Inflammatory Responses in Normal Volunteers and Patients With Abnormal Immune Responses

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by National Institutes of Health Clinical Center (CC)
Information provided by:
National Institutes of Health Clinical Center (CC) Identifier:
First received: November 3, 1999
Last updated: September 10, 2014
Last verified: September 2014

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.

Healthy Volunteers
Abnormal Phagocyte Function

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

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

Primary Outcome Measures:
  • To identify mediators that contribute to the inflammatory process and granuloma formation by comparing mediators collected from healthy volunteers to patients with abnormal regulation of inflammation and patients with host defense defects. [ Time Frame: Ongoing ] [ Designated as safety issue: No ]

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 healthy 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.


Ages Eligible for Study:   6 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes

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


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.


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


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.


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

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00001257

Contact: Mary E Garofalo, R.N. (301) 827-9758
Contact: Kol A Zarember, Ph.D. (301) 402-1802

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   
Sponsors and Collaborators
Principal Investigator: Kol A Zarember, Ph.D. National Institute of Allergy and Infectious Diseases (NIAID)
  More Information

Additional Information:
Publications: Identifier: NCT00001257     History of Changes
Other Study ID Numbers: 900120, 90-I-0120
Study First Received: November 3, 1999
Last Updated: September 10, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Normal Volunteer
Abnormal Phagocyte Function processed this record on October 19, 2014