Back to resultsUndetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
Primary Purpose
Immune Deficiency
Status
Active
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Salmonella typhi polysaccharide vaccine
Sponsored by
About this trial
This is an interventional diagnostic trial for Immune Deficiency focused on measuring immunodeficiency, IgE
Eligibility 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
Sites / Locations
- University of Virginia Health System
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Vaccine
Arm Description
Subjects who meet enrollment criteria will be administered a single intramuscular dose of the Salmonella typhi polysaccharide vaccine
Outcomes
Primary Outcome Measures
Vaccination response
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
Epsilon germline transcript production
B cells isolated from subjects will be evaluated to determine their ability to produce Epsilon germline transcript in response to stimulation
Full Information
NCT ID
NCT03968211
First Posted
May 28, 2019
Last Updated
March 6, 2023
Sponsor
University of Virginia
Collaborators
CSL Behring, Jeffrey Modell Foundation
1. Study Identification
Unique Protocol Identification Number
NCT03968211
Brief Title
Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
Official Title
Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
Study Type
Interventional
2. Study Status
Record Verification Date
March 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
July 1, 2019 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia
Collaborators
CSL Behring, Jeffrey Modell Foundation
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Immune Deficiency
Keywords
immunodeficiency, IgE
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Vaccine
Arm Type
Experimental
Arm Description
Subjects who meet enrollment criteria will be administered a single intramuscular dose of the Salmonella typhi polysaccharide vaccine
Intervention Type
Biological
Intervention Name(s)
Salmonella typhi polysaccharide vaccine
Other Intervention Name(s)
Typhim Vi
Intervention Description
Salmonella typhi polysaccharide vaccine
Primary Outcome Measure Information:
Title
Vaccination response
Description
IgG to Salmonella typhi will be measured, with a normal response calculated as at least a 2-fold increase in IgG titers post-vaccination
Time Frame
4-6 weeks
Secondary Outcome Measure Information:
Title
Epsilon germline transcript production
Description
B cells isolated from subjects will be evaluated to determine their ability to produce Epsilon germline transcript in response to stimulation
Time Frame
3 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Larry Borish, MD
Organizational Affiliation
University of Virginia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing 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
IPD Sharing Time Frame
Starting 6 months after publication
Citations:
PubMed Identifier
29453744
Citation
Lawrence MG, Palacios-Kibler TV, Workman LJ, Schuyler AJ, Steinke JW, Payne SC, McGowan EC, Patrie J, Fuleihan RL, Sullivan KE, Lugar PL, Hernandez CL, Beakes DE, Verbsky JW, Platts-Mills TAE, Cunningham-Rundles C, Routes JM, Borish L. Low Serum IgE Is a Sensitive and Specific Marker for Common Variable Immunodeficiency (CVID). J Clin Immunol. 2018 Apr;38(3):225-233. doi: 10.1007/s10875-018-0476-0. Epub 2018 Feb 17.
Results Reference
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Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency
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