Hymenoptera Venom AllergyNCT07721233
Virtual-reality Induced Immune Modulation in Allergic Patients
A study testing Allergen-related immersive virtual reality exposure in people with Hymenoptera Venom Allergy, run by University of Geneva, Switzerland.
Trial summary
This study investigates whether immersive virtual reality (VR) exposure to allergen-related stimuli can modulate behavioural, neurophysiological, psychophysiological, and immune responses in adults with bee or wasp venom allergy. The study consists of two parts. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Hymenoptera Venom Allergy
- What is being tested?
- Allergen-related immersive virtual reality exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 81 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to Oct 2030
- Phase
- Interventional
- 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
Who may be able to join
- Age 18 years or older.
- Able to understand the participant information and provide written informed consent.
- Willing and able to comply with all study procedures.
- Part 1 - Healthy volunteers
- No known bee or wasp venom allergy.
- No current allergen immunotherapy or monoclonal antibody treatment.
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- No known active allergic, autoimmune, inflammatory, or immunodeficiency disorder requiring systemic treatment.
- Part 1 - Participants with bee or wasp venom allergy
- Documented bee and/or wasp venom allergy based on medical history and/or routine allergy work-up.
- No ongoing venom immunotherapy at the time of inclusion in Part 1.
- No current monoclonal antibody treatment or systemic immunosuppressive treatment at the time of testing.
- Part 2 - Participants undergoing venom immunotherapy
- Documented bee and/or wasp venom allergy based on medical history and/or routine allergy work-up.
- Planned initiation of or ongoing treatment with standard-of-care venom immunotherapy.
Who cannot join
- Absence of written informed consent.
- Inability to understand the study information or provide informed consent.
- Age younger than 18 years.
- Current systemic immunosuppressive therapy.
- Current monoclonal antibody treatment for an allergic, autoimmune, or inflammatory disease at the time of testing.
- Ongoing allergen immunotherapy for allergies other than bee or wasp venom allergy.
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- Leukocyte count below 3.5 G/L.
- Hemoglobin below approximately 120 g/L in women or below approximately 130 g/L in men.
- Bee or wasp sting reaction within the previous 2 months.
- Intolerance to virtual reality, as assessed during a preliminary interview
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This study investigates whether immersive virtual reality (VR) exposure to allergen-related stimuli can modulate behavioural, neurophysiological, psychophysiological, and immune responses in adults with bee or wasp venom allergy.
The study consists of two parts. In Part 1, adults with documented bee or wasp venom allergy and healthy volunteers will undergo immersive VR exposure in a realistic picnic environment. All participants will first be exposed to a control condition involving virtual flies. They will then be randomly assigned to exposure to either virtual bees or wasps or a control condition involving virtual flies. During the VR sessions, behavioural responses, heart rate and heart-rate variability, skin conductance, pupil dilation, temperature, and electroencephalographic activity will be recorded. Blood samples will be collected before and after VR exposure to assess changes in basophil activation and other immunological markers.
Read more
In Part 2, patients receiving standard-of-care venom immunotherapy will be followed longitudinally. Blood samples will be collected before and during treatment to characterize immunological changes associated with venom desensitization. After approximately six months of venom immunotherapy, participants will undergo a further VR session involving either virtual bees or wasps or virtual flies. Behavioural, psychophysiological, neurophysiological, and immunological assessments will be repeated to determine whether venom immunotherapy reduces responses to virtual allergen-related stimuli.
The primary outcome is the change in basophil activation, measured as the percentage of CD63-positive circulating basophils. Secondary outcomes include changes in circulating type 2 innate lymphoid cells and regulatory T cells, serum IL-13 and tryptase concentrations, reaction times, cardiovascular and autonomic responses, pupil dilation, skin temperature, and electroencephalographic responses.
The study does not involve exposure to real insects or venom as part of the investigational VR procedure. Its aim is to improve understanding of brain-immune interactions in allergy and to provide preliminary evidence for the potential future use of VR-based approaches alongside conventional allergy treatment.
- Conditions
- Hymenoptera Venom Allergy
- Being tested
- Allergen-related immersive virtual reality exposure, Control immersive virtual reality exposure
- Keywords
- Virtual Reality, Neuroimmune Interaction, Immune Modulation, Basophil Activation, Venom Immunotherapy, Bee Venom, Wasp Venom
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allergen-related immersive virtual reality exposureBehavioural
Participants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual bees or wasps progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief stimulus is delivered to simulate a sting.
Control immersive virtual reality exposureBehavioural
Participants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual flies progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief synchronized stimulus is delivered to simulate touch or tickling. In Part 1, this intervention is administered to all participants as the initial baseline exposure and is repeated in participants assigned to the control condition.
| Study group | Role | What they receive |
|---|---|---|
| Part 1: Allergen-related VR exposure | Experimental | Not described Receives: Behavioral: Allergen-related immersive virtual reality exposure; Behavioral: Control immersive virtual reality exposure |
| Part 1: Control VR exposure | Sham comparator | Not described Receives: Behavioral: Control immersive virtual reality exposure |
| Part 2: Allergen-related VR exposure during VIT | Experimental | Not described Receives: Behavioral: Allergen-related immersive virtual reality exposure |
| Part 2: Control VR exposure during VIT | Sham comparator | Not described Receives: Behavioral: Control immersive virtual reality exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Percentage of CD63-Positive Circulating Basophils Following Virtual-Reality Exposure in Part 1
Measured: T0, 10 minutes after the initial fly exposure, to T2, 40 minutes after the second VR exposure; same study day
Change in Percentage of CD63-Positive Circulating Basophils During Venom Immunotherapy and Subsequent Virtual-Reality Exposure in Part 2
Measured: Before initiation of venom immunotherapy at T0 to 40 minutes after VR exposure at approximately month 7 at T5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completionOct 2030 (estimated)
- Study completionOct 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hymenoptera Venom AllergyStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 81 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Geneva, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Peter Jandus, University of Geneva, Switzerland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07721233
- Sponsor's protocol ID
- UNIGE-VR-ALLERGY-2026-01
- Status last verified
- Jul 2026
- First submitted
- 17 Jul 2026
- Last updated
- 23 Jul 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The protocol states that raw individual-level results will not be shared with third parties and that study results will be presented only in aggregated, non-identifiable form. This does not prevent publication of aggregate results or deposition of summary datasets that contain no participant-level information.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Virtual-reality Induced Immune Modulation in Allergic Patients
- ClinicalTrials.gov ID
- NCT07721233
- Acronym / sponsor ID
- UNIGE-VR-ALLERGY-2026-01
- Conditions
- Hymenoptera Venom Allergy
- Keywords
- Virtual Reality, Neuroimmune Interaction, Immune Modulation, Basophil Activation, Venom Immunotherapy, Bee Venom, Wasp Venom
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 81 participants (estimated)
- Lead sponsor
- University of Geneva, SwitzerlandUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- Oct 2030 (estimated)
- Study completion
- Oct 2030 (estimated)
- First posted
- 23 Jul 2026 (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.
This study investigates whether immersive virtual reality (VR) exposure to allergen-related stimuli can modulate behavioural, neurophysiological, psychophysiological, and immune responses in adults with bee or wasp venom allergy.
The study consists of two parts. In Part 1, adults with documented bee or wasp venom allergy and healthy volunteers will undergo immersive VR exposure in a realistic picnic environment. All participants will first be exposed to a control condition involving virtual flies. They will then be randomly assigned to exposure to either virtual bees or wasps or a control condition involving virtual flies. During the VR sessions, behavioural responses, heart rate and heart-rate variability, skin conductance, pupil dilation, temperature, and electroencephalographic activity will be recorded. Blood samples will be collected before and after VR exposure to assess changes in basophil activation and other immunological markers.
In Part 2, patients receiving standard-of-care venom immunotherapy will be followed longitudinally. Blood samples will be collected before and during treatment to characterize immunological changes associated with venom desensitization. After approximately six months of venom immunotherapy, participants will undergo a further VR session involving either virtual bees or wasps or virtual flies. Behavioural, psychophysiological, neurophysiological, and immunological assessments will be repeated to determine whether venom immunotherapy reduces responses to virtual allergen-related stimuli.
The primary outcome is the change in basophil activation, measured as the percentage of CD63-positive circulating basophils. Secondary outcomes include changes in circulating type 2 innate lymphoid cells and regulatory T cells, serum IL-13 and tryptase concentrations, reaction times, cardiovascular and autonomic responses, pupil dilation, skin temperature, and electroencephalographic responses.
The study does not involve exposure to real insects or venom as part of the investigational VR procedure. Its aim is to improve understanding of brain-immune interactions in allergy and to provide preliminary evidence for the potential future use of VR-based approaches alongside conventional allergy treatment.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Part 1: Allergen-related VR exposure | Experimental | Behavioral: Allergen-related immersive virtual reality exposure, Behavioral: Control immersive virtual reality exposure |
| Part 1: Control VR exposure | Sham comparator | Behavioral: Control immersive virtual reality exposure |
| Part 2: Allergen-related VR exposure during VIT | Experimental | Behavioral: Allergen-related immersive virtual reality exposure |
| Part 2: Control VR exposure during VIT | Sham comparator | Behavioral: Control immersive virtual reality exposure |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Age 18 years or older.
- Able to understand the participant information and provide written informed consent.
- Willing and able to comply with all study procedures.
- Part 1 - Healthy volunteers
- No known bee or wasp venom allergy.
Key exclusion criteria (10 listed)
- Absence of written informed consent.
- Inability to understand the study information or provide informed consent.
- Age younger than 18 years.
- Current systemic immunosuppressive therapy.
- Current monoclonal antibody treatment for an allergic, autoimmune, or inflammatory disease at the time of testing.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allergen-related immersive virtual reality exposureParticipants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual bees or wasps progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief stimulus is delivered to simulate a sting. | Behavioural | Part 1: Allergen-related VR exposure, Part 2: Allergen-related VR exposure during VIT |
| Control immersive virtual reality exposureParticipants undergo an immersive virtual reality session in a realistic multisensory environment. Virtual flies progressively approach the participant and ultimately land on the participant's hand. Visual, auditory, and haptic stimuli are presented, and a brief synchronized stimulus is delivered to simulate touch or tickling. In Part 1, this intervention is administered to all participants as the initial baseline exposure and is repeated in participants assigned to the control condition. | Behavioural | Part 1: Allergen-related VR exposure, Part 1: Control VR exposure, Part 2: Control VR exposure during VIT |
Primary outcome
Change in Percentage of CD63-Positive Circulating Basophils Following Virtual-Reality Exposure in Part 1
Time frame: T0, 10 minutes after the initial fly exposure, to T2, 40 minutes after the second VR exposure; same study day
Change in Percentage of CD63-Positive Circulating Basophils During Venom Immunotherapy and Subsequent Virtual-Reality Exposure in Part 2
Time frame: Before initiation of venom immunotherapy at T0 to 40 minutes after VR exposure at approximately month 7 at T5
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 23 Jul 2026.
- Individual participant dataSharing planned: No. The protocol states that raw individual-level results will not be shared with third parties and that study results will be presented only in aggregated, non-identifiable form. This does not prevent publication of aggregate results or deposition of summary datasets that contain no participant-level information.
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.
Questions about this trial
What is this clinical trial studying?
A study testing Allergen-related immersive virtual reality exposure in people with Hymenoptera Venom Allergy, run by University of Geneva, Switzerland.
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 14 inclusion and 10 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: opening soon, as of the sponsor's last update on 23 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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 Peter Jandus (+41 22 372 93 82, peter.jandus@hug.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Percentage of CD63-Positive Circulating Basophils Following Virtual-Reality Exposure in Part 1 (time frame: T0, 10 minutes after the initial fly exposure, to T2, 40 minutes after the second VR exposure; same study day). 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 23 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.