PDF(Pubmed)
Abstract：
UNASSIGNED: Polymerized allergoids conjugated with mannan represent a novel approach of allergen immunotherapy targeting dendritic cells. In this study, we aimed to determine the optimal dose of mannan-allergoid conjugates derived from grass pollen (Phleum pratense and Dactylis glomerata) administered via either the subcutaneous or sublingual route.
UNASSIGNED: A randomized, double-blind, placebo-controlled trial with a double-dummy design was conducted, involving 162 participants across 12 centers in Spain. Subjects were randomly allocated to one of nine different treatment groups, each receiving either placebo or active treatment at doses of 500, 1,000, 3,000, or 5,000 mTU/mL over four months. Each participant received five subcutaneous (SC) doses of 0.5 mL each, every 30 days, and a daily sublingual (SL) dose of 0.2 mL. Participants who received active treatment through SC, received placebo through SL. Participants who received active treatment through SL, received placebo SC. One Group, as control, received bot SC and SL placebo. The primary efficacy outcome was the improvement in titrated nasal provocation tests (NPT) at the end of the study compared to baseline. Secondary outcomes included specific antibody (IgG4, IgE) and cellular (IL-10 producing and regulatory T cell) responses. All adverse events and side reactions were recorded and assessed.
UNASSIGNED: Post-treatment, the active groups showed improvements in NPT ranging from 33% to 53%, with the highest doses showing the greatest improvements regardless of the administration route. In comparison, the placebo group showed a 12% improvement. Significant differences over placebo were observed at doses of 3,000 mTU/mL (p=0.049 for SL, p=0.015 for SC) and 5,000 mTU/mL (p=0.011 for SL, p=0.015 for SC). A dose-dependent increase in IgG4 was observed following SC administration, and an increase in IL-10 producing cells for both routes of administration. No serious systemic or local adverse reactions were recorded, and no adrenaline was required.
UNASSIGNED: Grass pollen immunotherapy with mannan-allergoid conjugates was found to be safe and efficacious in achieving the primary outcome, whether administered via the subcutaneous or sublingual routes, at doses of 3,000 and 5,000 mTU/mL.
UNASSIGNED: https://www.clinicaltrialsregister.eu/ctr-search (EudraCT), identifier 2014-005471-88; https://www.clinicaltrials.gov, identifier NCT02654223.
UNASSIGNED: A randomized, double-blind, placebo-controlled trial with a double-dummy design was conducted, involving 162 participants across 12 centers in Spain. Subjects were randomly allocated to one of nine different treatment groups, each receiving either placebo or active treatment at doses of 500, 1,000, 3,000, or 5,000 mTU/mL over four months. Each participant received five subcutaneous (SC) doses of 0.5 mL each, every 30 days, and a daily sublingual (SL) dose of 0.2 mL. Participants who received active treatment through SC, received placebo through SL. Participants who received active treatment through SL, received placebo SC. One Group, as control, received bot SC and SL placebo. The primary efficacy outcome was the improvement in titrated nasal provocation tests (NPT) at the end of the study compared to baseline. Secondary outcomes included specific antibody (IgG4, IgE) and cellular (IL-10 producing and regulatory T cell) responses. All adverse events and side reactions were recorded and assessed.
UNASSIGNED: Post-treatment, the active groups showed improvements in NPT ranging from 33% to 53%, with the highest doses showing the greatest improvements regardless of the administration route. In comparison, the placebo group showed a 12% improvement. Significant differences over placebo were observed at doses of 3,000 mTU/mL (p=0.049 for SL, p=0.015 for SC) and 5,000 mTU/mL (p=0.011 for SL, p=0.015 for SC). A dose-dependent increase in IgG4 was observed following SC administration, and an increase in IL-10 producing cells for both routes of administration. No serious systemic or local adverse reactions were recorded, and no adrenaline was required.
UNASSIGNED: Grass pollen immunotherapy with mannan-allergoid conjugates was found to be safe and efficacious in achieving the primary outcome, whether administered via the subcutaneous or sublingual routes, at doses of 3,000 and 5,000 mTU/mL.
UNASSIGNED: https://www.clinicaltrialsregister.eu/ctr-search (EudraCT), identifier 2014-005471-88; https://www.clinicaltrials.gov, identifier NCT02654223.
摘要：
与甘露聚糖缀合的聚合类变应原免疫疗法代表靶向树突细胞的新方法。在这项研究中,我们旨在确定通过皮下或舌下途径施用的源自草花粉的甘露聚糖-类过敏结合物（Phleumpratense和Dactylisglomerata）的最佳剂量。
■随机，双盲,采用双假人设计的安慰剂对照试验，涉及西班牙12个中心的162名参与者。受试者被随机分配到九个不同的治疗组之一，每个人在4个月内接受500,1,000,3,000或5,000mTU/mL剂量的安慰剂或活性治疗.每位参与者接受5次皮下（SC）剂量，每次0.5mL，每30天,和0.2mL的每日舌下(SL)剂量。通过SC接受积极治疗的参与者，通过SL接受安慰剂。通过SL接受积极治疗的参与者，接受安慰剂SC。一组,作为控制,接受了BotSC和SL安慰剂。主要疗效结果是与基线相比，研究结束时滴定鼻激发试验（NPT）的改善。次要结果包括特异性抗体（IgG4，IgE）和细胞（IL-10产生和调节性T细胞）反应。记录并评估所有不良事件和副反应。
■后处理，活跃群体在NPT中表现出从33%到53%的改善，无论给药途径如何，最高剂量显示出最大的改善。相比之下,安慰剂组改善了12%.在3,000mTU/mL的剂量下观察到与安慰剂的显着差异（对于SL，p=0.049，SC的p=0.015）和5,000mTU/mL（SL的p=0.011，SC的p=0.015)。SC给药后观察到IgG4的剂量依赖性增加，以及两种给药途径中产生IL-10的细胞增加。没有严重的全身或局部不良反应记录。不需要肾上腺素。
用甘露聚糖-类过敏结合物进行草花粉免疫疗法在达到主要结果方面是安全有效的。无论是通过皮下或舌下途径给药，剂量为3,000和5,000mTU/mL。
■https://www.临床试验登记。欧盟/ctr搜索(EudraCT)，标识符2014-005471-88;https://www.clinicaltrials.gov,标识符NCT02654223。
■随机，双盲,采用双假人设计的安慰剂对照试验，涉及西班牙12个中心的162名参与者。受试者被随机分配到九个不同的治疗组之一，每个人在4个月内接受500,1,000,3,000或5,000mTU/mL剂量的安慰剂或活性治疗.每位参与者接受5次皮下（SC）剂量，每次0.5mL，每30天,和0.2mL的每日舌下(SL)剂量。通过SC接受积极治疗的参与者，通过SL接受安慰剂。通过SL接受积极治疗的参与者，接受安慰剂SC。一组,作为控制,接受了BotSC和SL安慰剂。主要疗效结果是与基线相比，研究结束时滴定鼻激发试验（NPT）的改善。次要结果包括特异性抗体（IgG4，IgE）和细胞（IL-10产生和调节性T细胞）反应。记录并评估所有不良事件和副反应。
■后处理，活跃群体在NPT中表现出从33%到53%的改善，无论给药途径如何，最高剂量显示出最大的改善。相比之下,安慰剂组改善了12%.在3,000mTU/mL的剂量下观察到与安慰剂的显着差异（对于SL，p=0.049，SC的p=0.015）和5,000mTU/mL（SL的p=0.011，SC的p=0.015)。SC给药后观察到IgG4的剂量依赖性增加，以及两种给药途径中产生IL-10的细胞增加。没有严重的全身或局部不良反应记录。不需要肾上腺素。
用甘露聚糖-类过敏结合物进行草花粉免疫疗法在达到主要结果方面是安全有效的。无论是通过皮下或舌下途径给药，剂量为3,000和5,000mTU/mL。
■https://www.临床试验登记。欧盟/ctr搜索(EudraCT)，标识符2014-005471-88;https://www.clinicaltrials.gov,标识符NCT02654223。
