Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults
Safety and efficacy of a novel microneedle device for dose sparing intradermal influenza vaccination in healthy adults
复制标题
DOI：
10.1016/j.vaccine.2008.10.077
复制
发表时间：
2009-01-14
期刊：
影响因子：
5.5
通讯作者：
Levin, Yotam
中科院分区：
文献类型：
--
作者：
Van Damme, Pierre;Oosterhuis-Kafeja, Froukje;Levin, Yotam
背景：皮内疫苗递送已被证明可以用低疫苗剂量诱导良好的免疫反应。专门针对皮肤的药物输送技术可能会使皮内疫苗接种变得更容易。方法：我们对 180 名打算治疗的健康成年人进行了一项前瞻性随机试验。研究目的是评估使用新型微针装置 (Micronjet) 注射的低剂量皮内 (ID) 流感疫苗的安全性和免疫原性。该装置取代了传统的针头，专为皮内注射而设计。受试者被随机分配接受使用传统针头肌肉注射的全剂量标准流感疫苗（每株含 15 μg 血凝素）（IM 组）、使用 Micronjet 进行的中剂量皮内注射（每株 6 μg 血凝素）（ID2 组）或低剂量皮内注射（每株含 3 μg 血凝素）。与 Micronjet（ID1 组）一起交付。所有注射均使用针对 2006/2007 流感季节的市售流感疫苗（GSK Biologicals 生产的 alpha-RIX(R)）。在 42 天内记录了不良事件。通过血凝抑制 (HAI) 抗体滴度的变化以及比较研究组之间的几何平均滴度 (GMT)、血清转化率和血清保护率来评估免疫原性。 结果：皮内接种疫苗后局部反应明显更频繁，但性质轻微且短暂。注射后21天，H1N1毒株的ID1、ID2和IM组的GMT倍数增加分别为22.18和22； H3N2 毒株为 9、9 和 16，B 毒株为 9、13 和 11。所有研究组均完全满足季节性流感疫苗重新许可的 CPMP 标准。结论：使用微针皮内注射低剂量流感疫苗引起的免疫原性反应与全剂量肌肉注射疫苗引起的免疫原性反应相似。本研究中使用的微针注射装置被证明是有效、安全、可靠的。 (C) 2008 年，爱思唯尔有限公司出版。
Background: Intradermal vaccine delivery has been shown to induce good immune responses with low vaccine doses. Technologies for drug-delivery which specifically target the skin may render intradermal vaccination more accessible.Methods: We conducted a prospective, randomized trial in 180 intended-to-treat healthy adults. Study objectives were to evaluate the safety and immunogenicity of low-dose intradermal (ID) influenza vaccines delivered using a novel microneedle device (Micronjet). This device replaces a conventional needle, and is designed specifically for intradermal delivery.Subjects were randomly assigned to receive either the full-dose standard flu shot (containing 15 mu g hemagglutinin per strain) delivered intramuscularly using a conventional needle (IM group), a medium dose intradermal injection (6 mu g hemagglutinin per strain) delivered with the Micronjet (ID2 group), or a low-dose intradermal injection (3 mu g hemagglutinin per strain) delivered with the Micronjet(ID1 group). A marketed influenza vaccine for the 2006/2007 influenza season (alpha-RIX(R) by GSK Biologicals) was used for all injections.Adverse events were recorded over a 42-day period. Immunogenicity was evaluated by changes in hemagglutination inhibition (HAI) antibody titer, and by comparing geometric mean titers (GMTs), seroconversion, and seroprotection rates between the study groups.Results: Local reactions were significantly more frequent following intradermal vaccination, but were mild and transient in nature. At 21 days after injection, GMT fold increase was 22.18 and 22 in the ID1, ID2 and IM groups respectively for the H1N1 strain; 9, 9 and 16 for the H3N2 strain and 9, 13 and 11 for strain B. The CPMP criteria for re-licensure of seasonal influenza vaccines were met in full for all study groups.Conclusions: Low-dose influenza vaccines delivered intradermally using microneedles elicited immunogenic responses similar to those elicited by the full-dose intramuscular vaccination. The microneedle injection device used in this study was found to be effective, safe, and reliable. (C) 2008 Published by Elsevier Ltd.