into the response to the trivalent subviron influenza vaccine but to other vaccines being developed against agents of bioterrorism in particular those that may use influenza or related viruses as a backbone This is a single center prospective comparative study of the humoral and cell-mediated immune responses to the trivalent subviron influenza vaccine for the 2004-2005 and 2005-2006 influenza seasons in outpatient pediatric liver transplant recipients and their healthy siblings There are two study arms the liver transplant recipients n44 and the healthy controls n22 All study subjects will receive the vaccine at enrollment Enrollment into this study will be extended into the 2005-2006 influenza season The trivalent subviron influenza vaccine for the 2005-2006 influenza season will differ from that for the 2004-2005 influenza season with respect to the H3N2 viral strains The cell-mediated and humoral immune responses of patients to the two H3N2 viral strains will be analyzed together and separately to assess potential differences in immunogenicity between the two viral strains 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 Participants will be involved in study related procedures for up to 8 months
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None