Clinical trial NCT03968211: Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
Official title: Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Immune Deficiency
Keywords: immunodeficiency
IgE
Lead sponsor: University of Virginia
Sponsor class: OTHER
Collaborators: name: CSL Behring
name: Jeffrey Modell Foundation
First posted: 2019-05-30
Enrollment: 37
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study is trying to find out if an undetectable serum immunoglobulin E (IgE) is a biomarker, or early sign of, the development of immune deficiency.

Detailed description: IgE is the antibody thought to be responsible for developing allergies. Undetectable serum IgE (an IgE below the lower limit of detection) is found in about 3% of the general population. In the past, it has been thought that having an undetectable IgE does not have any health impact, other than meaning that you are at low risk for having allergies. However, recent studies of patients with undetectable IgE have shown higher rates of infections, autoimmune disease and cancer.

Patients with an immune deficiency called common variable immunodeficiency (CVID) also have higher rates of infections, autoimmune disease and cancer. Recently, we have shown that most patients with CVID have a low/undetectable serum IgE.

This study is trying to find out if an undetectable serum IgE is a biomarker, or early sign of, the development of CVID or other antibody deficiencies

Eligibility criteria: Inclusion Criteria:

* Age 18-80
* Willingness and ability to comply with scheduled visits and study procedures
* Undetectable serum IgE (defined as \>2 IU/mL or the lower threshold of detection)
* Normal or high serum immunoglobulins (within or above laboratory reference range for IgG, IgA, and IgM)
* patients previously seen at the University of Virginia Asthma, Allergy, and Immunology clinics where undetectable serum IgE was noted
* Control subjects must have participated in study IRB#14457 (only applicable for healthy controls in epsilon germline transcript portion of the study)

Exclusion Criteria:

* The following vulnerable populations will be excluded: pregnant women, fetuses, neonates, children, prisoners, cognitively impaired, educational or economically disadvantaged, non-English speaking subjects
* Known personal history of immunodeficiency
* Known personal history of recurrent infections
* Low serum immunoglobulins (below the laboratory reference range for IgG, IgA, or IgM)
* Recent or current treatment with systemic immunosuppression within the past 30 days

Primary outcomes:
measure: Vaccination response
timeFrame: 4-6 weeks
Secondary outcomes:
measure: Epsilon germline transcript production
timeFrame: 3 days
Other outcomes:
Locations:
city: Charlottesville
country: United States
facility: University of Virginia Health System
state: Virginia
Study officials:
affiliation: University of Virginia
name: Larry Borish, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lawrence MG, Palacios-Kibler TV, Workman LJ, Schuyler AJ, Steinke JW, Payne SC, McGowan EC, Patrie J, Fuleihan RL, Sullivan KE, Lugar PL, Hernandez CL, Beakes DE, Verbsky JW, Platts-Mills TAE, Cunningham-Rundles C, Routes JM, Borish L. Low Serum IgE Is a Sensitive and Specific Marker for Common Variable Immunodeficiency (CVID). J Clin Immunol. 2018 Apr;38(3):225-233. doi: 10.1007/s10875-018-0476-0. Epub 2018 Feb 17.