Immunotherapy for the Treatment of Hymenoptera Venom Allergy in Real-life Conditions. (Venox-23)

April 30, 2025 updated by: Inmunotek S.L.

Prospective Clinical Follow-up to Evaluate the Safety of 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Estimated)

80

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Spain
      • Córdoba, Spain
        • Recruiting
        • Hospital Reina Sofia
        • Contact:
      • Guadalajara, Spain, 19002
        • Recruiting
        • Hospital Universitario de Guadalajara
        • Contact:
        • Sub-Investigator:
          • Juan María Beitia Mazuecos
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Recruiting
        • Hospital Universitario Fundación Alcorcón
        • Contact:
        • Sub-Investigator:
          • Jesús Macías Iglesias

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

N/A

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Patients allergic to hymenoptera venom
Patients allergic to hymenoptera venom and receive the clinical recommendation to be treated with VENOX inmunotherapy (ATC code: V01AA07)
Biological: VENOX
Treatment with allergy vaccine against Vespula spp. (wasp) or Apis mellifera (bee), as per clinical indication.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.).
12 months
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.
12 months
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.
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Inmunotek S.L.

Investigators

  • Principal Investigator: Arantza Vega Castro, Hospital Universitario de Guadalajara

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2025

Primary Completion (Estimated)

March 1, 2026

Study Completion (Estimated)

June 1, 2026

Study Registration Dates

First Submitted

September 16, 2024

First Submitted That Met QC Criteria

January 17, 2025

First Posted (Actual)

January 24, 2025

Study Record Updates

Last Update Posted (Actual)

May 1, 2025

Last Update Submitted That Met QC Criteria

April 30, 2025

Last Verified

April 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ITK-VENOX-2023-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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