Immune Deficiency
Conditions
Keywords
immunodeficiency, IgE
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
Interventions
BIOLOGICALSalmonella typhi polysaccharide vaccine
Salmonella typhi polysaccharide vaccine
Sponsors
CSL Behring
Jeffrey Modell Foundation
University of Virginia
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Vaccination response | 4-6 weeks | IgG to Salmonella typhi will be measured, with a normal response calculated as at least a 2-fold increase in IgG titers post-vaccination |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Epsilon germline transcript production | 3 days | B cells isolated from subjects will be evaluated to determine their ability to produce Epsilon germline transcript in response to stimulation |
Countries
United States
Outcome results
None listed