A hepatitis B vaccine formulated with a novel adjuvant system

A hepatitis B vaccine formulated with a novel adjuvant system
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DOI:
10.1016/s0264-410x(99)00566-6
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发表时间:
2000-04-14
期刊:
影响因子:
5.5
通讯作者:
Thoelen, S
Thoelen, S
中科院分区:
医学3区
文献类型:
--
作者:
Ambrosch, F;Wiedermann, G;Thoelen, S

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虽然超过95%的接种人群对目前许可的B型肝炎疫苗有反应,但发现一些群体的反应较低。脂质A作为佐剂,通过其激活巨噬细胞的能力,可能改善体液以及细胞免疫应答。因此,我们评估了具有新佐剂系统SBAS 4的B型肝炎疫苗的概况。招募了150名年轻人并随机分为三组:一组接受SBAS 4 B型肝炎疫苗,第二组接受Engerix-B(TM)疫苗,第三组接受a型B型肝炎疫苗,其替代配方为明矾。在0和6个月时接种疫苗。疫苗耐受性良好。在第7个月,所有接种者都得到了保护,但两组之间的GMT存在显著差异:SBAS 4组为13,271 mIU/ml,而SBAS 4组为1203和1823 mIU/ml。因此,与含有相同抗原的其他疫苗相比,具有新佐剂系统的B肝炎疫苗具有更高的免疫原性,并且可能适合于两剂方案。(C)2000爱思唯尔科技有限公司版权所有。
Although more than 95% of the vaccinated population responds to the currently licensed vaccines against hepatitis B, some groups were found to be low responders. Lipid A as adjuvant, through its ability to activate macrophages, might improve humoral as well as cellular immune response. Therefore we evaluated the profile of a hepatitis B vaccine with the new adjuvant system SBAS4. 150 young adults were enrolled and randomized into three groups: one received the SBAS4 hepatitis B vaccine, the second Engerix-B(TM) and the third a hepatitis B vaccine with an alternative formulation on alum. Vaccinations were at 0 and 6 months. The vaccine was well tolerated. At month 7 all vaccinees were protected but with significant differences in GMTs between groups: 13,271 mIU/ml for the SBAS4 group versus 1203 and 1823 mIU/ml. Hence the hepatitis B vaccine with the new adjuvant system is more immunogenic compared to the other vaccines containing the same antigen and could be suitable for a two dose schedule. (C) 2000 Elsevier Science Ltd. All rights reserved.