Vaccines Research, Novartis Vaccines, Cambridge, Massachusetts, USA.
J Pharm Sci. 2012 Mar;101(3):1021-7. doi: 10.1002/jps.23019. Epub 2011 Dec 20.
Microneedle patches are gaining increasing attention as an alternative approach for the delivery of vaccines. In this study, a licensed seasonal influenza vaccine from 2007 to 2008 was fabricated into dissolvable microneedles using TheraJect's microneedle technology (VaxMat). The tips of the microneedles were made of antigens mixed with trehalose and sodium carboxymethyl cellulose. The patches containing 15 μg per strain of the influenza antigen were characterized extensively to confirm the stability of the antigen following fabrication into microneedles. The presence of excipients and very low concentrations of the vaccine on the microneedle patches made it challenging to characterize using the conventional single radial immunodiffusion analysis. Novel techniques such as capture enzyme-linked immunosorbent assay and enzyme digestion followed by mass spectroscopy were used to characterize the antigens on the microneedle patches. The in vivo studies in mice upon microneedle administration show immunogenicity against monovalent H1N1 at doses 0.1 and 1 μg and trivalent vaccine at a dose of 1 μg. The initial data from the mouse studies is promising and indicates the potential use of microneedle technology for the delivery of influenza vaccine.
微针贴片作为疫苗传递的替代方法受到越来越多的关注。在这项研究中，使用 TheraJect 的微针技术（VaxMat）将 2007 年至 2008 年获得许可的季节性流感疫苗制成可溶解的微针。微针的尖端由与海藻糖和羧甲基纤维素钠混合的抗原制成。含有每株流感抗原 15μg 的贴片经过广泛的特性分析，以确认抗原在制成微针后仍保持稳定。由于微针贴片上存在赋形剂和极低浓度的疫苗，因此使用常规的单径向免疫扩散分析对其进行特性分析具有挑战性。因此，采用捕获酶联免疫吸附测定和酶消化后进行质谱分析等新技术来对微针贴片上的抗原进行特性分析。在小鼠的体内研究中，微针给药后对单价 H1N1 的免疫原性在 0.1 和 1μg 剂量以及三价疫苗 1μg 剂量下均有效果。来自小鼠研究的初步数据令人鼓舞，表明微针技术有潜力用于流感疫苗的传递。
