Global R&D, Baxter BioScience, Wagramer Str. 17-19, A-1221 Vienna, Austria.
Vaccine. 2011 Oct 6;29(43):7307-19. doi: 10.1016/j.vaccine.2011.07.089. Epub 2011 Aug 16.
The need for highly effective tick-borne encephalitis (TBE) vaccines has increased globally due to a variety of factors including climate, social, economic and demographic changes, which are thought to have promoted the expansion of the endemic region of TBE viruses. The first TBE vaccine, FSME-IMMUN Inject, was introduced in the 1970s and has been continually improved since then to enhance both its safety and immunogenicity. The current formulation was established in 2001 and is marketed as FSME-IMMUN. This review summarizes findings of the clinical development programme since 2001 regarding determination of the optimal dose, conventional and rapid vaccination schedules, vaccination in adults, the elderly and special patient populations, safety, immunogenicity, and immunopersistence in adults and children, comparison of FSME-IMMUN with another commercially available TBE vaccine as well as post-marketing vaccination outcome. This successful research programme demonstrated the strong immunogenicity and continued safety of the FSME-IMMUN vaccine, which is further confirmed by the performance reported under field conditions.
由于多种因素，包括气候、社会、经济和人口变化，全球对高效蜱传脑炎 (TBE) 疫苗的需求不断增加，这些因素被认为促进了 TBE 病毒地方性流行区的扩大。第一个 TBE 疫苗 FSME-IMMUN Inject 于 20 世纪 70 年代推出，此后不断改进，以提高其安全性和免疫原性。目前的配方于 2001 年确立，并以 FSME-IMMUN 销售。这篇综述总结了 2001 年以来关于确定最佳剂量、常规和快速接种时间表、成人、老年人和特殊人群接种、安全性、免疫原性以及成人和儿童的免疫持久性、FSME-IMMUN 与另一种市售 TBE 疫苗的比较以及上市后疫苗接种结果的临床开发计划的发现。这一成功的研究计划证明了 FSME-IMMUN 疫苗的强大免疫原性和持续安全性，而在现场条件下报告的性能进一步证实了这一点。
