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

NCT ID: NCT06130462

Last Updated: 2023-11-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-09-13

Study Completion Date

2023-02-20

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.

Conditions

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Granuloma Aluminum Allergy

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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LPT aluminium

Investigation of participants with aluminium allergy versus healthy controls. Aluminium in different concentrations are added to the blood samples to elicit a response

Group Type ACTIVE_COMPARATOR

Aluminum

Intervention Type DIAGNOSTIC_TEST

Different concentrations of aluminium added to the blood test in vitro

LPT control

Tetanus toxoid was added to blood samples as control substance.

Group Type PLACEBO_COMPARATOR

Tetanus toxoid

Intervention Type DIAGNOSTIC_TEST

Used as control substance

Interventions

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Aluminum

Different concentrations of aluminium added to the blood test in vitro

Intervention Type DIAGNOSTIC_TEST

Tetanus toxoid

Used as control substance

Intervention Type DIAGNOSTIC_TEST

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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National Allergy Research Center, Denmark

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Lars Blom, PhD

Role: STUDY_DIRECTOR

Allergy clinic, Gentofte Hospital

Locations

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National Allergy Research Centre, Gentofte Hospital

Hellerup, , Denmark

Site Status

Countries

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Denmark

Other Identifiers

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H-20073116

Identifier Type: -

Identifier Source: org_study_id

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