Ignite Creation Date:
2024-05-05 @ 4:50 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00320164
Status:
COMPLETED
Last Update Posted:
2017-05-24
First Post:
2006-04-27
Brief Title:
Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals
Sponsor:
Weill Medical College of Cornell University
Organization:
Weill Medical College of Cornell University
Study Overview
Official Title:
Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals
Status:
COMPLETED
Status Verified Date:
2017-05
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:
This protocol aims to collect human peripheral blood mononuclear cells for the production of dendritic cells DC There are two ways to collect human peripheral blood mononuclear cells in this protocol One is by using the method of leukapheresis from normal healthy adults The other is by drawing the blood from normal healthy adults and then getting the buffy coats from the blood
Detailed Description:
One objective of these studies on DC is to complete a preclinical development for a human study of a candidate anti-Pseudomonas aeruginosa vaccine consisting of autologous dendritic cells primed with heat-inactivated P aeruginosa PA strain POA1 and expressing the T-cell costimulatory molecule CD40 ligand CD40L The other objective is to complete a preclinical development for a human study of a candidate anti-anthrax vaccine Prior to testing the vaccine in humans the Food and Drug Administration will require preclinical and Good Manufacturing Practice GMP practice batches of dendritic cells The intent of the leukapheresis or collecting the buffy coats is to provide the biological materials for this purpose
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