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

Inmunotek

Status: Enrolling

Conditions: Insect Sting Allergy; Allergy, Insect Venom; Allergy Insect Stinging

Treatments: Biological: VENOX

Study type: Observational

Funder types: Industry

Identifiers

NCT06782217

ITK-VENOX-2024-01

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: All

Ages: 14+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

120 participants in 1 patient group

Patients allergic to hymenoptera venom

Description:

Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX immunotherapy (ATC code: V01AA07).

Treatment:

Biological: VENOX