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Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

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ClinicalTrials.gov Identifier: NCT03968211
Recruitment Status : Recruiting
First Posted : May 30, 2019
Last Update Posted : February 18, 2020
Sponsor:
Collaborators:
CSL Behring
Jeffrey Modell Foundation
Information provided by (Responsible Party):
Larry Borish, MD, University of Virginia

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.

Condition or disease Intervention/treatment Phase
Immune Deficiency Biological: Salmonella typhi polysaccharide vaccine Phase 1

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 45 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
Actual Study Start Date : July 1, 2019
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : December 31, 2024

Arm Intervention/treatment
Experimental: Vaccine
Subjects who meet enrollment criteria will be administered a single intramuscular dose of the Salmonella typhi polysaccharide vaccine
Biological: Salmonella typhi polysaccharide vaccine
Salmonella typhi polysaccharide vaccine
Other Name: Typhim Vi




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03968211


Contacts
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Contact: Monica G Lawrence, MD 434-924-5917 ml4nz@virginia.edu
Contact: Kristin Wavell 434-924-6874 kww7d@virginia.edu

Locations
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United States, Virginia
University of Virginia Health System Recruiting
Charlottesville, Virginia, United States, 22908
Contact: Kristin Wavell    434-924-6874    kww7d@virginia.edu   
Principal Investigator: Larry Borish, MD         
Sub-Investigator: Monica G Lawrence, MD         
Sponsors and Collaborators
University of Virginia
CSL Behring
Jeffrey Modell Foundation
Investigators
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Principal Investigator: Larry Borish, MD University of Virginia
Publications:
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Responsible Party: Larry Borish, MD, Professor of Medicine and Microbiology, University of Virginia
ClinicalTrials.gov Identifier: NCT03968211    
Other Study ID Numbers: 21453
First Posted: May 30, 2019    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: De-identified IPD that underlie results in a publication will be made available upon request of another researcher or if required by the publisher
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
Time Frame: Starting 6 months after publication

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Keywords provided by Larry Borish, MD, University of Virginia:
immunodeficiency
IgE
Additional relevant MeSH terms:
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Immunologic Deficiency Syndromes
Immune System Diseases