Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy

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.

Study Overview

• Status: Recruiting
• Conditions: Insect Sting Allergy; Allergy, Insect Venom; Allergy Insect Stinging
• Intervention / Treatment: Biological: VENOX

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 Type: Observational
• Enrollment (Estimated): 120

Contacts and Locations

• Study Contact: Name: Raquel Caballero, BSc; Phone Number: +34607600638; Email: rcaballero@inmunotek.com
• Study Contact Backup: Name: Miguel Casanovas, MD; Phone Number: +3491208942; Email: mcasanovas@inmunotek.com

Study Locations

• Spain
  • A Coruña, Spain, 15006
    • Recruiting
    • Hospital de A Coruña
    • Contact: Antonio Parra Arrondo; Phone Number: +34 981178000; Email: antonio.parra.arrondo@sergas.es
    • Principal Investigator: Antonio Parra Arrondo
  • Barcelona, Spain, 08035
    • Recruiting
    • Hospital Vall d' Hebron
    • Contact: Moisés Labrador; Phone Number: +34 932746000; Email: moises.labrador@vallhebron.cat
    • Principal Investigator: Moisés Labrador
  • Lugo, Spain, 27003
    • Recruiting
    • Hospital Universitario Lucus Augusti
    • Contact: Francisco Carballada; Phone Number: +34 982296000; Email: francisco.carballada.gonzalez@sergas.es
    • Principal Investigator: Francisco Javier Carballada
  • Ourense, Spain, 32005
    • Recruiting
    • Complejo Hospitalario Universitario de Ourense
    • Contact: María del Mar García Álvarez-Eyré; Phone Number: +34 988385500; Email: genoveva.marimar.garcia.alvarez-eire@sergas.es
    • Principal Investigator: María del Mar García Álvarez-Eyré
  • Pontevedra, Spain, 36071
    • Recruiting
    • Hospital Universitario de Pontevedra
    • Contact: Tania Liñares Mata; Phone Number: +34 986800132; Email: tania.linares.mata@sergas.es
    • Principal Investigator: Tania Liñares Mata
    • Sub-Investigator: Elena Escudero
  • A Coruña
    • Ferrol, A Coruña, Spain, 15405
      • Not yet recruiting
      • Hospital Arquitecto Marcide
      • Contact: Vanesa García Paz; Phone Number: +34 981334000; Email: vanesa.garcia.paz@sergas.es
      • Principal Investigator: Vanesa García Paz
  • Cáceres
    • Plasencia, Cáceres, Spain, 10600
      • Recruiting
      • Hospital Virgen del Puerto Plasencia
      • Contact: Carmen Domínguez Noche; Phone Number: +34 927428300; Email: carmendomingueznoche@gmail.com
      • Principal Investigator: Carmen Domínguez Noche
  • Lugo
    • Burela De Cabo, Lugo, Spain, 27880
      • Recruiting
      • Hospital Público da Mariña
      • Contact: Nicola Giangrande; Phone Number: +34 982589900; Email: giangrande.nicola@gmail.com
      • Principal Investigator: Nicola Giangrande
    • Monforte De Lemos, Lugo, Spain, 27400
      • Recruiting
      • Hospital Comarcal de Monforte de Lemos
      • Contact: Luis Alfredo González Guzmán; Phone Number: +34 982417900; Email: alfredo1651@yahoo.es
      • Principal Investigator: Luis Alfredo González Guzmán

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

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.

Description

Inclusion Criteria:

1. 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.
2. Age equal to or older than 14 years, without gender differences.
3. Not having received immunotherapy with hymenoptera venom in the previous 5 years.
4. 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.

Exclusion Criteria:

1. Pregnant or breastfeeding women.
2. Having received immunotherapy with hymenoptera venom during the 5 years prior to the start of the study.
3. Participants who do not agree to participate and/or do not sign the informed consent form.
4. Participants who do not comply with the medical indications or do not show cooperation with respect to the immunotherapy treatment.
5. Participants with oncological diseases under active treatment or with autoimmune diseases under immunosuppressive treatment.
6. Participants in whom the administration of immunotherapy is contraindicated.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients allergic to hymenoptera venom; Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX immunotherapy (ATC code: V01AA07).	Biological: VENOX; Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	12 months

Collaborators and Investigators

• Sponsor: Inmunotek S.L.
• Investigators: Principal Investigator: Francisco Javier Carballada, MD, Hospital Universitario Lucus Augusti

Publications and helpful links

General 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.
• Golden 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. Erratum In: J Allergy Clin Immunol. 2005 Jun;115(6):1128.
• Bousquet 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.
• Demsar 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.

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027

Study Registration Dates

• First Submitted: September 16, 2024
• First Submitted That Met QC Criteria: January 16, 2025
• First Posted (Actual): January 17, 2025

Study Record Updates

• Last Update Posted (Actual): May 4, 2025
• Last Update Submitted That Met QC Criteria: April 30, 2025
• Last Verified: April 1, 2025

More Information

Terms related to this study

• Keywords: Allergy; Immunothepary; Apis mellifera; Vespula spp.; Insect venom
• Additional Relevant MeSH Terms: Wounds and Injuries; Immune System Diseases; Hypersensitivity, Immediate; Chemically-Induced Disorders; Poisoning; Bites and Stings; Venom Hypersensitivity; Hypersensitivity; Insect Bites and Stings
• Other Study ID Numbers: ITK-VENOX-2024-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No