QIMR Berghofer Medical Research Institute, Queensland, Australia; Q-Pharm Pty Ltd, Herston, Australia; Department of Medicine and Infectious Diseases, Mater Hospital and Mater Research, Queensland, Australia; The University of Queensland, Queensland, Australia.
Q-Pharm Pty Ltd, Herston, Australia.
Vaccine. 2017 Dec 4;35(48 Pt B):6676-6684. doi: 10.1016/j.vaccine.2017.10.021. Epub 2017 Oct 23.
Most vaccinations are performed by intramuscular injection with a needle and syringe. However, this method is not ideal due to limitations, such as the risk of needle-stick injury, the requirement for trained personnel to give injections and the need to reconstitute lyophilized vaccines. Therefore, we tested an alternative delivery technology that overcomes the problems with needle and syringe. The Nanopatch™ is an array of 10,000 silicon micro-projections per cm that can be dry-coated with vaccine for skin delivery. The high number and density of micro-projections means that high velocity application is required to achieve consistent skin penetration. Before clinically testing a vaccine Nanopatch, this study tests the safety, tolerability and acceptability/utility of uncoated and excipient-coated Nanopatches in healthy adults. Nanopatches were applied to skin of the upper arm and volar forearm and left in contact with the skin for two minutes before removal. The application sites were assessed for local skin response over 28 days. Acceptability interviews were also performed. No unexpected adverse events directly related to the Nanopatch application were reported. All applications of the Nanopatch resulted in an expected erythema response which faded between days 3 and 7. In some subjects, some skin discolouration was visible for several days or up to 3 weeks after application. The majority (83%) of subjects reported a preference for the Nanopatch compared to the needle and syringe and found the application process to be simple and acceptable. On a pain scale from 0 to 10, 78% of applications were scored "0" (no pain) with the average scores for less than 1. The results from this study demonstrate the feasibility of the Nanopatch to improve vaccination by showing that application of the product without vaccine to human skin is safe, tolerable and preferred to needle and syringe administration. Clinical trial registry ID: ACTRN1261500083549.
大多数疫苗接种都是通过肌肉内注射针和注射器进行的。然而，由于存在一些限制，如针刺伤的风险、需要经过培训的人员进行注射以及需要对冻干疫苗进行复溶等，这种方法并不理想。因此，我们测试了一种替代的传递技术，该技术克服了针和注射器带来的问题。Nanopatch™是一种由每平方厘米 10000 个硅微针组成的阵列，可以用疫苗进行干涂敷，从而实现皮肤传递。由于微针的数量和密度很高，因此需要高速应用才能实现一致的皮肤穿透。在对疫苗 Nanopatch 进行临床测试之前，本研究测试了未涂覆和涂覆赋形剂的 Nanopatch 在健康成年人中的安全性、耐受性和可接受性/实用性。将 Nanopatch 应用于上臂和掌侧前臂的皮肤表面，然后保持与皮肤接触两分钟，再将其取下。在 28 天内评估应用部位的局部皮肤反应。还进行了可接受性访谈。未报告与 Nanopatch 应用直接相关的任何意外不良事件。所有 Nanopatch 的应用都会导致预期的红斑反应，该反应在第 3 天至第 7 天之间逐渐消退。在一些受试者中，一些皮肤变色在应用后几天或长达 3 周内可见。大多数（83%）受试者表示更喜欢 Nanopatch 而不是针和注射器，并且发现应用过程简单且可接受。在 0 到 10 的疼痛量表上，78%的应用评分为“0”（无疼痛），平均得分小于 1。本研究的结果表明，通过证明在人类皮肤上应用不含疫苗的产品是安全、耐受且优于针和注射器给药，该产品具有改善疫苗接种的可行性。临床试验注册号：ACTRN1261500083549。
