NCT03968211

Undetectable IgE as a Sentinel Biomarker for Humoral Immunodeficiency

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 37 (actual)
• Sponsor: University of Virginia · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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

Conditions

• Immune Deficiency

Interventions

Type	Name	Description
BIOLOGICAL	Salmonella typhi polysaccharide vaccine	Salmonella typhi polysaccharide vaccine

Timeline

• Start date: 2019-07-01
• Primary completion: 2023-12-31
• Completion: 2023-12-31
• First posted: 2019-05-30
• Last updated: 2024-03-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study