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

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.

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Key information

Conditions

Granuloma Aluminum Allergy Dermatitis Dermatitis, Contact Hemic and Lymphatic Diseases Hypersensitivity Immune System Diseases Lymphatic Diseases Lymphoproliferative Disorders Pathologic Processes Pathological Conditions, Signs and Symptoms Skin Diseases Skin Diseases, Eczematous Skin and Connective Tissue Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Allergy Research Centre, Gentofte Hospital

Hellerup, 2900, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Indivicuals with vaccination granulomas
controls without granulomas and no suspected contact allergies

Exclusion criteria

pregnancy, breastfeeding, recent vaccination, skin diseases

Treatment and study plan

Aluminum

Diagnostic Test

Different concentrations of aluminium added to the blood test in vitro

Tetanus toxoid

Diagnostic Test

Used as control substance

Primary outcomes

LPT

Time frame: 7 days

Proliferation of T-cells

Sponsors and collaborators

Lead sponsor

National Allergy Research Center, Denmark

Other

Registry information

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2023
First posted: Nov 14, 2023
Registry last updated: Nov 14, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed