Vescovo Paul, Rettby Nils, Ramaniraka Nirinarilala, Liberman Julie, Hart Karen, Cachemaille Astrid, Piveteau Laurent-Dominique, Zanoni Reto, Bart Pierre-Alexandre, Pantaleo Giuseppe
Debiotech SA, Lausanne, Switzerland.
Vaccine and Immunotherapy Center, Centre Hospitalier Universitaire Vaudois (CHUV), Lausanne, Switzerland.
Vaccine. 2017 Mar 27;35(14):1782-1788. doi: 10.1016/j.vaccine.2016.09.069.
In a single-center study, 66 healthy volunteers aged between 18 and 50years 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 30min 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.
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为三组，采用三种不同的注射途径接种狂犬病疫苗：使用DebioJect™进行皮内注射（IDJ）、使用传统针头进行标准皮内注射（IDS，也称为曼托试验法）以及使用传统针头进行肌肉注射（IM）。在第0天、第7天和第28天接种“巴斯德狂犬病疫苗”和生理盐水（0.9%氯化钠溶液）。两种皮内注射途径的抗原剂量均为肌肉注射剂量的1/5。将IDJ的耐受性、安全性和诱导的免疫原性与IDS和IM途径进行比较。在每次接种疫苗时，于进针时和注射产品时评估疼痛程度。每次接种疫苗后，每天记录主动不良事件（SolAE）以及包括疼痛、发红和瘙痒在内的局部反应原性症状。在整个研究期间记录不良事件（AE）。通过使用快速荧光灶抑制试验（RFFIT）评估狂犬病病毒中和抗体（VNA）滴度来测量体液免疫反应。结果表明，DebioJect™是一种安全、可靠且有效的装置。与IDS和IM相比，IDJ在进针时和疫苗注射时的疼痛明显减轻。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，只是IDJ注射生理盐水后30分钟时发红更明显。没有全身性SolAE被认为与DebioJect™和传统针头有关。没有AE被认为与DebioJect™有关。在研究期间未报告严重不良事件（SAE）。在研究结束时，所有参与者均被认为已接种狂犬病疫苗，并且在三种研究途径之间未观察到体液反应的显著差异。
