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

Primary Purpose

Healthy, Helminthiasis

Status
Completed
Phase
Locations
United States
Study Type
Observational
Intervention
Sponsored by
National Institute of Allergy and Infectious Diseases (NIAID)
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Healthy focused on measuring Antigen Presentation, Cytokines, Helminth, Healthy Volunteer, Cross-Over Study, Helminth Infection

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

INCLUSION CRITERIA: Between the ages of 18 and 65 years inclusive Access to a primary medical care provider outside of the NIH Able to give informed consent Willingness to have history and physical examination annually EXCLUSION CRITERIA: History of malignancy or autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum Use of systemic corticosteroids within the past month Use of local corticosteroids at the proposed blistering site within the past month Evidence of current acute infection Personal or family history of keloid formation Use of any investigative drugs within the past month History of skin disease within the past one year (e.g. psoriasis, atopic dermatitis) History of diabetes

Sites / Locations

  • National Institutes of Health Clinical Center, 9000 Rockville Pike

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
March 22, 2000
Last Updated
December 11, 2019
Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
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1. Study Identification

Unique Protocol Identification Number
NCT00004996
Brief Title
Comparison of Immune Response in Normal Volunteers and Patients With Helminth Infections
Official Title
Langherhans' Cell Function and Inflammatory Responses in Skin of Volunteers Using the Suction Blister Technique
Study Type
Observational

2. Study Status

Record Verification Date
April 22, 2015
Overall Recruitment Status
Completed
Study Start Date
March 20, 2000 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
April 22, 2015 (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)

4. Oversight

5. Study Description

Brief Summary
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. Following a medical history and physical exam, participants will undergo suction blistering to provide cells needed for study. A suction blister device is attached to the skin of the thigh. 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. The blister tops are removed with sterile 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. Further follow-up will occur by phone at 6 months and 1 year. 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....
Detailed Description
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. Following a medical history and physical exam, participants will undergo suction blistering to provide cells needed for study. A suction blister device is attached to the skin of the thigh. 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. The blister tops are removed with sterile 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. Further follow-up will occur by phone at 6 months and 1 year. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Helminthiasis
Keywords
Antigen Presentation, Cytokines, Helminth, Healthy Volunteer, Cross-Over Study, Helminth Infection

7. Study Design

Enrollment
90 (Actual)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
INCLUSION CRITERIA: Between the ages of 18 and 65 years inclusive Access to a primary medical care provider outside of the NIH Able to give informed consent Willingness to have history and physical examination annually EXCLUSION CRITERIA: History of malignancy or autoimmune disease such as rheumatoid arthritis, vasculitis, pyoderma gangrenosum Use of systemic corticosteroids within the past month Use of local corticosteroids at the proposed blistering site within the past month Evidence of current acute infection Personal or family history of keloid formation Use of any investigative drugs within the past month History of skin disease within the past one year (e.g. psoriasis, atopic dermatitis) History of diabetes
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas B Nutman, M.D.
Organizational Affiliation
National Institute of Allergy and Infectious Diseases (NIAID)
Official's Role
Principal Investigator
Facility Information:
Facility Name
National Institutes of Health Clinical Center, 9000 Rockville Pike
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20892
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
4868034
Citation
Kiistala U. Suction blister device for separation of viable epidermis from dermis. J Invest Dermatol. 1968 Feb;50(2):129-37. doi: 10.1038/jid.1968.15. No abstract available.
Results Reference
background
PubMed Identifier
7829887
Citation
Blauvelt A, Katz SI, Udey MC. Human Langerhans cells express E-cadherin. J Invest Dermatol. 1995 Feb;104(2):293-6. doi: 10.1111/1523-1747.ep12612830.
Results Reference
background
PubMed Identifier
4933314
Citation
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.
Results Reference
background

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

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