The α-gal Syndrome - Investigating Immune Reactions to Tick Bites

NCT07177729 | Recruiting

• 1 other identifier: 20241006-ImmunoGal
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Alpha-Gal Syndrome

Keywords

Tick-borne diseases; Tick bites; alpha-Gal syndrome; immuno-phenotyping

Outcome Measures

Primary Outcomes (2)

• 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.

  2 years after the enrollment of the last study participant

• 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

  From enrollment until 6 months after the last inclusion

Study Arms (2)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Luxembourg Institute of Health: lead
• Luxembourg National Research Fund (FNR): collaborator
• Centre Hospitalier du Luxembourg: collaborator

Study Sites (2)

LCTR

Luxembourg, Luxembourg

RECRUITING

Centre Hospitalier du Luxembourg (CHL)

Strassen, Luxembourg

ACTIVE NOT RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood for serum and PBMC isolation

MeSH Terms

Conditions

red meat allergy; Tick-Borne Diseases; Tick Bites

Condition Hierarchy (Ancestors)

Vector Borne Diseases; Infections; Bites and Stings; Poisoning; Chemically-Induced Disorders; Wounds and Injuries

Study Officials

• Christiane Hilger, Dr

  Luxembourg Institute of Health

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Christiane Hilger, Dr

CONTACT

+352 26970258; christiane.hilger@lih.lu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 2, 2025
• First Posted: September 17, 2025
• Study Start: July 1, 2025
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: March 30, 2026

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

LU (2)