Allergy, Insect VenomNCT06782217
Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
An observational study of Allergy, Insect Venom and Allergy Insect Stinging, run by Inmunotek S.L. at 9 sites in Spain.
Trial summary
Observational study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (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
- 120 participants
- Where
- 9 sitesSpain
- Study dates
- 1 Sep 2024to 1 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 14 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Participants aged 14 years and older diagnosed with allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive immunotherapy wit himenoptera venom according to standard clinical practice.
Who may be able to join
- The study population consisted of allergic participants indicated for treatment with immunotherapy with hymenoptera venom (Apis mellifera or Vespula spp.) according to standard clinical practice.
- Age equal to or older than 14 years, without gender differences.
- Not having received immunotherapy with hymenoptera venom in the previous 5 years.
- That they agree to participate in the study and sign the informed consent form. In the case of minors, the parent or guardian of the participant must also sign the informed consent form.
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 the medical indications or do not show cooperation with respect to the immunotherapy treatment.
- Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive treatment.
- Participants in whom the administration of immunotherapy is contraindicated.
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
Spain9 sites, 9 recruiting
- Recruiting
Hospital de A Coruña
A Coruña, 15006
Antonio Parra Arrondo, +34 981178000, antonio.parra.arrondo@sergas.es
Antonio Parra Arrondo
- Recruiting
Hospital Vall d' Hebron
Barcelona, 08035
Moisés Labrador, +34 932746000, moises.labrador@vallhebron.cat
Moisés Labrador
- Recruiting
Hospital Público Da Mariña
Burela de Cabo, Lugo, 27880
Nicola Giangrande, +34 982589900, giangrande.nicola@gmail.com
Nicola Giangrande
- Not yet recruiting
Hospital Arquitecto Marcide
Ferrol, A Coruña, 15405
Vanesa García Paz, +34 981334000, vanesa.garcia.paz@sergas.es
Vanesa García Paz
- Recruiting
Hospital Universitario Lucus Augusti
Lugo, 27003
Francisco Carballada, +34 982296000, francisco.carballada.gonzalez@sergas.es
Francisco Javier Carballada
- Recruiting
Hospital Comarcal de Monforte de Lemos
Monforte de Lemos, Lugo, 27400
Luis Alfredo González Guzmán, +34 982417900, alfredo1651@yahoo.es
Luis Alfredo González Guzmán
- Recruiting
Complejo Hospitalario Universitario de Ourense
Ourense, 32005
María del Mar García Álvarez-Eyré, +34 988385500, genoveva.marimar.garcia.alvarez-eire@sergas.es
María del Mar García Álvarez-Eyré
- Recruiting
Hospital Virgen del Puerto Plasencia
Plasencia, Cáceres, 10600
Carmen Domínguez Noche, +34 927428300, carmendomingueznoche@gmail.com
Carmen Domínguez Noche
- Recruiting
Hospital Universitario de Pontevedra
Pontevedra, 36071
Tania Liñares Mata, +34 986800132, tania.linares.mata@sergas.es
Tania Liñares Mata
About this study
Observational study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (multicentric) and data will be collected prospectively.
Read the detailed description
Observational study to evaluate the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting (safety evaluation), also it will be evulated the quality of life of the patient using one QoL questionnair before and after immunotherapy treatment.
The patients aged equal or more than 14 years old, not gender differentiation, and sensitised to heminoptera venom. The total number of participants is expected to be 120.
This study will be conducted in Spain (multicentric) and data will be collected prospectively.
- Being tested
- VENOX
- Keywords
- Allergy, Immunothepary, Apis mellifera, Vespula spp., Insect venom
- 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 againts 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 immunotherapy (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 patients diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.) with indication to receive immunotherapy with the causative venom.
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 immunogenicity of the participant after 6 and 12 months of treatment.
Immunological study: total IgE, and 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 center and the serum samples will be stored for the complete analysis in the facilities of the sponsor, using the ALEX technique.
Measured: 12 months
Quality of life in treated participants after 6 and 12 months of treatment.
Questionnaire of "Quality of Life in People Allergic to Hymenoptera Venom" (HiCaVi), property/copyright of SEAIC (Sociedad Española de Alergología e Inmunología Clínica).
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 answer scores 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, being the 1 the worst quality and the 7 the best one.
Measured: 12 months
Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural repicures during the 1-year follow-up.
Registration of allergic reactions after spontaneous natural stings.
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 posted17 Jan 2025
- Study start1 Sep 2024
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)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
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Inmunotek S.L.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Francisco Javier Carballada, MD, Principal investigator, Hospital Universitario Lucus Augusti
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06782217
- Sponsor's protocol ID
- ITK-VENOX-2024-01
- Status last verified
- Apr 2025
- First submitted
- 16 Sep 2024
- Last updated
- 4 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Oude Elberink JN, De Monchy JG, Van Der Heide S, Guyatt GH, Dubois AE. Venom immunotherapy improves health-related quality of life in patients allergic to yellow jacket venom. J Allergy Clin Immunol. 2002 Jul;110(1):174-82. doi: 10.1067/mai.2002.125827.
PubMed 12110838Golden DB. Insect sting allergy and venom immunotherapy: a model and a mystery. J Allergy Clin Immunol. 2005 Mar;115(3):439-47; quiz 448. doi: 10.1016/j.jaci.2005.01.005.
PubMed 15753884Bousquet J, Muller UR, Dreborg S, Jarisch R, Malling HJ, Mosbech H, Urbanek R, Youlten L. Immunotherapy with Hymenoptera venoms. Position paper of the Working Group on Immunotherapy of the European Academy of Allergy and Clinical Immunology. Allergy. 1987 Aug;42(6):401-13. doi: 10.1111/j.1398-9995.1987.tb00355.x.
PubMed 3310714Demsar Luzar A, Korosec P, Kosnik M, Zidarn M, Rijavec M. Hymenoptera Venom Immunotherapy: Immune Mechanisms of Induced Protection and Tolerance. Cells. 2021 Jun 22;10(7):1575. doi: 10.3390/cells10071575.
PubMed 34206562
Study at a glance
From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
- ClinicalTrials.gov ID
- NCT06782217
- Acronym / sponsor ID
- ITK-VENOX-2024-01
- Keywords
- Allergy, Immunothepary, Apis mellifera, Vespula spp., Insect venom
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Inmunotek S.L.Industry (pharma, biotech, devices)
- Study start
- 1 Sep 2024 (actual)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 17 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 study to evaluate the safety of immunotherapy as a treatment for Hymenoptera venom allergy, analyzing the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting. This study will be conducted in Spain (multicentric) and data will be collected prospectively.
Detailed description
Observational study to evaluate the adverse reaction to immunotherapy as well as the allergic reaction to a spontaneous hymenoptera sting (safety evaluation), also it will be evulated the quality of life of the patient using one QoL questionnair before and after immunotherapy treatment.
The patients aged equal or more than 14 years old, not gender differentiation, and sensitised to heminoptera venom. The total number of participants is expected to be 120.
This study will be conducted in Spain (multicentric) and data will be collected prospectively.
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 immunotherapy (ATC code: V01AA07). |
Who may qualify
- Ages
- 14 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Participants aged 14 years and older diagnosed with allergy to Apis mellifera and/or Vespula spp. venom, susceptible to receive immunotherapy wit himenoptera venom according to standard clinical practice.
Key inclusion criteria (4 listed)
- The study population consisted of allergic participants indicated for treatment with immunotherapy with hymenoptera venom (Apis mellifera or Vespula spp.) according to standard clinical practice.
- Age equal to or older than 14 years, without gender differences.
- Not having received immunotherapy with hymenoptera venom in the previous 5 years.
- That they agree to participate in the study and sign the informed consent form. In the case of minors, the parent or guardian of the participant must also sign the informed consent form.
Key exclusion criteria (6 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 the medical indications or do not show cooperation with respect to the immunotherapy treatment.
- Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive 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 againts 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 patients diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.) with indication to receive immunotherapy with the causative venom.
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 immunogenicity of the participant after 6 and 12 months of treatment.
Time frame: 12 months
Quality of life in treated participants after 6 and 12 months of treatment.
Time frame: 12 months
Evaluation of the effectiveness of treatment with immunotherapy, once the maintenance dose of 100 μg/mL is reached, in participants suffering spontaneous natural repicures during the 1-year follow-up.
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 4 May 2025.
- Background: PubMed 12110838Oude Elberink JN, De Monchy JG, Van Der Heide S, Guyatt GH, Dubois AE. Venom immunotherapy improves health-related quality of life in patients allergic to yellow jacket venom. J Allergy Clin Immunol. 2002 Jul;110(1):174-82. doi: 10.1067/mai.2002.125827.
- Background: PubMed 15753884Golden DB. Insect sting allergy and venom immunotherapy: a model and a mystery. J Allergy Clin Immunol. 2005 Mar;115(3):439-47; quiz 448. doi: 10.1016/j.jaci.2005.01.005.
- Background: PubMed 3310714Bousquet J, Muller UR, Dreborg S, Jarisch R, Malling HJ, Mosbech H, Urbanek R, Youlten L. Immunotherapy with Hymenoptera venoms. Position paper of the Working Group on Immunotherapy of the European Academy of Allergy and Clinical Immunology. Allergy. 1987 Aug;42(6):401-13. doi: 10.1111/j.1398-9995.1987.tb00355.x.
- Background: PubMed 34206562Demsar Luzar A, Korosec P, Kosnik M, Zidarn M, Rijavec M. Hymenoptera Venom Immunotherapy: Immune Mechanisms of Induced Protection and Tolerance. Cells. 2021 Jun 22;10(7):1575. doi: 10.3390/cells10071575.
Related trials for Allergy, Insect Venom
RecruitingObservational study
Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Allergy, Insect Venom, Allergy Insect Stinging
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.
Francisco Javier Carballada, MD principal investigator
Hospital Universitario Lucus Augusti
9 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 9 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 6 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 4 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 9 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, MD (+3491208942, 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 patients diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.) with indication to receive immunotherapy with the causative venom. (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 NCT06782217, which also lists 4 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 4 May 2025.