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临床试验/NCT07177729
NCT07177729招募中不适用

The α-gal Syndrome - Investigating Immune Reactions to Tick Bites Leading to Inflammation and Allergic Sensitization

Luxembourg Institute of Health2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年7月1日最近更新:

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
2
主要终点
Tick and tick-borne pathogen surveillance

研究概览

简要总结

Tick bites can transmit pathogens, but they can also induce a food allergy to mammalian meat. The goal of this clinical trial is to follow immune response and antibody build-up in individuals bitten by a tick. Participants are invited to enroll within 48 hours after the tick removal and donate some blood. The tick is also collected and analysed. Researchers will then try to answer the following questions:

  • Was the tick infected with parasites?
  • Did the participant make antibodies against tick proteins or tick-borne parasites?
  • Did the participant develop IgE antibodies against the alpha-Gal sugar? The alpha-Gal sugar is present on mammalian meat, and ticks can transmit the alpha-Gal sugar to the host during their blood meal. Humans recognize the alpha-Gal sugar as foreign and some individuals will build IgE antibodies in response. These IgE antibodies against alpha-Gal can lead to a food allergy to red meat, also known as alpha-Gal syndrome.

Researchers will compare a group of participants that develop IgE against the alpha-Gal sugar with participants that will not. They want to find out if there are specific immune features that differentiate the 2 groups.

Participants will:

  • Enroll after a recent tick bite within 48 hours after tick removal: they will be asked to donate some blood and fill out a questionnaire.
  • Visit the clinic 4 to 6 weeks later for a follow-up sample and questionnaire.
  • Visit the clinic 3 months after the tick bite for allergy tests if they have been selected for this 3rd visit.

详细描述

Ticks bearing pathogens can transmit infectious diseases such as Lyme borreliosis, tick-borne encephalitis and others. Recently, a non-infectious human disease, namely the alpha-gal syndrome (AGS), was shown to be of tick origin. AGS, characterized by the presence of IgE antibodies directed against the carbohydrate galactose-α-1,3-galactose (alpha-gal or α-gal) is also known as 'red meat allergy'. Unlike the more 'classical' food allergies, symptoms are delayed and may appear several hours after ingestion of mammalian meat or dairy products, often hampering a timely clinical diagnosis.

Individuals with occupational or recreational outdoor activities often experience frequent tick bites and they have a higher risk of developing AGS. There are still many questions regarding the etiology and the development of the disease. Not every tick bite will lead to sensitization and it is presently unclear how the human immune system reacts to tick bites and why the initial events after a tick bite will either lead to a short-lived natural immune defense or shift the immune response to an uncontrolled Th2 response which potentially leads to allergic disease. Tick bites also bear the risk of pathogen transmission, and there is a clear need for monitoring tick bites for public health purposes.

The present study will investigate early peripheral immune responses in individuals bitten by a tick. The investigators hypothesize that the pathway to allergic sensitization to α-gal is already predictable from the peripheral immune response early after a tick bite and that an adequate protective defense against ticks can be distinguished from an allergic inflammatory response by discrete marker signatures shortly after the tick bite. Additionally, the investigators will collect population-based tick surveillance data which will be an important contribution to public health. The advertising of the study for recruitment purposes will be combined with information on tick avoidance and monitoring in case of a bite, thus contributing to public awareness and education.

The objectives of the study are:

i) To determine peripheral inflammatory protein and cellular as well as intracellular signatures leading to either a normal and self-limited human immune defense or to allergic sensitization; ii) To generate surveillance data on tick-related diseases (pathogens/allergy) in individuals experiencing a tick bite.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Individuals aged ≥ 18 years, Male and Female.
  • Experience of a tick bite: the tick has been removed less than 48 hours ago, or the tick is still attached to the skin and can be removed on site by the study nurse.
  • Tick available for analysis.
  • Informed consent signed.

排除标准

  • Individuals < 18 years of age, Male or Female.
  • Individuals with an acute viral/bacterial inflammation.
  • Individuals with an immune deficiency or under immunosuppressive treatments.
  • Individuals in receipt with immunotherapy with omalizumab.
  • Individuals with neurological diseases / impaired cognitive disorder.

研究组 & 干预措施

a-Gal sensitized participants

Following the second visit 4 to 6 weeks after the tick bite, participants with specific alpha-Gal IgE levels above 0.1 kU/L are assigned to this group of a-Gal sensitized participants.

a-Gal non-sensitized participants

Following the second visit 4 to 6 weeks after the tick bite, participants with specific alpha-Gal IgE levels below 0.1 kU/L are assigned to this group of a-Gal non-sensitized participants.

结局指标

主要结局

Tick and tick-borne pathogen surveillance

时间窗: From enrollment until 6 months after the last inclusion

The identification of the tick species and search for pathogens will generate crucial data that are important for tick surveillance in Luxembourg

Determination of immune signatures leading to allergic sensitization after a tick bite

时间窗: 2 years after the enrollment of the last study participant

We expect to determine immune signatures predicting a reaction leading to allergic sensitization and answer fundamental questions on pathways leading from a tick bite to a Th2 immune response.

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Christiane Hilger

Dr

Luxembourg Institute of Health

研究点 (2)

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