Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

NCT03968211 | Completed Phase 1 FDA Drug

• 1 other identifier: 21453
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

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.

Conditions

Immune Deficiency

Keywords

immunodeficiency; IgE

Outcome Measures

Primary Outcomes (1)

• 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

  4-6 weeks

Secondary Outcomes (1)

• Epsilon germline transcript production

  3 days

Study Arms (1)

Vaccine

EXPERIMENTAL

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

Biological: Salmonella typhi polysaccharide vaccine

Interventions

Salmonella typhi polysaccharide vaccine BIOLOGICAL

Salmonella typhi polysaccharide vaccine

Also known as: Typhim Vi

Vaccine

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead
• CSL Behring: collaborator
• Jeffrey Modell Foundation: collaborator

Study Sites (1)

University of Virginia Health System

Charlottesville, Virginia, 22908, United States

Location

Related Publications (1)

• 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.

  PMID: 29453744 BACKGROUND

MeSH Terms

Conditions

Immunologic Deficiency Syndromes

Interventions

Vi polysaccharide vaccine, typhoid

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

• Larry Borish, MD

  University of Virginia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine and Microbiology

Study Record Dates

• First Submitted: May 28, 2019
• First Posted: May 30, 2019
• Study Start: July 1, 2019
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Starting 6 months after publication

Locations

US (1)