Department of Pharmacy, Women's Hospital, Zhejiang University, Hangzhou, China.
AAPS J. 2010 Dec;12(4):519-24. doi: 10.1208/s12248-010-9213-1. Epub 2010 Jun 25.
Hepatitis B vaccination typically requires a multi-dose administration protocol over a course of 3-6 months. Aiming at developing a single-shot formulation for hepatitis B vaccine (hepatitis B surface antigen (HBsAg)), a novel vaccine delivery system, the composite microspheres of alginate-chitosan-poly(lactic-co-glycolic acid) (PLGA), was synthesized by a two-step preparation. The composite microspheres showed distinct advantages over the conventional PLGA microspheres in aspects of the high loading capacity and the elimination of lyophilizing process. The loading capacity of the composite microspheres was about seven times higher than those in the conventional PLGA microspheres, due to the protein-friendly microenvironment created by the hydrophilic alginate-chitosan cores of the composite microspheres. This vaccine delivery system was shown to be able to induce robust immune responses by single injection and display no significant difference in HBsAg-specific antibody levels compared to the double-injection method.
乙肝疫苗接种通常需要在 3-6 个月的时间内进行多剂量给药方案。为了开发乙肝疫苗（乙肝表面抗原（HBsAg））的单针制剂，一种新型疫苗递送系统，通过两步法制备了海藻酸钠-壳聚糖-聚（乳酸-共-乙醇酸）（PLGA）的复合微球。与传统的 PLGA 微球相比，复合微球在高载药量和消除冻干过程方面具有明显的优势。由于复合微球的亲水性海藻酸钠-壳聚糖核形成了有利于蛋白质的微环境，因此复合微球的载药量约为传统 PLGA 微球的七倍。该疫苗递送系统通过单次注射即可诱导出强烈的免疫反应，并且与双注射方法相比，HBsAg 特异性抗体水平没有显著差异。
