Tsals Izrail, Jarrahian Courtney, Snyder Fred E, Saganic Laura, Saxon Eugene, Zehrung Darin, Zimmerman Glen, Papania Mark, Klaff Leslie
SID Technologies, 51 Rittenhouse Cir., Newtown, PA 18940, USA.
PATH, 2201 Westlake Avenue, Suite 200, Seattle, WA 98121, USA.
Vaccine. 2015 Sep 8;33(37):4705-11. doi: 10.1016/j.vaccine.2015.04.095. Epub 2015 May 9.
Although the number of vaccines and diagnostic tests currently delivered intradermally is limited, this route of administration offers potential advantages due to the high concentration of antigen-presenting cells in the skin. One factor which may in part be limiting development and use of intradermal (ID) administration is concern about the ease and reliability of the needle and syringe-based Mantoux technique. A phase I clinical study was conducted to evaluate two ID adapters that have been developed as injection-delivery aids to increase the safety, simplicity, and reliability of ID injection: a prototype autodisable, intradermal (ADID) adapter for autodisable (AD) syringes, and a marketed side-merge adapter (SMA). Thirty healthy adult volunteers each received six injections of 0.1 mL of sterile saline solution. Each adapter was used to give injections into the upper deltoid, forearm, and suprascapular regions of each volunteer. The needle-bevel orientation during injection was random. Injection performance was determined by measuring wheal size and fluid leakage. Wheals were similar in size for the ADID adapter (mean 9.9 ± 0.17 mm) and SMA (mean 9.8 ± 0.15 mm). In all of the injections completed with the SMA, and 98% of those completed with the ADID, fluid leakage was less than 10% of the intended injection volume. Minor skin abrasions were the only adverse events. Based on self-reporting of pain, injections were well tolerated (mean pain score of 2 on a 0-10 scale). ID delivery using the SMA and ADID adapters appears safe and effective.
尽管目前皮内注射的疫苗和诊断测试数量有限，但由于皮肤中抗原呈递细胞浓度高，这种给药途径具有潜在优势。可能在一定程度上限制皮内（ID）给药发展和使用的一个因素是对基于针头和注射器的曼托试验技术的简便性和可靠性的担忧。进行了一项I期临床研究，以评估两种已开发用作注射给药辅助工具的ID适配器，以提高ID注射的安全性、简便性和可靠性：一种用于自动销毁（AD）注射器的原型自动销毁皮内（ADID）适配器，以及一种市售的侧合并适配器（SMA）。30名健康成年志愿者每人接受6次0.1mL无菌盐溶液的注射。每个适配器用于在每个志愿者的上臂三角肌、前臂和肩胛上区域进行注射。注射期间针头斜面方向是随机的。通过测量风团大小和液体渗漏来确定注射性能。ADID适配器的风团大小（平均9.9±0.17mm）与SMA的风团大小（平均9.8±0.15mm）相似。在所有用SMA完成的注射中，以及98%用ADID完成的注射中，液体渗漏小于预期注射体积的10%。轻微皮肤擦伤是唯一的不良事件。根据疼痛的自我报告，注射耐受性良好（0至10分制的平均疼痛评分为2分）。使用SMA和ADID适配器进行ID给药似乎是安全有效的。
