Ignite Creation Date:
2024-05-06 @ 7:47 PM
Last Modification Date:
2024-10-26 @ 3:13 PM
Study NCT ID:
NCT06130462
Status:
COMPLETED
Last Update Posted:
2023-11-14
First Post:
2023-11-08
Brief Title:
Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas
Sponsor:
National Allergy Research Center Denmark
Organization:
National Allergy Research Center Denmark
Study Overview
Official Title:
Detection of Aluminium-reactive T-lymphocytes in Patients With Vaccination Granulomas
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None