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

NCT06782217 | Recruiting

• 1 other identifier: ITK-VENOX-2024-01
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 9

Brief 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.

Conditions

Allergy, Insect Venom; Allergy Insect Stinging; Insect Sting Allergy

Keywords

Allergy; Immunothepary; Apis mellifera; Vespula spp.; Insect venom

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Evaluation of the immunogenicity of the participant after 6 and 12 months of treatment.

  12 months

• Quality of life in treated participants after 6 and 12 months of treatment.

  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.

  12 months

Study Arms (1)

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

Interventions

VENOX BIOLOGICAL

Treatment with allergy vaccine againts Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.

Patients allergic to hymenoptera venom

Eligibility Criteria

• Age: 14 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Inmunotek S.L.: lead

Study Sites (9)

Hospital Arquitecto Marcide

Ferrol, A Coruña, 15405, Spain

NOT YET RECRUITING

Hospital Virgen del Puerto Plasencia

Plasencia, Cáceres, 10600, Spain

RECRUITING

Hospital Público Da Mariña

Burela de Cabo, Lugo, 27880, Spain

RECRUITING

Hospital Comarcal de Monforte de Lemos

Monforte de Lemos, Lugo, 27400, Spain

RECRUITING

Hospital de A Coruña

A Coruña, 15006, Spain

RECRUITING

Hospital Vall d' Hebron

Barcelona, 08035, Spain

RECRUITING

Hospital Universitario Lucus Augusti

Lugo, 27003, Spain

RECRUITING

Complejo Hospitalario Universitario de Ourense

Ourense, 32005, Spain

RECRUITING

Hospital Universitario de Pontevedra

Pontevedra, 36071, Spain

RECRUITING

Related Publications (4)

• 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.

  PMID: 12110838 BACKGROUND

• 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.

  PMID: 15753884 BACKGROUND

• 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.

  PMID: 3310714 BACKGROUND

• 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.

  PMID: 34206562 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood serum to perform immunological study of total IgE, and specific IgE, IgG4, IgG1.

MeSH Terms

Conditions

Venom Hypersensitivity; Hypersensitivity

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Immune System Diseases

Study Officials

• Francisco Javier Carballada, MD

  Hospital Universitario Lucus Augusti

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Miguel Casanovas, MD

CONTACT

+3491208942; mcasanovas@inmunotek.com

Raquel Caballero, BSc

CONTACT

+34607600638; rcaballero@inmunotek.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2024
• First Posted: January 17, 2025
• Study Start: September 1, 2024
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): February 1, 2027
• Last Updated: May 4, 2025

Record last verified: 2025-04

Locations

ES (9)