对重组pcDNA3.1+/Ag85A DNA阳离子脂质体疫苗的安全性进行初步评价,为临床经口接种DNA疫苗提供理论和实验依据.取质粒存在最丰富的2个部位,即脾、小肠,提取基因组中DNA,并以此为模板进行PCR扩增.分析质粒重组体是否与基因组DNA整合,同时将受试动物实验组与对照组在受试期间体重、食量、一般活动等方面比较；受试小鼠脏器重量与对照组进行比较.结果显示,质粒重组体并未与基因组DNA整合,同时受试动物实验组与对照组之间,无论受试期还是恢复期之间体重、食量、一般活动等方面未见明显改变.受试小鼠脏器重量与对照组相比,无明显差别,从而证明脂质体pcDNA3.1+/Ag85A DNA未与宿主基因组整合,间接说明pcDNA3.1 +/Ag85A DNA疫苗对免疫动物并没有潜在的致癌作用.%The initial security verification of recombinant pcDNA3. 1+/ Ag85A DNA cationic liposome vaccine was conducted to provide theoretical and experimental basis for clinical oral DNA vaccine inoculation. The most abundant plasmids existing organ, I. E. Spleen and small intestine were extracted for genomic DNA, and carried out PCR amplification using the DNA as a template, the recombinant plasmid and genomic DNA integration were analyzed. While the weight, food intake, general activity, organ weights, etc. Of the tested animals during the testing period were compared with the experimental group and control group. The results showed that liposome pcDNA3. 1+/ Ag85A DNA did not integrate with the host genome, while the weight, food intake, general activity, organ weights did not change significantly no matter they were in the testing period or in the recovering period, thus proved that pcDNA3. 1 V Ag85A DNA did not integrated with the genome of the host implying that pcDNA3. 1+/ Ag85A DNA vaccine had no potential carcinogenic effects on immunized animals.
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