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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06130462
Enrollment
16
Registered
2023-11-14
Start date
2022-09-13
Completion date
2023-02-20
Last updated
2023-11-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Granuloma, Aluminum Allergy

Keywords

aluminum, allergy, contact dermatitis, vaccination granuloma, LPT, SCIT

Brief 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.

Interventions

DIAGNOSTIC_TESTAluminum

Different concentrations of aluminium added to the blood test in vitro

DIAGNOSTIC_TESTTetanus toxoid

Used as control substance

Sponsors

National Allergy Research Center, Denmark
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

Inclusion criteria

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

Exclusion criteria

* pregnancy, breastfeeding, recent vaccination, skin diseases

Design outcomes

Primary

MeasureTime frameDescription
LPT7 daysProliferation of T-cells

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026