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

Обзор

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.

Вмешательства

• Препарат Insect Venom
  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.

Первичные конечные точки

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

Вторичные конечные точки (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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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. [Срок оценки: 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]

Критерии участия

Критерии включения

• 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

Критерии исключения

• Contraindications to VIT

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения

Когортное

Центры проведения

Австрия · 1 центр

• Department of Dermatology and Venerology, Medical University of Graz — Graz

Германия · 1 центр

• Elbe Klinikum Buxtehude — Buxtehude

Испания · 1 центр

• Hospital Universitario de Castellón — Castellon

Идентификаторы

NCT: NCT04259359 · 31-238 ex 18/19 (PREDICT)

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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