[关键词]
[摘要]
目的 评价重组三价人乳头瘤病毒(HPV)疫苗的急性毒性。方法 将Wistar大鼠随机分成2组:阴性对照组和HPV疫苗组,每组20只,HPV疫苗组单次sc 3倍人用剂量(1.5 mL)HPV疫苗,阴性对照组注射等体积的生理盐水。观察动物临床状态;检测动物体质量变化;给药后第15天,解剖大鼠,进行大体病理学检查。结果 动物单次给药大剂量HPV疫苗后,临床症状均未见明显异常;与对照组比较,给药组动物体质量增长未见显著性差异;病理学检查未见与供试品相关的明显异常。结论 Wistar大鼠单次sc重组三价HPV疫苗总体耐受性良好,未见明显毒性反应,为进一步临床前评价HPV疫苗的安全性奠定了基础。
[Key word]
[Abstract]
objective To evaluate the acute toxicity of recombinant trivalent human papillomavirus (HPV) vaccines.Methods Wistar rats were randomly divided into negative control and HPV groups with 20 rats in each group. Rats in HPV groups were sc administered with a single-dose of 1.5 mL of HPV vaccines (three times of human dose/each rat), while rats in negative control group were given equal volume of saline. The clinical state of animals was observed, and the body mass changes were detected. Rats were dissected after 15 d of treatment and examined by gross pathology.Results Following a single injection with high-dose HPV vaccines, there were not obvious abnormalities in clinical symptom. Compared with negative control group, the body weight of rats from HPV vaccines-treated group had no significant difference. No obvious macro-pathological change was found in all animals.Conclusion Single sc injection with recombinant trivalent HPV vaccines is well tolerated and no obvious toxicological change is found in Wistar rats. These results will facilitate further preclinical safety studies of HPV vaccines.
[中图分类号]
[基金项目]
“重大新药创制”科技重大专项(2015ZX09501007-004)