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EcSf2a-2株是含有福氏志贺菌侵袭性质粒以及编码2a型福氏志贺菌脂多糖(LPS)的染色体基因的第二代大肠杆菌载体菌苗株,本试验在以色列细菌性痢疾流行区的士兵中就其安全性及免疫原性进行了研究。 采用双盲安慰剂对照试验。冻干菌苗服用前按预定剂量稀释。安慰剂为含有1%胰蛋白胨及不同含量的葡聚糖、庶糖及甘油的磷酸盐缓冲盐水。菌苗服用前后90分钟禁食禁水,预服120ml 1.3%的NaHCO_3溶液。60名志愿者接受菌苗(53名完成全程4剂服苗,间隔1周),59名接受安慰剂。服苗剂量为4.1×10~8和1.1×10~9菌落形成单位(cfu)。服苗后测定不良反应的发生率并在第2、4剂服苗后测定排苗率;通过限制性片段长度多态性(RFLP)分析、抗生素敏感性测定及噬菌体分型检测菌苗株的遗传稳定性;用ELISA检测血清抗体水平并结合抗体分泌细胞检测研究菌苗的免疫原性。
The EcSf2a-2 strain is a second-generation Escherichia coli vector vaccine strain that contains the invading plasmid of Shigella flexneri and the chromosomal gene encoding LPS of Type 2a. This test was performed on the bacillary dysentery in Israel The soldiers in the area studied their safety and immunogenicity. Double-blind placebo-controlled trial. Dilute the lyophilized bacterin in a predetermined dose before taking it. Placebo was phosphate-buffered saline with 1% tryptone and varying amounts of dextran, sucrose and glycerol. 90 minutes before and after taking the vaccine forbidden to ban water, pre-service 120ml 1.3% NaHCO_3 solution. Sixty volunteers received the vaccine (53 completed four doses of the vaccine, one week apart) and 59 received placebo. The vaccine dose was 4.1 × 10 ~ 8 and 1.1 × 10 ~ 9 colony forming units (cfu). The rate of adverse reactions was determined after taking the vaccine and the rate of the vaccine was measured after the second and fourth doses of the vaccine. The restriction fragment length polymorphism (RFLP) analysis was used to determine the antibiotic susceptibility and the phage typing Genetic stability was tested by ELISA. The level of serum antibody was detected by ELISA and the immunogenicity of the vaccine was tested by antibody-secreting cells assay.