冻干口服霍乱rBS—WC菌苗安全及保护效果评价的小鼠模型探讨

本文仿照人口服免疫程序用小鼠为模型对冻干口服霍乱ｒＢＳ－ＷＣ菌苗制品进行了安全及保护率评价。给ＫＭ小鼠口服三种不同剂量的ｒＢＳ－ＷＣ菌苗后，无发病，无体重减轻，无死亡现象，表明该菌苗安全，无毒副作用。免疫组与安慰剂组小鼠用肠结扎攻毒试验评价保护效果，两组小鼠用吴江－２及滨－４３活菌攻击后，免疫组显示良好保护作用（Ｐ＜０．０５）。此法可以用于口服型ｒＢＳ－ＷＣ菌苗的评价，但也存在需要动物数较多，个体间差异较大，手术较麻烦的问题。

Investigation of Mouse Model to Assess Safty and Efficacy of Freeze-Dried Cholera rBS-WC Vaccine for Oral

A freeze-dried cholera rBS-WC vaeeine for oral has been developed, but there is not a rules about production and detection of it. In this paper, we mimic the oral immunization program in human to assess the safety and efficacy of rBS-WC vaccine in mouse. Aftar the KM mouse received three doses of above in each of three level, no mortality and no mortality and no loss of body weight appeared indicating our vaccineproduct is safety and no side effect. The protection against Vibrio Cholera Wujiang-2 and Bin-43of oral cholera vaccination was compared to the plaeebo (control) . The results of statistics assay (x2 assay) suggest that the difference between two groups is significant (p<0.05) .This method can be used to assess oral cholera vaccine such as rBS-WC and WC. But a lot of mice will be required in this method (at least 10 mice per group) and the operation on mouse is trouble. Furethemore, there is considerable intdividual difference.