Clinical trial NCT06790368: Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Official title: Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy, Insect Venom
Allergy Insect Stinging
Insect Sting Allergy
Keywords: Allergy
Immunotherapy
Apis mellifera
Vespula sp
controlled sting
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2025-01-24
Enrollment: 80
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).
timeFrame: 12 months
Secondary outcomes:
measure: 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.
timeFrame: 12 months
measure: Immunological parameters of the participants after 12 months of treatment.
timeFrame: 12 months
measure: SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.
timeFrame: 12 months
Other outcomes:
Locations:
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: Córdoba
country: Spain
facility: Hospital Reina Sofía
city: Guadalajara
country: Spain
facility: Hospital Universitario de Guadalajara
Study officials:
affiliation: Hospital Universitario de Guadalajara
name: Arantza Vega Castro
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Ruiz-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.
citation: Alfaya 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.