Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06782217

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.

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Allergy, Insect Venom Allergy Insect Stinging Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Insect Sting Allergy Venom Hypersensitivity

Age range

14 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Arquitecto Marcide, Ferrol, A Coruña, Spain

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

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 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.

Treatment and study plan

VENOX

Biological

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

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.

    Time frame: 12 months

    Evaluation of the severity of reactions in relation to subcutaneous immunotherapy following the indications proposed by the World Allergy Organization (WAO).

Secondary outcomes

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

    Time frame: 12 months

    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.

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

    Time frame: 12 months

    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.

  3. 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.

    Time frame: 12 months

    Registration of allergic reactions after spontaneous natural stings.

Study contacts

Contact information is provided by the study sponsor or research team.

Miguel Casanovas, MD

CONTACT

[email protected]

+3491208942

Raquel Caballero, BSc

CONTACT

[email protected]

+34607600638

Sponsors and collaborators

Lead sponsor

Inmunotek S.L.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2026
Study completion
2027
First posted
Jan 17, 2025
Registry last updated
May 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.