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Protocol Details

Skin Immunity Sample Collection Involving Blisters and Biopsies

This study is NOT currently recruiting participants.

Summary | Eligibility | Citations | Contacts




Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Recruitment has not started
Gender: Male & Female
Min Age: 7
Max Age: 65

Referral Letter Required


Population Exclusion(s)



Hyper-Immunuglobulin E.Syndrome;
Chronic Granulomatous Disease;
Tumor Necrosis Factor Alpha;
Staphylococcus Aureus

Recruitment Keyword(s)



Hyper-Immunoglobulin E. Syndrome (HEIS);
Chronic Granulomatous Disease (CGD)

Investigational Drug(s)


Investigational Device(s)



Other: Blister induction
Other: Skin Biopsies

Supporting Site

National Institute of Allergy and Infectious Diseases


The way the body heals and protects itself from getting sick is called the immune response. Some people with weak immune systems get sick often or get rashes and skin infections. Researchers want to find out how the immune system and skin problems are related so they can help these people.


To learn about how immune response and skin healing are related to each other.


People ages 18-65 with hyper IgE syndrome or Job syndrome or people ages 7-65 with chronic granulomatous disease. Healthy volunteers ages 18 65 are also needed.


Participants will be screened with:

Medical history

Physical exam

Possible urine tests

Participants will have 1 to 3 visits within about a week. Visits will include the following:

Participants will have a wells device strapped to the inside of the forearm. It will suction the skin and pull the top layer away to form 8 blisters. The skin over the blisters and the liquid inside will be collected.

Participants will have up to 4 skin biopsies. A sharp tool will remove a small plug of skin from the forearm.

Participants may have blood and urine tests.

The skin on participants skin will be rubbed with a cotton swab.

Some participants will have an overnight visit. They will have the blister device placed back on the arm. The wells will be lined up over the blister wounds. The wells will be filled with either saline or the participant s blood serum. The device will be covered and left on the arm for up to 24 hours. Doctors will periodically remove some liquid from the wells.

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1. Meets one of the following:

a. has documentation of HIES or CGD (patient populations); or

b. does not have clinically apparent evidence of an immune defect or history of invasive or recurrent S. aureus infections (healthy volunteers).

2. Between the following age limits (inclusive):

a. 18 and 65 years old for healthy volunteers;

b. 7 and 65 years old for patients with CGD;

c. 18 and 65 years old for patients with HIES.

3. Willing to allow storage of blood, RNA, bacterial and fungal cultures, and other tissue samples for future research.

4. Able to provide informed consent.


The following exclusion criteria apply to all subjects:

1. For individuals undergoing blister or skin biopsy procedures, history of keloid formation.

2. Current or prior (within 3 months) anticoagulant or anti-platelet therapy (other than aspirin or non-steroidal anti-inflammatory drugs [NSAIDs]).

3. Current or prior (within 3 months) use of immunomodulatory drugs (e.g., chemotherapy, steroids), except if approved by the principal investigator.

4. Pregnancy.

5. Any condition that, in the opinion of the investigator, contraindicates participation in the study.

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Klevens RM, Morrison MA, Nadle J, Petit S, Gershman K, Ray S, Harrison LH, Lynfield R, Dumyati G, Townes JM, Craig AS, Zell ER, Fosheim GE, McDougal LK, Carey RB, Fridkin SK; Active Bacterial Core surveillance (ABCs) MRSA Investigators. Invasive methicillin-resistant Staphylococcus aureus infections in the United States. JAMA. 2007 Oct 17;298(15):1763-71.

Naimi TS, LeDell KH, Como-Sabetti K, Borchardt SM, Boxrud DJ, Etienne J, Johnson SK, Vandenesch F, Fridkin S, O'Boyle C, Danila RN, Lynfield R. Comparison of community- and health care-associated methicillin-resistant Staphylococcus aureus infection. JAMA. 2003 Dec 10;290(22):2976-84.

Myles IA, Datta SK. Staphylococcus aureus: an introduction. Semin Immunopathol. 2012 Mar;34(2):181-4. doi: 10.1007/s00281-011-0301-9. Epub 2012 Jan 27.

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Principal Investigator

Referral Contact

For more information:

Ian A. Myles, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
(301) 451-8420

Ashleigh A. Sun
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 12C103
10 Center Drive
Bethesda, Maryland 20892
(301) 605-2896

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: TTY Users Dial 7-1-1

Clinical Trials Number:


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