Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

37 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2023-12-31

Brief Summary

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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.

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Detailed Description

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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

Conditions

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Immune Deficiency

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Vaccine

Subjects who meet enrollment criteria will be administered a single intramuscular dose of the Salmonella typhi polysaccharide vaccine

Group Type EXPERIMENTAL

Salmonella typhi polysaccharide vaccine

Intervention Type BIOLOGICAL

Salmonella typhi polysaccharide vaccine

Interventions

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Salmonella typhi polysaccharide vaccine

Intervention Type BIOLOGICAL

Other Intervention Names

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Typhim Vi

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes