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

NCT ID: NCT00320164

Last Updated: 2017-05-24

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 8 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2006-01-31
• Study Completion Date: 2008-01-31

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.

Conditions

Healthy

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: PROSPECTIVE

Study Groups

Group A: Leukapheresis

Subject's peripheral blood mononuclear cells are collected via leukapheresis.

No interventions assigned to this group

Group B: Buffy Coats Collection

Subject's peripheral blood mononuclear cells are collected via the buffy coats from blood.

No interventions assigned to this group

Eligibility Criteria

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.

• 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Weill Medical College of Cornell University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Neil R. Hackett, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

Weill Medical College of Cornell University

Other Identifiers

Dendritic Cells

Identifier Type: -

Identifier Source: org_study_id