Inflammatory Responses in Normal Volunteers and Patients With Abnormal Immune Responses

This study is currently recruiting participants.
Verified September 2013 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00001257
First received: November 3, 1999
Last updated: March 14, 2014
Last verified: September 2013
  Purpose

This study will investigate the inflammatory response. People with abnormal regulation of inflammation and immune defects often have an exaggerated or depressed inflammatory response that results in poor healing of recurrent infections. This study will measure and compare amounts of inflammatory mediators (chemicals involved in the inflammatory response) in healthy normal volunteers and in patients with abnormal immune responses.

Healthy normal volunteers and patients with host defense defects or excessive inflammation, as in vasculitis syndromes, may be eligible for this study. Patients must be between 6 and 65 years of age.

Participants will have eight small blisters raised on the forearm using a gentle suction device. The top of the blisters will be removed with scissors and a plastic template will be placed over the blisters. The wells of the template will be filled with a salt solution or a mixture of the subject s serum (fluid part of the blood without cells) and a salt solution. Some blisters may be covered with coverslips a small round piece of very thin sterilized glass before adding the fluid. Blister fluid will be removed from the wells at 3, 5, 8, and 24 hours with a syringe and analyzed for inflammatory mediators. A scab will form over the blisters and fall off in about 2 weeks.

Participants will have about 4 tablespoons of blood drawn in order to compare the inflammatory mediators in the blood with those in the blister fluid.


Condition
Healthy
Inflammation
Vasculitis

Study Type: Observational
Official Title: Comparison of Inflammatory Responses in Normal Volunteers and Patients With Abnormal Phagocyte Function Using the Suction Blister Technique

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Estimated Enrollment: 200
Study Start Date: April 1990
Detailed Description:

Patients with abnormal regulation of inflammation and with host defense defects often have an exaggerated or depressed inflammatory response with resultant difficulty in healing of recurrent infections. Delayed healing can be manifested by either a delay in wound healing, granuloma formation along the incision line, or dehiscence of a partially healed wound without evidence of infection. We are interested in studying the dynamics of host immune defenses during an experimentally induced inflammatory response using a well-studied suction blister device. This protocol is designed to study mediators of inflammation in patients with host defense defects as well as patients with excessive inflammation as in the vasculitis syndromes. We will measure mediators of inflammation (e.g., C5a, leukotriene B4, interleukins, chemokines, tumor necrosis factor, interferon-gamma) by ELISA, radioimmunoassay, High Performance Liquid Chromatography, multiplex cytokine assays, and/or bioactivity assays. Furthermore, molecular characterization and host defense functions (e.g., respiratory burst, chemotaxis, phagocytosis, microbicidal activity) of cells recruited to the blisters will also be examined. In addition to the analysis of cell function, RNA will be prepared and subject to DNA microarray or quantitative RT-PCR studies to measure expression and dynamics of key inflammatory mediators. Many of these factors contribute to the inflammatory process and several are thought to be important in granuloma formation. If patients are found to have abnormal amounts of these mediators when compared to normal volunteers or patients with other abnormalities it will help us understand the basis for their disease and new therapeutic strategies. For example, this blister study allowed us to identify a patient subsequently shown to have IRAK4 deficiency.

  Eligibility

Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria
  • INCLUSION CRITERIA - PATIENTS:

Patients having or thought to have an immune defect between the ages of 6 and 65 years (inclusive) are eligible to participate.

INCLUSION CRITERIA - NORMAL VOLUNTEERS:

Be a healthy adult of either sex and between the ages of 18 and 65 years old.

Weight greater than 110 pounds.

Not have any heart, lung, or kidney disease, or bleeding disorders.

Not have a history of viral hepatitis (B or C) since age 11.

Not have a history of intravenous injection drug use.

Not have a history of engaging in high-risk activities for exposure to the AIDS virus.

Not be pregnant.

EXCLUSION CRITERIA - PATIENTS:

Patients less than 6 or greater than 65 years of age.

EXCLUSION CRITERIA - NORMAL VOLUNTEER:

Less than 18 years old or older than 65 years.

Have viral hepatitis (B or C).

HIV positive.

Receiving chemotherapeutic agent(s), or have underlying malignancy.

Pregnant.

Have history of heart, lung, kidney disease, or bleeding disorders.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00001257

Contacts
Contact: Mary E Garofalo, R.N. (301) 827-9758 mgarofalo@mail.nih.gov
Contact: Kol A Zarember, Ph.D. (301) 402-1802 kz29m@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Kol A Zarember, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00001257     History of Changes
Other Study ID Numbers: 900120, 90-I-0120
Study First Received: November 3, 1999
Last Updated: March 14, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Lymphokines
LTB4
Inflammation
Normal Volunteer
Abnormal Phagocyte Function

Additional relevant MeSH terms:
Inflammation
Vasculitis
Pathologic Processes
Vascular Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on April 16, 2014