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结核病是一种严重危害人类健康的重大传染病,由于BCG预防效果不佳,研制新型结核病疫苗迫在眉睫。研究开发新型结核病疫苗应根据机体抗结核杆菌感染的免疫应答特点、结合BCG的不足来开展。新型结核病疫苗主要分为三类:重组BCG或重组结核菌;重组痘病毒或重组腺病毒载体疫苗;蛋白抗原亚单位或重组融合蛋白抗原亚单位疫苗。由于蛋白亚单位疫苗可以不受机体已被分枝杆菌刺激的影响,能特异性地诱导CD4+Th1细胞和CD8+细胞毒性T细胞活化,并且使用安全性好,而备受研究者的青睐。目前主要是以BCG或重组BCG初次免疫,然后选择亚单位疫苗加强免疫作为结核病疫苗序贯免疫策略。然而,单个蛋白制成亚单位疫苗,其免疫效果有限,因此将多个具有保护效果的抗原或多肽表达成融合蛋白,联合适当的佐剂,制成融合蛋白亚单位疫苗。目前,已有一些融合蛋白亚单位疫苗进入临床试验阶段,更多的融合蛋白正处于研究阶段。
Tuberculosis is a serious infectious disease that seriously endangers human health. Because of the poor preventive effect of BCG, it is imminent to develop a new TB vaccine. Research and development of a new type of tuberculosis vaccine should be based on the characteristics of the body’s immune response to anti-TB infection, combined with the lack of BCG to carry out. New TB vaccines fall into three broad categories: recombinant BCG or recombinant TB; recombinant pox or recombinant adenovirus vectors; protein antigen subunits or recombinant fusion protein subunit vaccines. Since subunit vaccines can specifically stimulate the activation of CD4 + Th1 cells and CD8 + cytotoxic T cells without being affected by mycobacteria, the use of protein subunit vaccines has attracted researchers’ interest because of their safety and safety. The current primary immunization with BCG or recombinant BCG, and then choose subunit vaccine to strengthen immunity as a sequential immunization strategy for tuberculosis vaccine. However, the subunit vaccine produced by a single protein has a limited immunological effect, so multiple antigens or polypeptides having protective effects are expressed as fusion proteins, and a suitable adjuvant is combined to form a fusion protein subunit vaccine. At present, some fusion protein subunit vaccines have entered the clinical trial phase, and more of the fusion proteins are in the research stage.