Randomized controlled trial demonstrating the benefits of delta inulin adjuvanted immunotherapy in patients with bee venom allergy
Randomized controlled trial demonstrating the benefits of delta inulin adjuvanted immunotherapy in patients with bee venom allergy
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DOI：
10.1016/j.jaci.2019.03.035
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发表时间：
2019-08-01
影响因子：
14.2
通讯作者：
Petrovsky, Nikolai
中科院分区：
文献类型：
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作者：
Heddle, Robert;Smith, Anthony;Petrovsky, Nikolai
背景：对膜翅目昆虫叮咬的过敏反应仍然是一个主要的全球性临床问题。虽然有效，但胃肠外脱敏方案需要使用昂贵的毒液提取物，并且需要在较长时间内频繁访问。目的：佐剂通常用于增强传染病疫苗的效力，本研究询问Advax是否（Vaxine Pty Ltd，阿德莱德，澳大利亚），一种新的非炎性多糖佐剂，可能为过敏脱敏提供类似的益处。在27名对蜜蜂叮咬有快速全身过敏反应史且特异性IgE水平阳性的成人中进行了一项随机对照1/2期试验，以评估蜂毒免疫疗法（HBVIT）联合Advax佐剂的安全性和有效性。毒液免疫疗法（VIT）每月进行30个月后，实现的维持doses.Results：Advax佐剂HBVIT耐受性良好。在VIT治疗第14周左右，两组特异性IgG（4）应答均达到峰值，但Advax佐剂组的特异性IgG（4）应答增加更早，峰值更高，并且在研究结束时保持得更好。观察到几种不同的VIT血清学应答模式;一些受试者具有优势IgG（4）应答，一些受试者具有IgG（4）和IgG（1）联合应答，一些受试者仅具有IgG（1）应答。在某些受试者中，特异性IgE水平在诱导阶段增加，然后下降，而在其他受试者中，特异性IgE水平从VIT.Conclusion开始逐渐下降：Advax佐剂有利地增强了HBVIT的免疫原性，早期和长期转换为特异性IgG（4）的产生。Advax佐剂增强VIT疗效的能力值得进一步研究。
Background: Allergic reactions to Hymenoptera insect stings remain a major global clinical problem. Although effective, parenteral desensitization regimens require use of costly venom extracts and require frequent visits over extended periods of time.Objective: Adjuvants are commonly used to enhance the efficacy of infectious disease vaccines, and this study asked whether Advax (Vaxine Pty Ltd, Adelaide, Australia), a novel noninflammatory polysaccharide adjuvant, might provide similar benefits for allergy desensitization.Methods: A randomized, controlled phase 1/2 trial was undertaken in 27 adults with a history of rapid-onset systemic allergic reactions to honeybee stings and positive specific IgE levels to evaluate the safety and efficacy of honeybee venom immunotherapy (HBVIT) combined with Advax adjuvant. Venom immunotherapy (VIT) was administered monthly for 30 months after achievement of maintenance doses.Results: Advax-adjuvanted HBVIT was well tolerated. Around week 14 of VIT, specific IgG(4) responses peaked in both groups but increased earlier, peaked higher, and were better maintained through the end of the study in the Advax-adjuvanted arm. Several different patterns of serologic response to VIT were seen; some subjects had a dominant IgG(4) response, some had a combined IgG(4) and IgG(1) response, and some had an exclusively IgG(1) response. In some subjects specific IgE levels increased during the induction phase and then decreased, whereas in others specific IgE levels progressively decreased from the start of VIT.Conclusion: Advax adjuvant favorably enhanced the immunogenicity of HBVIT, with an early and prolonged switch to specific IgG(4) production. The ability of Advax adjuvant to enhance VIT efficacy warrants further study.