Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure

NCT04259359 | Recruiting

• 1 other identifier: 31-238 ex 18/19 (PREDICT)
• Study Type: observational
• Target: 266
• Locations: 3 countries
• Sites: 3

Brief Summary

Venom immunotherapy (VIT) is an established treatment for Hymenoptera venom allergy and provides long-term protection from further generalized reactions in almost all patients. However, it is still unclear why bee VIT is less effective than vespid VIT. The preliminary data show that not only predominant Api m 10 sensitization but also other predominant sensitizations may be relevant as risk factors for treatment failure. Interestingly, all patients with a predominant Api m 10 sensitization who received bee VIT with a venom preparation with a supposed lack of Api m 10 tolerated sting challenges. Therefore, a multicenter study with a sufficient number of patients with treatment failure is urgently required, to clarify if predominant sensitization to a bee venom allergen is a risk factor for treatment failure. If predominant sensitization is a risk factor and caused by underrepresented components in bee venom preparations used for VIT, bee venom preparations may be optimized in the future and patients would benefit from a more effective VIT.

Conditions

Bee Venom Allergy

Outcome Measures

Primary Outcomes (1)

• The primary objective of the study is to evaluate whether predominant sensitization to Api m 10 is a risk factor for treatment failure.

  A sensitization is considered predominant if the proportion of specific IgE to a single venom allergen is at least 65% of the specific IgE to the venom preparations.

  depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose

Secondary Outcomes (4)

• To evaluate if predominant sensitization to either Api m 1, Api m 2, Api m 3 or Api m 5 is a risk factor for treatment failure.

  depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose

• To evaluate if low immunoglobulin G4 (IgG4) levels to bee venom or to Api m 1, Api m 2, Api m 3, Api m 5, or Api m 10 after VIT is a risk factor for treatment failure.

  depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose

• To evaluate if systemic side effects are a risk factor for treatment failure.

  depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose

• To evaluate if antihypertensive medication is a risk factor for treatment failure.

  depends on the protocol used for VIT and the date of the sting challenge, a maximum of about 6 months if sting challenge is performed right after reaching the maintenance dose

Study Arms (1)

patients who will be treated with bee venom immunotherapy

Drug: Insect Venom

Interventions

Insect Venom DRUG

Patients will be treated with bee venom immunotherapy (protocol can be selected by patient). Blood samples are taken before starting VIT to determine specific immunoglobulin E (sIgE) Levels for bee venom components. Patients are sting challenged and the outcome will be recorded.

patients who will be treated with bee venom immunotherapy

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patients who will be treated with bee venom immunotherapy

You may qualify if:

• Legally competent male and female subjects aged from 18 to 70 years with a history of a systemic anaphylactic sting reaction (≥ grade I according to the classification of Ring and Messmer) after bee stings, who will receive bee venom immunotherapy

You may not qualify if:

• Contraindications to VIT

Sponsors & Collaborators

• Medical University of Graz: lead

Study Sites (3)

Department of Dermatology and Venerology, Medical University of Graz

Graz, 8036, Austria

RECRUITING

Elbe Klinikum Buxtehude

Buxtehude, 21614, Germany

RECRUITING

Hospital Universitario de Castellón

Castellon, 12004, Spain

RECRUITING

MeSH Terms

Conditions

Venom Hypersensitivity

Interventions

Arthropod Venoms

Condition Hierarchy (Ancestors)

Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Venoms; Complex Mixtures; Toxins, Biological; Biological Factors

Central Study Contacts

Gunter J Sturm, MD, PhD

CONTACT

+4331638580318; gunter.sturm@medunigraz.at

Lisa Arzt-Gradwohl, PhD

CONTACT

+4331638578039; lisa.arzt@medunigraz.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 5, 2020
• First Posted: February 6, 2020
• Study Start: May 2, 2019
• Primary Completion: December 1, 2025
• Study Completion: March 1, 2026
• Last Updated: December 8, 2025

Record last verified: 2025-12

Locations

AU (1); DE (1); ES (1)