Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: 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 |
Diagnostic Test: Aluminum
Different concentrations of aluminium added to the blood test in vitro
|
| Placebo Comparator: LPT control Tetanus toxoid was added to blood samples as control substance. |
Diagnostic Test: Tetanus toxoid
Used as control substance
|
Outcome Measures
Primary Outcome Measures
- LPT [7 days]
Proliferation of T-cells
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Indivicuals with vaccination granulomas
-
controls without granulomas and no suspected contact allergies
Exclusion Criteria:
- pregnancy, breastfeeding, recent vaccination, skin diseases
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | National Allergy Research Centre, Gentofte Hospital | Hellerup | Denmark | 2900 |
Sponsors and Collaborators
- National Allergy Research Center, Denmark
Investigators
- Study Director: Lars Blom, PhD, Allergy clinic, Gentofte Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- H-20073116