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

Granuloma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06130462
• Other study ID #: H-20073116
• Status: Completed
• Phase: N/A
• Start date: September 13, 2022
• Est. completion date: February 20, 2023

Study information

• Verified date: November 2023
• Source: National Allergy Research Center, Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: February 20, 2023
• Est. primary completion date: October 24, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Indivicuals with vaccination granulomas

• controls without granulomas and no suspected contact allergies

Exclusion Criteria:

• pregnancy, breastfeeding, recent vaccination, skin diseases

Related Conditions & MeSH terms

• Aluminum Allergy
• Granuloma

Intervention

Diagnostic Test:
• Aluminum
Different concentrations of aluminium added to the blood test in vitro
• Tetanus toxoid
Used as control substance

Locations

Country	Name	City	State
Denmark	National Allergy Research Centre, Gentofte Hospital	Hellerup

Sponsors (1)

Lead Sponsor	Collaborator
National Allergy Research Center, Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LPT	Proliferation of T-cells	7 days