Unit R&D, Netherlands Vaccine Institute, Bilthoven, The Netherlands.
J Control Release. 2010 Oct 15;147(2):211-7. doi: 10.1016/j.jconrel.2010.06.028. Epub 2010 Jul 8.
An alternative vaccine delivery system for needle injections is the Bioneedle. Hepatitis B surface antigen (HBsAg) was formulated with Bioneedles. Three formulations were used: plain antigen, HBsAg adjuvated with aluminum hydroxide and HBsAg with LPS-derived lpxL1. Bioneedles with HBsAg-lpxL1 were the most stable and the most immunogenic formulations. The conventional liquid alum adjuvated vaccine lost 40% of its antigenicity after 1week at 50°C whereas the HBsAg-lpxL1 Bioneedles showed no significant decrease after 3 weeks at 50°C. In vivo studies revealed that the HBsAg-lpxL1 Bioneedle formulations induced comparable IgG titers as conventional liquid formulations after 2 immunizations, but higher IgG2a titers were found already after 1 immunization. The in vivo and in vitro studies showed that the Bioneedle is an attractive alternative for needle injections of HBsAg vaccines.
Bioneedle 是一种替代针剂注射的新型疫苗输送系统。乙型肝炎表面抗原 (HBsAg) 与 Bioneedle 联合制成疫苗。共使用了三种制剂：普通抗原、佐剂氢氧化铝增强的 HBsAg 和含有 LPS 衍生的 lpxL1 的 HBsAg。含 HBsAg-lpxL1 的 Bioneedle 是最稳定和最具免疫原性的制剂。传统的液体铝佐剂疫苗在 50°C 下放置一周后失去了 40%的抗原性，而 HBsAg-lpxL1 Bioneedle 在 50°C 下放置 3 周后没有明显减少。体内研究表明，HBsAg-lpxL1 Bioneedle 制剂在进行 2 次免疫接种后，可诱导与传统液体制剂相当的 IgG 滴度，但在进行 1 次免疫接种后即可发现更高的 IgG2a 滴度。体内和体外研究表明，Bioneedle 是 HBsAg 疫苗针剂注射的一种有吸引力的替代方案。
