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OpenTrials
Completed

NCT Number: NCT03968211

Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

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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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

About this study

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

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salmonella typhi polysaccharide vaccine

Biological

Salmonella typhi polysaccharide vaccine

Other names: Typhim Vi

Primary outcomes

  1. Vaccination response

    Time frame: 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 outcomes

  1. Epsilon germline transcript production

    Time frame: 3 days

    B cells isolated from subjects will be evaluated to determine their ability to produce Epsilon germline transcript in response to stimulation

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • CSL Behring
  • Jeffrey Modell Foundation

Registry information

Important dates

Study start
2019
Primary completion
2023
Study completion
2023
First posted
May 30, 2019
Registry last updated
Mar 29, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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