Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

Immune Deficiency Clinical Trial

Official title:

Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03968211
• Other study ID #: 21453
• Status: Completed
• Phase: Phase 1
• Start date: July 1, 2019
• Est. completion date: December 31, 2023

Study information

• Verified date: March 2024
• Source: University of Virginia
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: December 31, 2023
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Immune Deficiency
• Immunologic Deficiency Syndromes

Intervention

Biological:
• Salmonella typhi polysaccharide vaccine
Salmonella typhi polysaccharide vaccine

Locations

Country	Name	City	State
United States	University of Virginia Health System	Charlottesville	Virginia

Sponsors (3)

Lead Sponsor	Collaborator
University of Virginia	CSL Behring, Jeffrey Modell Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Vaccination response	IgG to Salmonella typhi will be measured, with a normal response calculated as at least a 2-fold increase in IgG titers post-vaccination	4-6 weeks
Secondary	Epsilon germline transcript production	B cells isolated from subjects will be evaluated to determine their ability to produce Epsilon germline transcript in response to stimulation	3 days