Safety, tolerability and efficacy of intradermal rabies immunization with DebioJectâ„¢
Safety, tolerability and efficacy of intradermal rabies immunization with DebioJectâ„¢
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DebioJect™ 皮内狂犬病免疫的安全性、耐受性和有效性
DOI：
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发表时间：
2017
期刊：
影响因子：
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通讯作者：
G. Pantaleo
中科院分区：
文献类型：
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作者：
P. Vescovo;N. Rettby;Nirinarilala Ramaniraka;J. Liberman;K. Hart;A. Cachemaille;L. Piveteau;R. Zanoni;P. Bart;G. Pantaleo
在一项单中心研究中，66名年龄在18至50岁之间的健康志愿者被随机分配到三种不同的注射途径进行狂犬病免疫接种：DebioJect（IDJ）皮内注射，标准皮内注射经典针头（IDS），也称为Mantoux方法，以及经典针头肌肉注射（IM）。在D 0、D 7和D28给予“巴氏狂犬病疫苗“和生理盐水（NaCl 0.9%）。两种皮内途径的抗原剂量均为IM剂量的1/5。比较IDJ与IDS和IM途径的耐受性、安全性和诱导的免疫原性。在所有疫苗接种访视时，在针头插入和产品注射时评价疼痛。在每次疫苗接种访视后，每天记录征集性不良事件（SolAE）和局部反应原性症状，包括疼痛、发红和瘙痒。在整个研究期间记录不良事件（AE）。通过使用快速荧光病灶抑制试验（RFFIT）评估狂犬病毒中和抗体（VNA）滴度来测量体液免疫应答。结果表明，DebioJect是一种安全、可靠和有效的器械。据报道，与IDS和IM相比，IDJ在针头插入和疫苗注射时的疼痛显著减轻。注射疫苗或生理盐水后，IDJ和IDS的所有局部反应原性症状（疼痛、发红和瘙痒）相似，但IDJ注射生理盐水后30 min引起更多发红。认为全身性SolAE与DebioJect和传统针头无关。认为无AE与DebioJect相关。研究期间未报告严重不良事件（SAE）。在研究结束时，认为所有参与者均接种了狂犬病疫苗，并且在3种研究途径之间未观察到体液应答的显著差异。2017作者由Elsevier Ltd.发布。这是CCBY-NC-ND许可证下的开放获取文章（http：//creativecommons.org/licenses/by-nc-nd/4.0/）。
In a single-center study, 66 healthy volunteers aged between 18 and 50 years were randomized to be immunized against rabies with three different injection routes: intradermal with DebioJect (IDJ), standard intradermal with classical needle (IDS), also called Mantoux method, and intramuscular with classical needle (IM). ‘‘Vaccin rabique Pasteur ” and saline solution (NaCl 0.9%) were administered at D0, D7 and D28. Antigen doses for both intradermal routes were 1/5 of the dose for IM. Tolerability, safety and induced immunogenicity of IDJ were compared to IDS and IM routes. Pain was evaluated at needle insertion and at product injection for all vaccination visits. Solicited Adverse Event (SolAE) and local reactogenicity symptoms including pain, redness and pruritus were recorded daily following each vaccination visit. Adverse events (AE) were recorded over the whole duration of the study. Humoral immune response was measured by assessing the rabies virus neutralizing antibody (VNA) titers using Rapid Fluorescent Focus Inhibition Test (RFFIT). Results demonstrated that the DebioJect is a safe, reliable and efficient device. Significant decreases of pain at needle insertion and at vaccine injection were reported with IDJ compared to IDS and IM. All local reactogenicity symptoms (pain, redness and pruritus) after injection with either vaccine or saline solution, were similar for IDJ and IDS, except that IDJ injection induced more redness 30 min after saline solution. No systemic SolAE was deemed related to DebioJect and classical needles. No AE was deemed related to DebioJect. No Serious Adverse Event (SAE) was reported during the study. At the end of the study all participants were considered immunized against rabies and no significant difference in humoral response was observed between the 3 studied routes. 2017 The Authors. Published by Elsevier Ltd. This is anopenaccess article under the CCBY-NC-ND license (http://creativecommons.org/licenses/by-nc-nd/4.0/).
微针注射过程中的输注压力和疼痛为人类受试者的皮肤。
影响因子：
14
作者：
Gupta, Jyoti;Park, Sohyun S.;Bondy, Brian;Felner, Eric I.;Prausnitz, Mark R.
通讯作者：
Prausnitz, Mark R.
影响因子：
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作者：
Prausnitz, Mark R;Mikszta, John A;Cormier, Michel;Andrianov, Alexander K
通讯作者：
Andrianov, Alexander K