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临床试验/NCT06130462
NCT06130462已完成不适用

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

National Allergy Research Center, Denmark2 个研究点 分布在 1 个国家目标入组 16 人开始时间: 2022年9月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
16
试验地点
2
主要终点
LPT

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

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

排除标准

  • pregnancy, breastfeeding, recent vaccination, skin diseases

结局指标

主要结局

LPT

时间窗: 7 days

Proliferation of T-cells

次要结局

未报告次要终点

研究者

发起方
National Allergy Research Center, Denmark
申办方类型
Other
责任方
Sponsor

研究点 (2)

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