Alpha-Gal SyndromeImmunoGalNCT07177729
The α-gal Syndrome - Investigating Immune Reactions to Tick Bites
An observational study of Alpha-Gal Syndrome, run by Luxembourg Institute of Health at 2 sites in Luxembourg.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Alpha-Gal Syndrome
- How many people
- 100 participants
- Where
- 2 sitesLuxembourg
- Study dates
- 1 Jul 2025to Feb 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Luxembourg2 sites, 1 recruiting
- Recruiting
LCTR
Luxembourg
Ali Znati, +352 26970-811, Ali.Znati@lih.lu
Alessia Pochesci, Dr med
- Active, not recruiting
Centre Hospitalier du Luxembourg (CHL)
Strassen
About this study
Official title: The α-gal Syndrome - Investigating Immune Reactions to Tick Bites Leading to Inflammation and Allergic Sensitization
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.
Read more
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.
Read the detailed description
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:
- 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.
In order to achieve these objectives, the researchers will perform a deep immune analysis of blood samples collected upon a tick bite by using multi-omics and high-resolution techniques. They will longitudinally follow 100 study participants for several weeks and determine their serological status. Blood will be collected at day 1, then 4 to 6 weeks after the bite. For 2 subgroups of participants, selected for their sensitization to a-Gal and a control group without a-Gal sensitization, a 3rd visit is planned 8 to 12 weeks after the bite for clinical assessment. A questionnaire on the 2 first visits will collect data regarding tick bite history, current tick bite, current health status, allergic disease, diet for meat and dairy products.
The tick responsible for the bite will also be collected. The species will be identified and analysed for tick-borne pathogens by PCR. The identification of the tick species and search for tick-borne pathogens will generate crucial data that are important for tick and tick-related disease surveillance in Luxembourg.
- Conditions
- Alpha-Gal Syndrome
- Keywords
- Tick-borne diseases, Tick bites, alpha-Gal syndrome, immuno-phenotyping
- Medical subject headings
- red meat allergy, Tick-Borne Diseases, Tick Bites
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
Measured: From enrollment until 6 months after the last inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2025
- Study start1 Jul 2025
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Alpha-Gal SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Luxembourg Institute of Health
- Sponsor type
- Other government
- Collaborators
- Centre Hospitalier du Luxembourg, Luxembourg National Research Fund
- Responsible party
- Sponsor
- Investigators
- Christiane Hilger, Dr, Principal investigator, Luxembourg Institute of Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07177729
- Sponsor's protocol ID
- 20241006-ImmunoGal
- Acronym
- ImmunoGal
- Status last verified
- Sep 2025
- First submitted
- 2 Sep 2025
- Last updated
- 30 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The α-gal Syndrome - Investigating Immune Reactions to Tick Bites Leading to Inflammation and Allergic Sensitization
- ClinicalTrials.gov ID
- NCT07177729
- Acronym / sponsor ID
- ImmunoGal / 20241006-ImmunoGal
- Conditions
- Alpha-Gal Syndrome
- Keywords
- Tick-borne diseases, Tick bites, alpha-Gal syndrome, immuno-phenotyping
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Luxembourg Institute of HealthOther government
- Collaborators
- Centre Hospitalier du Luxembourg, Luxembourg National Research Fund
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 17 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- 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.
In order to achieve these objectives, the researchers will perform a deep immune analysis of blood samples collected upon a tick bite by using multi-omics and high-resolution techniques. They will longitudinally follow 100 study participants for several weeks and determine their serological status. Blood will be collected at day 1, then 4 to 6 weeks after the bite. For 2 subgroups of participants, selected for their sensitization to a-Gal and a control group without a-Gal sensitization, a 3rd visit is planned 8 to 12 weeks after the bite for clinical assessment. A questionnaire on the 2 first visits will collect data regarding tick bite history, current tick bite, current health status, allergic disease, diet for meat and dairy products.
The tick responsible for the bite will also be collected. The species will be identified and analysed for tick-borne pathogens by PCR. The identification of the tick species and search for tick-borne pathogens will generate crucial data that are important for tick and tick-related disease surveillance in Luxembourg.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Determination of immune signatures leading to allergic sensitization after a tick bite
Time frame: 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.
Tick and tick-borne pathogen surveillance
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Mar 2026.
- Individual participant dataSharing planned: No
Related trials for Alpha-Gal Syndrome
RecruitingPhase 2
Beginning to Assess an Appropriate CONtrol for Oral Food Challenges in Alpha-Gal Syndrome (CoFAR-13) - BeACON4AG
Alpha-Gal Syndrome, Allergy
RecruitingObservational study
Screening Study for KIT D816V Mutated Mast Cell Disease in Select Populations
Clonal Mast Cell Disease, KIT D816V Mutation
Not yet recruitingPhase 2
Mast Cell Treatment in Post-tick Bite Illness (PTBI)
Post-tick Bite Illness, Mast Cell Stabilizer
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Christiane Hilger, Dr principal investigator
Luxembourg Institute of Health
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Alpha-Gal Syndrome, run by Luxembourg Institute of Health at 2 sites in Luxembourg.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 30 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Luxembourg. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christiane Hilger, Dr (+352 26970258, christiane.hilger@lih.lu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of immune signatures leading to allergic sensitization after a tick bite (time frame: 2 years after the enrollment of the last study participant). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Mar 2026.