Ignite Creation Date:
2024-05-05 @ 4:53 PM
Last Modification Date:
2024-10-26 @ 9:25 AM
Study NCT ID:
NCT00337896
Status:
COMPLETED
Last Update Posted:
2013-08-16
First Post:
2006-06-15
Brief Title:
T and B Cell Response to Avian Flu Vaccine
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
T and B Cell Immune Responses to Influenza AH5N1 Vaccine
Status:
COMPLETED
Status Verified Date:
2011-04
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 substudy study is to evaluate the types of cells involved in fighting infection to the AH5N1 avian flu virus vaccine A maximum of 30 healthy adults ages 18-64 years enrolled at Stanford University Hospital and participating in another clinical trial DMID Protocol 04-062 will be enrolled into this substudy to collect additional samples of blood for testing before and approximately one week after each vaccination
Detailed Description:
A human vaccination trial involving influenza AH5N1 vaccine with different adjuvants is being conducted in a healthy adult population aged 18-64 years DMID 04-062 to test the safety reactogenicity and immunogenicity of monovalent inactivated influenza AH5N1 vaccine when given with either alone no adjuvant or given along with either alum or MF59 Two doses of the vaccineadjuvent will be administered day 0 and day 28 This study is linked to DMID protocol 04-062 This protocol is a substudy to collect additional blood samples to specifically evaluate the cell-mediated immune responses generated from the vaccine Primary goals of this study are 1 to establish reproducible functional cell-mediate immune response assays to evaluate the magnitude and functional capacity of B cells NK cells and T cells responding to monovalent subvirion H5 influenza vaccine 2 to evaluate the percent of subjects demonstrating B cell NK cell CD8 andor CD4 response The secondary goal of this study is to examine and compare the adjuvant effect of Alum or MF59 compared to no adjuvant on cell mediated immune responses
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