Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    University of Virginia
Updated on 24 May 2022
serum ige
immune globulin
Accepts healthy volunteers


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.


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

Condition Immune Deficiency
Treatment Salmonella typhi polysaccharide vaccine
Clinical Study IdentifierNCT03968211
SponsorUniversity of Virginia
Last Modified on24 May 2022


Yes No Not Sure

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
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How to participate?

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What happens next?
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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