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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Granuloma, Aluminum Allergy

Intervention / Treatment
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* Diagnostic Test: Aluminum
* Diagnostic Test: Tetanus toxoid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Indivicuals with vaccination granulomas controls without granulomas and no suspected contact allergies Exclusion Criteria: pregnancy, breastfeeding, recent vaccination, skin diseases

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LPT aluminium<br>Investigation of participants with aluminium allergy versus healthy controls. Aluminium in different concentrations are added to the blood samples to elicit a response | Diagnostic Test: Aluminum<br>* Different concentrations of aluminium added to the blood test in vitro<br>|
| Placebo Comparator: LPT control<br>Tetanus toxoid was added to blood samples as control substance. | Diagnostic Test: Tetanus toxoid<br>* Used as control substance<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LPT | Proliferation of T-cells | 7 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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aluminum, allergy, vaccination granuloma, SCIT, contact dermatitis, LPT