H5N1亚型禽流感油佐剂疫苗安全性试验研究

摘要

通过对H5N1亚型禽流感油佐剂疫苗的急性毒性试验、眼结膜刺激试验、肌肉刺激试验与溶血试验研究，评价其安全性。急性毒性试验：取AA+肉鸡70只，随机分成7组，设为高剂量疫苗组与佐剂组，中剂量疫苗组与佐剂组，低剂量疫苗组与佐剂组，空白对照组。眼结膜刺激试验：取兔12只，随机分成2组，为疫苗组和佐剂组，采用自身对照法，观察兔眼的情况。肌肉刺激试验：取兔8只，随机分成2组，为疫苗组和佐剂组，采用自身对照法，观察注射部位肌肉的刺激反应。溶血试验：取兔1只，心脏采血5 mL，制成2％红细胞混悬液进行溶血试验。急性毒性试验结果未测出LD50，测定20倍临床剂量为其最大给药量，说明临床使用剂量安全。眼结膜刺激试验、肌肉刺激试验及溶血试验的结果表明，疫苗的刺激性较弱，没有溶血性，故可采用注射法给药。%Through acute toxicity test, eye irritation test, muscular stimulation test and haematolysis test, it evaluated the safety of the H5N1 subtype avian influenza oil-adjuvant vaccine. Total to chickens were divided into seven groups in acute toxic test: high dose vaccine group and adjuvant group, middle dose vaccine group and adjuvant group, low dose vaccine group and adjuvant group, and blank control group. In rabbits eye irritation test, twelve rabbits were divided into vaccine group and adjuvant group, using own control to observe the eyes. Eight rabbits were used to do muscular stimulation experiments. And prepared 2% rabbit erythrocyte suspension in haematolysis test. In acute toxicity, the LD50 can not be calculated and 20 times clinical dose was the maximum. From the results of eye irritation test, muscular stimulation test and haematolysis test, the vaccine has lower irritation and less haematolysis by injection.