Natural History, Management, and Genetics of the Hyperimmunoglobulin E Recurrent Infection Syndrome (HIES)
National Institute of Allergy and Infectious Diseases (NIAID) · with Albert Einstein College of Medicine · NCT00006150
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 1 mo–120 · All sexes
- Healthy volunteers
- Accepted
- Study type
- Observational
- Target enrollment
- 600
- US sites recruiting
- 1
- Study start
- August 10, 2000
- Record last updated
- September 28, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
The Hyper IgE Syndromes (HIES) are primary immunodeficiencies resulting in eczema and recurrent skin and lung infections. Autosomal dominant Hyper IgE syndrome (AD-HIIES; Job's syndrome) is caused by STAT3 mutations, and is a multi-system disorder with skeletal, vascular, and connective tissue manifestations. Understanding how STAT3 mutations cause these diverse clinical manifestations is critical to our complete understanding of bone metabolism, bronchiectasis, dental maturation, and atherosclerosis. Bi-allelic mutations in DOCK8 cause a combined immunodeficiency previously described as autosomal-recessive Hyper IgE syndrome. These individuals suffer from extensive viral infections as well as have a high incidence of malignancy and mortality. The pathogenesis of this disease and long-term natural history is being investigated. Therefore, we seek to enroll patients and families with a confirmed or suspected diagnosis of HIES syndrome for extensive phenotypic and genotypic study as well as disease management. Patients will be carefully examined by a multidisciplinary team and followed longitudinally. Through these studies we hope to better characterize the clinical presentation of STAT3-mutated HIES, DOCK8 deficiency and other causes of the hyper IgE phenotype, and to be able to identify further genetic etiologies, as well as understand the pathogenesis of HIES. We seek to enroll 300 patients and 300 relatives.
Conditions: Infections; Pneumonia; Immune System Diseases; STAT3 Transcription Factor; Job Syndrome
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
- INCLUSION CRITERIA:
Patients may be included in this study who:
- Were referred to the NIH with a diagnosis or a suspicion of Hyper IgE syndrome.
- Are patients referred for other immune syndromes that demonstrate some of the characteristics of HIES.
- >=1 month for affected subjects
- Aged >=2 years for unaffected subjects
- For unaffected subjects, are able to understand and have the willingness to sign a written informed consent document.
Unaffected biological relatives of HIES patients are also eligible to enroll in a separate relative cohort.
EXCLUSION CRITERIA
Coronary CTA will not be performed on any patient younger than 30 years or with contraindication to IV contrast media. This includes patients with 1) creatinine value of >1.3 mg/dL, 2) history of multiple myeloma, 3) Use of metformin-containing products less than 24 hours prior to contrast media, and 4) history of significant allergic reaction to CT contrast agents despite the use of premedication.
Subjects with a medical, psychiatric, or social condition which, in the opinion of the investigator, would place undue burden on the subject, NIH resources, or increase risk of participation, may be excluded.
Recruiting US locations
National Institutes of Health Clinical Center
Bethesda, MD 20892
Site contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · 800-411-1222 · ccopr@nih.gov
Study contacts (from the official record)
- Jean M Ulrick · (301) 221-0855 · julrick@niaid.nih.gov
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