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Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals

Healthy Clinical Trial

Official title:
Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals

Clinical Trial 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.

Clinical Trial 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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00320164
Study type Observational
Source Weill Medical College of Cornell University
Contact
Status Completed
Phase N/A
Start date January 2006
Completion date January 2008
View Details
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