Predominant Sensitizations to Single Bee Venom Allergens as a Risk Factor for Therapy Failure
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 266
- 试验地点
- 3
- 主要终点
- The primary objective of the study is to evaluate whether predominant sensitization to Api m 10 is a risk factor for treatment failure.
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Contraindications to VIT
研究组 & 干预措施
patients who will be treated with bee venom immunotherapy
干预措施: Insect Venom (Drug)
结局指标
主要结局
The primary objective of the study is to evaluate whether predominant sensitization to Api m 10 is a risk factor for treatment failure.
时间窗: 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
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.
次要结局
- 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 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 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)