ClinicalTrials.gov
skipnavHome|Search|Browse|Resources|Help|What's New|About

Comparison of Immune Response in Normal Volunteers and Patients with Helminth Infections

This study is currently recruiting patients.

Sponsored by: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: Warren G Magnuson Clinical Center (CC)

Purpose

This study will compare the structure, chemical composition and other characteristics of skin and blood in people with and without parasitic infections. Cell samples will be taken from blisters produced by suction blistering. This study may provide new information about the interactions between parasites and the immune system that could lead to better treatments for these infections.

Normal volunteers and patients with acute helminth (a type of parasite) infections aged 18 years older may be eligible for this study. Participants will undergo suction blistering to provide cells needed for study. A suction blister device is attached to the skin of the thigh or forearm. A heating element in the device heats the skin to speed blister formation. (This will feel only a slightly warm.) The device is removed after about two hours, when the blisters have formed. Fluid from the blisters is drawn with a syringe, and the blister tops are removed with scissors. The blistered areas are then treated with special dressings to promote healing and the participant is discharged with further wound care instructions. A small amount of blood (around four tablespoons) may be drawn to compare chemicals in the blood with chemicals in the blister fluid. Participants will be contacted by telephone over the next 72 hours to check on healing.

Up to 60 blisters may be produced over a one-year period (in three separate sessions every six months) with no more than 20 raised per session.

Condition
Healthy
Helminthiasis

MedlinePlus related topics:  Parasitic Diseases

Study Type: Observational
Study Design: Natural History

Official Title: Langherhans' Cell Function and Inflammatory Responses in Skin of Normal Volunteers and Patients with Helminth Infections Using the Suction Blister Technique

Further Study Details: 

Expected Total Enrollment:  80

Study start: March 20, 2000

Acute helminth infections are invariably associated with profound elevations in peripheral blood eosinophilia and serum levels of IgE, responses mediated in large part by the cytokines IL-4 and IL-5 (Th2 type cytokines). To understand the nature of the early interaction between Th-2 inducing helminth parasites and host antigen presenting cells, particularly dendritic cells, we propose to isolate human dendritic cells from normal human skin and assess their function upon first exposure to live infective-stage parasites in order to mimic as closely as possible the earliest interaction between helminth parasites and the immune system. Using equipment to create suction blisters, we plan to collect skin blister fluid and skin blister roofs (containing the epidermal Langerhans' cells from normal volunteers (initially). These skin roofs will then be processed such that the Langerhans' cells can be obtained and analyzed for the responses to infectious stage live parasites in vitro. The approach to analysis will include: 1) mRNA analysis for a multitude of cytokines and chemokines using both Taqman and microarray technology; 2) supernatant production of appropriate cytokines, chemokines and other important mediators; 3) changes in surface phenotypes using standard flow cytometric techniques; 4) assessment by microscopy (confocal and immunofluorescence) of the internalization of antigen and its processing; and 5) demonstration of their ability to mature in response to antigen and to prime naive T cells. Additional studies are envisage using skin blisters and Langerhans' cells from patients with acute helminth infections to assess the role of these infections on Langerhans' cell function and to compare these skin dwelling dendritic cells to those obtained from normal individuals.

Eligibility

Genders Eligible for Study:  Both

Accepts Healthy Volunteers

Criteria

INCLUSION CRITERIA:
1. Age greater than or equal to 18 years
2. Access to a primary medical care provider outside of the NIH
3. Able to give informed consent
EXCLUSION CRITERIA:
1. History of malignancy or autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum
2. Use of systemic corticosteroids within the past month
3. Use of local corticosteroids at the proposed blistering site within the past month
4. Evidence of current acute infection
5. Personal or family history of keloid formation
6. Use of any investigative drugs within the past month
7. History of skin disease within the past one year (e.g. psoriasis, atopic dermatitis)
8. History of diabetes

Location and Contact Information


Maryland
      National Institute of Allergy and Infectious Diseases (NIAID), 9000 Rockville Pike,  Bethesda,  Maryland,  20892,  United States; Recruiting
Patient Recruitment and Public Liaison Office  1-800-411-1222    prpl@mail.cc.nih.gov 
TTY  1-866-411-1010 

More Information

Detailed Web Page

Publications

Kiistala U. Suction blister device for separation of viable epidermis from dermis. J Invest Dermatol. 1968 Feb;50(2):129-37. No abstract available.

Blauvelt A, Katz SI, Udey MC. Human Langerhans cells express E-cadherin. J Invest Dermatol. 1995 Feb;104(2):293-6.

Dale DC, Wolff SM. Skin window studies of the acute inflammatory responses of neutropenic patients. Blood. 1971 Aug;38(2):138-42. No abstract available.

Study ID Numbers:  000099; 00-I-0099
Record last reviewed:  February 25, 2004
Last Updated:  February 25, 2004
Record first received:  March 22, 2000
ClinicalTrials.gov Identifier:  NCT00004996
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2004-11-08
line
U.S. National Library of Medicine, Contact NLM Customer Service
National Institutes of Health, Department of Health & Human Services
Copyright, Privacy, Accessibility, Freedom of Information Act