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

Completed

• Conditions: Healthy

• Registration Number: NCT00320164
• Lead Sponsor: Weill Medical College of Cornell University

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 Timeline

• Study Start: 2006-01
• Study First Submitted: 2006-04-27
• Study First Submitted QC: 2006-04-27
• Study First Posted: 2006-05-03
• Primary Completion: 2008-01
• Study Completion: 2008-01
• Status Verified: 2017-05
• Last Update Submitted: 2017-05-23
• Last Update Posted: 2017-05-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 8

Inclusion Criteria

• All study subjects must be capable of providing informed consent.
• Normal male or female, age 18 and older.
• Not taking corticosteroids
• Not taking any prescription or over-the-counter medication, except acetaminophen (tylenol)
• Participants of Group A must have adequate peripheral veins for leukapheresis
• Study subjects should not be taking experimental medications.
• Females cannot be pregnant.

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Exclusion Criteria

• Individuals who do not meet the inclusion criteria will be unable to participate in the protocol.
• Individuals with active infection in the 3 weeks prior to beginning the protocol will not be able to participate.
• Individuals with evidence of significant cardiac, pulmonary, renal, endocrine, central nervous system, major psychiatric disorder that would prevent compliance or substance abuse, musculoskeletal disease or immunodeficiency disease, (including evidence of human immunodeficiency virus infection, HIV) will be unable to participate in the protocol.
• Individuals participating in any other experimental clinical studies.
• Women who are pregnant or nursing.
• Active or recent drug users

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified