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

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ClinicalTrials.gov Identifier: NCT00320164
Recruitment Status : Completed
First Posted : May 3, 2006
Last Update Posted : May 24, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
Healthy

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 Type : Observational
Actual Enrollment : 8 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Anti-Pseudomonas Immune Status and Dendritic Cell Preparation in Normal Individuals
Study Start Date : January 2006
Primary Completion Date : January 2008
Study Completion Date : January 2008

Group/Cohort
Group A: Leukapheresis
Subject's peripheral blood mononuclear cells are collected via leukapheresis.
Group B: Buffy Coats Collection
Subject's peripheral blood mononuclear cells are collected via the buffy coats from blood.




Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Group A is for leukapheresis and Group B is for buffy coats collection. We will use either Group A or Group B or both to collect mononuclear cells. The source of potential subjects in both groups will be normal individuals recruited from the population of healthy individuals. Accrual will be random with no bias as to gender or racial/ethnic group. Nevertheless, because the accrual process will be random, it is possible that there may be differences in the proportion of males and females, and racial/ethnic groups. The study volunteers will be recruited through IRB approved advertisements placed in local newspapers and fliers. All efforts will be made to recruit women and minorities.
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.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00320164


Sponsors and Collaborators
Weill Medical College of Cornell University
Investigators
Principal Investigator: Neil R. Hackett, Ph.D. Weill Medical College of Cornell University

Responsible Party: Weill Medical College of Cornell University
ClinicalTrials.gov Identifier: NCT00320164     History of Changes
Other Study ID Numbers: Dendritic Cells
First Posted: May 3, 2006    Key Record Dates
Last Update Posted: May 24, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Weill Medical College of Cornell University:
Healthy Volunteers

Additional relevant MeSH terms:
Pseudomonas Infections
Gram-Negative Bacterial Infections
Bacterial Infections