Clinical trial NCT06782217: Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
Official title: Prospective Observational Study to Evaluate the Safety of Immunotherapy as a Treatment for Hymenoptera Venom Allergy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Allergy, Insect Venom
Allergy Insect Stinging
Insect Sting Allergy
Keywords: Allergy
Immunothepary
Apis mellifera
Vespula spp.
Insect venom
Lead sponsor: Inmunotek S.L.
Sponsor class: INDUSTRY
First posted: 2025-01-17
Enrollment: 120
Sex: ALL
Minimum age (years): 14
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
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.
timeFrame: 12 months
Secondary outcomes:
measure: Evaluation of the immunogenicity of the participant after 6 and 12 months of treatment.
timeFrame: 12 months
measure: Quality of life in treated participants after 6 and 12 months of treatment.
timeFrame: 12 months
measure: 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.
timeFrame: 12 months
Other outcomes:
Locations:
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide
state: A Coruña
city: Plasencia
country: Spain
facility: Hospital Virgen del Puerto Plasencia
state: Cáceres
city: Burela De Cabo
country: Spain
facility: Hospital Público Da Mariña
state: Lugo
city: Monforte De Lemos
country: Spain
facility: Hospital Comarcal de Monforte de Lemos
state: Lugo
city: A Coruña
country: Spain
facility: Hospital de A Coruña
city: Barcelona
country: Spain
facility: Hospital Vall d' Hebron
city: Lugo
country: Spain
facility: Hospital Universitario Lucus Augusti
city: Ourense
country: Spain
facility: Complejo Hospitalario Universitario de Ourense
city: Pontevedra
country: Spain
facility: Hospital Universitario de Pontevedra
Study officials:
affiliation: Hospital Universitario Lucus Augusti
name: Francisco Javier Carballada, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.