NCT06130462

Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: National Allergy Research Center, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

Vaccines and subcutanoeus immunotherapy vaccines often contains aluminium, and may induce itching granulomas at the injection site. This is usually diagnosed by patch testing. Another way of detecting metal allergy is by investigation metal-specific cells in the blood. We include participants both with and without granulomas, all have a blood test taken where we investigate if any participants have aluminium-specific cirkulation cells, and whether we can detect a difference between participants with and without granulomas.

Detailed description

Aluminium-adsorbed vaccines and subcutaneous immunotherapy may induce vaccination granulomas at injection site. Most children have concormitant aluminium contact allergy diagnosed by path testing, but in adults the allergy can rarely be detected by patch tests. An alternative to patch testing is the blood in vitro lymphocyte proliferation test (LPT), which we investigated using a well-established LPT protocol. This has previously been shown to detect and characterize metal-specific cells and was used to detect circulating aluminium-specific proliferation. The LPT test is based on a single blood sample and has mostly been used to detect drug hypersensitivity. Still, its role in detecting metal allergy is expanding, with recent studies suggesting using the test as a supplement to the patch test when only a few allergens are to be investigated.

Conditions

• Granuloma
• Aluminum Allergy

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Aluminum	Different concentrations of aluminium added to the blood test in vitro
DIAGNOSTIC_TEST	Tetanus toxoid	Used as control substance

Timeline

• Start date: 2022-09-13
• Primary completion: 2022-10-24
• Completion: 2023-02-20
• First posted: 2023-11-14
• Last updated: 2023-11-14

Locations

1 site across 1 country: Denmark