Allergy, Insect VenomVenox-23NCT06790368
Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
An observational study of Allergy, Insect Venom and Allergy Insect Stinging, run by Inmunotek S.L. at 3 sites in Spain.
Trial summary
Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively. Read more about this study
- Who is it for?
- Ages 14 years and older
- Conditions the study is for
- Allergy, Insect Venom, Allergy Insect Stinging, Insect Sting Allergy
- What is being tested?
- VENOX
- Type of treatment
- Vaccines
- How many people
- 80 participants
- Where
- 3 sitesSpain
- Study dates
- 1 Jan 2025to 1 Jun 2026
- 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 14 years and older
- All sexes
- Child, Adult, Older adult
Study population: Participants of both gender aged 14 years or more diagnosed of allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive ITVH according to standard clinical practice.
Who may be able to join
- The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.
- Participants of both sexes aged 14 years or more.
- Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.
- Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.
Who cannot join
- Pregnant or breastfeeding women.
- Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.
- Participants who do not agree to participate and/or do not sign the informed consent form.
- Participants who do not comply with medical indications or do not cooperate with immunotherapy treatment.
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Spain3 sites, 3 recruiting
- Recruiting
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, 28922
Teresa Alfaya, +34 916219400, teresa.alfaya@salud.madrid.org
Jesús Macías Iglesias
- Recruiting
Hospital Reina Sofía
Córdoba
M.ª Berta Ruiz León, Dr, rulebe@gmail.com
- Recruiting
Hospital Universitario de Guadalajara
Guadalajara, 19002
Arantza Vega Castro, +34 949209200, arantza.vega@gmail.com
Juan María Beitia Mazuecos
About this study
Official title: Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.
Read the detailed description
Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.
- Being tested
- VENOX
- Keywords
- Allergy, Immunotherapy, Apis mellifera, Vespula sp, controlled sting
- Medical subject headings
- Venom Hypersensitivity, Hypersensitivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VENOXBiological
Treatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.
| Study group | Role | What they receive |
|---|---|---|
| Patients allergic to hymenoptera venom | Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX inmunotherapy (ATC code: V01AA07) Receives: Biological: VENOX |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).
Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).
Measured: 12 months
Secondary outcomes (3)
Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural stings during the 1-year follow-up.
Registration of allergic reactions, spontaneous natural stings and a controlled sting test in participants sensitised to hymenoptera venom (Apis mellifera and/or Vespula spp.).
Measured: 12 months
Immunological parameters of the participants after 12 months of treatment.
Immunological study: total IgE, specific IgE, IgG4, IgG1 (total extract and molecular components of Vespula spp. and Apis mellifera). The immunological analysis will be performed according to the usual clinical practice of the site and the serum samples will be stored for the complete analysis in the facilities of the sponsor, using the ALEX technique.
Measured: 12 months
SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.
The quality of life questionnaire consists of 14 questions, the first nine questions are mandatory. The score for each question is inverse to the order of the answer, i.e. the first answer scores 7 and the seventh 1. The score shall be obtained by adding up all the questions answered and dividing by the total number of questions answered. .The total score goes from 1 to 7, with 1 indicating the worst quality of life and 7 the best.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2025
- Study start1 Jan 2025
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Allergy, Insect VenomStudies of the same condition, open and under way.
- More trials run by Inmunotek S.L.The sponsor's other registered studies.
- 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
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arantza Vega Castro, Principal investigator, University of Guadalajara
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06790368
- Sponsor's protocol ID
- ITK-VENOX-2023-01
- Acronym
- Venox-23
- Status last verified
- Apr 2025
- First submitted
- 16 Sep 2024
- Last updated
- 1 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Krishna MT, Ewan PW, Diwakar L, Durham SR, Frew AJ, Leech SC, Nasser SM; British Society for Allergy and Clinical Immunology. Diagnosis and management of hymenoptera venom allergy: British Society for Allergy and Clinical Immunology (BSACI) guidelines. Clin Exp Allergy. 2011 Sep;41(9):1201-20. doi: 10.1111/j.1365-2222.2011.03788.x.
PubMed 21848758Ruiz-Leon B, Martinez San Ireneo M, de la Roca F, Arenas L, Alfaya Arias T, Cordobes C, Marques L, Vega A, Moreno-Aguilar C. The Lights and the Shadows of Controlled Sting Challenge With Hymenoptera. J Investig Allergol Clin Immunol. 2022 Oct 11;32(5):357-366. doi: 10.18176/jiaci.0838. Epub 2022 Jun 22.
PubMed 35735250Alfaya T, Vega A, Dominguez-Noche C, Ruiz B, Marques L, Sanchez-Morillas L. Longitudinal Validation of the Spanish Version of the Health-Related Quality of Life Questionnaire for Hymenoptera Venom Allergy (HRQLHA). J Investig Allergol Clin Immunol. 2015;25(6):426-30.
PubMed 26817139
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
- ClinicalTrials.gov ID
- NCT06790368
- Acronym / sponsor ID
- Venox-23 / ITK-VENOX-2023-01
- Keywords
- Allergy, Immunotherapy, Apis mellifera, Vespula sp, controlled sting
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Jan 2025 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 24 Jan 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.
Observational clinical follow-up to evaluate the safety of immunotherapy for the treatment of hymenoptera venom allergy in real-life conditions. It includes the evaluation of controlled and spontaneous stings. This study will be conducted in Spain (multicentric), multicentric and data will be collected prospectively.
Detailed description
Observational, multicentric (Spain), prospective study and data will be collected properly. The total number of participants is expected to be 80. The patients aged equal or more than 14 years old, sentitized to himenoptera venom, not gender differentiation.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients allergic to hymenoptera venom | – | Biological: VENOXPatients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX inmunotherapy (ATC code: V01AA07) |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants of both gender aged 14 years or more diagnosed of allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive ITVH according to standard clinical practice.
Key inclusion criteria (4 listed)
- The study population consisted of allergic participants indicated for treatment with hymenoptera venom immunotherapy (Apis mellifera or Vespula spp.) according to standard clinical practice.
- Participants of both sexes aged 14 years or more.
- Participants who have not received immunotherapy with hymenoptera venom in the previous 5 years.
- Participants who have agreed to take part in the study and sign the informed consent form. In the case of minors, the patient's parent or guardian must also sign.
Key exclusion criteria (4 listed)
- Pregnant or breastfeeding women.
- Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.
- Participants who do not agree to participate and/or do not sign the informed consent form.
- Participants who do not comply with medical indications or do not cooperate with immunotherapy treatment.
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 |
|---|---|---|
| VENOXTreatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication. | Biological | Patients allergic to hymenoptera venom |
Primary outcome
Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).
Time frame: 12 months
Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).
3 secondary outcomes
Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural stings during the 1-year follow-up.
Time frame: 12 months
Immunological parameters of the participants after 12 months of treatment.
Time frame: 12 months
SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.
Time frame: 12 months
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 1 May 2025.
- Background: PubMed 21848758Krishna MT, Ewan PW, Diwakar L, Durham SR, Frew AJ, Leech SC, Nasser SM; British Society for Allergy and Clinical Immunology. Diagnosis and management of hymenoptera venom allergy: British Society for Allergy and Clinical Immunology (BSACI) guidelines. Clin Exp Allergy. 2011 Sep;41(9):1201-20. doi: 10.1111/j.1365-2222.2011.03788.x.
- Background: PubMed 35735250Ruiz-Leon B, Martinez San Ireneo M, de la Roca F, Arenas L, Alfaya Arias T, Cordobes C, Marques L, Vega A, Moreno-Aguilar C. The Lights and the Shadows of Controlled Sting Challenge With Hymenoptera. J Investig Allergol Clin Immunol. 2022 Oct 11;32(5):357-366. doi: 10.18176/jiaci.0838. Epub 2022 Jun 22.
- Background: PubMed 26817139Alfaya T, Vega A, Dominguez-Noche C, Ruiz B, Marques L, Sanchez-Morillas L. Longitudinal Validation of the Spanish Version of the Health-Related Quality of Life Questionnaire for Hymenoptera Venom Allergy (HRQLHA). J Investig Allergol Clin Immunol. 2015;25(6):426-30.
- Comite de Alergia a Himenopteros. "Cuestionario de Calidad de Vida en Alérgicos a Himenópteros".Link provided by the sponsor.
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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.
Arantza Vega Castro principal investigator
University of Guadalajara
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Allergy, Insect Venom and Allergy Insect Stinging, run by Inmunotek S.L. at 3 sites in Spain.
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 4 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 1 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Spain. 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 Miguel Casanovas (+34 91208942, mcasanovas@inmunotek.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.). (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06790368, which also lists 3 linked publications.
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 1 May 2025.