An Early Phase 1 interventional study of Blister induction and Skin Biopsies in Hyper-Immunoglobulin E. Syndrome (HEIS) and Chronic Granulomatous Disease (CGD), sponsored by National Institute of Allergy and Infectious Diseases (NIAID). Withdrawn at 1 site in United States. Open to participants aged 7 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-12-13.
Sponsored by National Institute of Allergy and Infectious Diseases (NIAID) · Early Phase 1, Interventional, and Basic science
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Among 31 studies in Granulomatous Disease, Chronic by National Institute of Allergy and Infectious Diseases (NIAID) — 7 open to participants now, 10 under way, none of them phase 3. Granulomatous Disease, Chronic · National Institute of Allergy and Infectious Diseases (NIAID).
Among the 31 studies in Granulomatous Disease, Chronic by National Institute of Allergy and Infectious Diseases (NIAID), this one is the 23rd largest by enrollment of the 24 interventional ones that give a count, is one of 3 that started in 2024, is one of 9 in phase 1, and was the 23rd registered.
79 studies on the registry are indexed under Granulomatous Disease, Chronic; 17 are open to participants now.
Browse Granulomatous Disease, Chronic studies →7 of the 31 studies in Granulomatous Disease, Chronic by National Institute of Allergy and Infectious Diseases (NIAID) are open now, in 1 country. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–75 · Men only
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–75 · Men only
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 4–65
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Healthy volunteers
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 18–70 · Healthy volunteers
By country, each count listing its studies:
Of the 12 Granulomatous Disease, Chronic studies recruiting now, 3 (25%) set no upper age limit and 9 (75%) stop at 75 or younger; 8 take children under 18; 2 take healthy volunteers.
This study: 7 Years to 65 Years · all sexes · healthy volunteers too.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
31 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 17 · Phase 2 11 · Phase 3 2 · Phase 4 2
First in 1991; this study’s year is marked. 3 started in 2024.
By drug class, each counting the studies that test any of its medicines:
Median enrollment 10 across the 24 interventional studies, 156 across the 7 observational. Of the 17 that completed or were terminated, 3 (18%) have results posted.
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National Institute of Allergy and Infectious Diseases (NIAID) is the lead sponsor of 2,446 studies on the registry; 179 are open to participants now.
Of its 405 completed or terminated interventional studies of FDA-regulated products, 302 (75%) have results posted.
2 of the studies in Granulomatous Disease, Chronic by National Institute of Allergy and Infectious Diseases (NIAID) that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06253507National Institute of Allergy and Infectious Diseases (NIAID)pCCLCHIM-p47 (Lentiviral Vector Transduced CD34 Plus Cells) in Patients With p47 Autosomal Recessive Chronic Granulomatous Disease (AR-CGD) | 2027-03-31 |
| NCT05189925National Institute of Allergy and Infectious Diseases (NIAID)NADPH Oxidase Correction in mRNA-transfected Granulocyte-enriched Cells in Chronic Granulomatous Disease (CGD) | 2027-07-01 |
Add all 2 to your calendar (.ics) → With an account.
Among the 31 studies in Granulomatous Disease, Chronic by National Institute of Allergy and Infectious Diseases (NIAID), from their registry updates:
Nothing recorded among them since 2026-09-25.
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Background:
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.
Objective:
To learn about how immune response and skin healing are related to each other.
Eligibility:
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.
Design:
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.
The incidence of community-associated (CA) staphylococcal infections, especially those caused by methicillin-resistant Staphylococcus aureus (MRSA), has increased in recent years. Skin and soft tissues are the primary sites for these infections. Although many patients without apparent underlying immune dysfunction suffer from recurrent and persistent skin infections with S.aureus, patients with conditions such as hyper immunoglobulin E syndrome (HIES, or Job s syndrome) and chronic granulomatous disease (CGD) are disproportionately affected. Although underlying host molecular defects responsible for some of these predisposing conditions have been uncovered in recent years, the skin immune response to S. aureus infections has not been elucidated in either healthy volunteers or susceptible populations. We hypothesize that the local skin response determines susceptibility to S. aureus skin infection.
In this sample collection protocol, we will perform exploratory evaluations of anti-staphylococcal immune responses in healthy volunteers, subjects with HIES, and subjects with CGD. Following screening and baseline procedures, including blood draw and skin swab, subjects will have the option to undergo blister induction, where a suction device will be used to induce skin blisters on the forearm. The tops of the blisters and blister fluid will be collected for research testing and storage for future research. An optional overnight inpatient stay may be performed to collect additional cellular infiltrates in response to autologous serum and/or sterile saline. Subjects may also have up to 4 skin punch biopsies from the forearm over the course of a week to capture wound healing progress and identify involved genes. All research procedures will be performed at the National Institutes of Health Clinical Center (NIH CC).
The primary objective of this research is to perform ex vivo assessment of wound healing pathways using a skin blister model and skin biopsies to obtain keratinocyte cultures and evaluate skin immune responses. We will use three experimental approaches: 1) ex vivo evaluation of anti-microbial responses and tissue remodeling through derivation of keratinocyte cultures from skin blisters and biopsies, 2) in vivo and ex vivo assessment of cellular response after blister induction using overnight exposure to autologous serum and/or sterile saline, and 3) evaluation of in vivo responses to skin biopsies. We anticipate that the research will provide critical new information on the human skin immune and remodeling responses and will have direct relevance for the development of vaccines, diagnostics, and therapeutics.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Meets one of the following:
Between the following age limits (inclusive):
EXCLUSION CRITERIA:
The following exclusion criteria apply to all subjects:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Biopsy and archival tissue
A biopsy takes a small piece of tissue to examine. “Archival tissue” is a sample already taken, for example at diagnosis, and kept by the hospital.
Whether a stored sample will do depends on when it was taken, how much there is and what the study needs. Ask whether the study accepts your stored sample or needs a new biopsy.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Blister Induction
Other: Blister induction
Skin Biopsies
Other: Skin Biopsies
Blister induction involves creating 8 blisters on the forearm and removing the tops of the blisters for primary cell culture derivation. After blister induction, subjects may have an optional overnight admission to assess cell infiltration in response to autologous serum and/or sterile saline solution.
The skin biopsies will involve up to 4 biopsies: 2 initial punch biopsies 2 mm in diameter, followed by a punch biopsy 3 (plus or minus 1) and 7 (plus or minus 2) days later using a 3 mm punch to encompass the initial biopsy sites, capturing the tissue at 3 and 7 days of healing.
Tumor necrosis factor alpha (TNFa) production by keratinocytes from patients with HIES versus healthy volunteers
Evaluate epithelial cell responses to cutaneous wounds and infections of keratinocytes and other cutaneous epithelial cells in patients with HIES or CGD and healthy volunteers.
Time frame: Throughout study
T-cell infiltration as percent of total cell infiltration in patients with CGD versus healthy volunteers.
Identify cellular mediators that contribute to the inflammatory processthrough evaluation of infiltrating cell types.
Time frame: Throughout study
Fold induction in genes related to wound healing.
Determine whether there are abnormalities in specific tissue repair pathways, such as epithelial to mesenchymal transition (EMT).
Time frame: Throughout study
Ran from Dec 2024 to primary completion in Dec 2024, 0 months.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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Granulomatous Disease, Chronic →
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