The α-gal Syndrome - Investigating Immune Reactions to Tick Bites
ConditionAlpha-Gal Syndrome
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorLuxembourg Institute of Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Adult population having experienced a recent tick bite and volunteering to visit the study clinic for blood donation at 2 time-points, respectively 3 time-points for a selected subgroup.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
100 Participants
are grouped into 2 trial groupsGroup A: a-Gal sensitized participants
Group B: a-Gal non-sensitized participants
Trial outcomes
Primary outcomes
1
Determination of immune signatures leading to allergic sensitization after a tick bite
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.
Time frame
2 years after the enrollment of the last study participant2
Tick and tick-borne pathogen surveillance
The identification of the tick species and search for pathogens will generate crucial data that are important for tick surveillance in Luxembourg
Time frame
From enrollment until 6 months after the last inclusionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Luxembourg Institute of Health
Lead sponsor
Centre Hospitalier du Luxembourg
Collaborator
Luxembourg National Research Fund
Collaborator
Source ClinicalTrials.gov