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NCT Number: NCT06790368

Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.

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.

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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 Universitario Fundación Alcorcón, Alcorcón, Madrid, Spain

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About this study

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.

Who can participate

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

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.

Treatment and study plan

VENOX

Biological

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

Primary outcomes

  1. Incidence of treatment-Emergent adverse reactions (safety and tolerability) in participants diagnosed with allergy to hymenoptera venom (Apis mellifera and/or Vespula spp.).

    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 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.

    Time frame: 12 months

    Registration of allergic reactions, spontaneous natural stings and a controlled sting test in participants sensitised to hymenoptera venom (Apis mellifera and/or Vespula spp.).

  2. Immunological parameters of the participants after 12 months of treatment.

    Time frame: 12 months

    Immunological study: total IgE, 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 site and the serum samples will be stored for the complete analysis in the facilities of the sponsor, using the ALEX technique.

  3. SEAIC (Spanish Society of Allergology and Clinical Immunology) Quality of life Questionnaire for people allergic to hymenoptera venom.

    Time frame: 12 months

    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 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, with 1 indicating the worst quality of life and 7 the best.

Study contacts

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

Miguel Casanovas

CONTACT

[email protected]

+34 91208942

Raquel Caballero

CONTACT

[email protected]

+34 607600638

Sponsors and collaborators

Lead sponsor

Inmunotek S.L.

Industry

Registry information

Official study title

Prospective Clinical Follow-up to Evaluate the Safety of Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions.

Acronym: Venox-23

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 24, 2025
Registry last updated
May 1, 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.

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