目的 對流感病毒H7N9型裂解疫苗進行動物局部安全性評價。方法 家兔肌肉刺激試驗:家兔后肢股四頭肌im 0.5 mL流感病毒H7N9型裂解疫苗,每天給藥1次,連續(xù)給藥2 d,末次給藥后48 h和第25天對注射部位進行肉眼和病理組織學檢查。豚鼠全身主動過敏試驗:豚鼠后肢隔日im 0.5 mL流感病毒H7N9型裂解疫苗,連續(xù)注射3次,于末次致敏后第14天iv給予1.0 mL的流感病毒H7N9型裂解疫苗進行激發(fā),觀察豚鼠30 min內(nèi)是否出現(xiàn)過敏反應。急性毒性試驗:小鼠后肢im 0.2 mL流感病毒H7N9型裂解疫苗,給藥1次后觀察小鼠的不良反應情況。結(jié)果 流感病毒H7N9型裂解疫苗可導致注射部位肌肉出現(xiàn)局灶性炎細胞浸潤,肌間質(zhì)細胞增生,條索狀化膿灶,停藥25 d后,上述病變消失。流感病毒H7N9型裂解疫苗豚鼠過敏反應發(fā)生率為67%,25 min內(nèi)恢復正常,過敏反應評價為弱陽性到陽性;小鼠急性毒性試驗未見異常。結(jié)論 流感病毒H7N9型裂解疫苗安全性良好,不影響其臨床使用。

Objective To evaluate the local safety of H7N9 Influenza Split Vaccine in animals. Methods Rabbits were im injected with H7N9 Influenza Split Vaccine (0.5 mL, once daily continuously for 2 d), and macrography and pathological examination of injection site was conducted after 48 h and 25 d of the last administration. Guinea pigs were im injected with H7N9 Influenza Split Vaccine (0.5 mL) every other day for three times successively, and on day 14 after the last sensitization, H7N9 Influenza Split Vaccine (1.0 mL) was iv administered to observe whether the allergic reaction appeared within 30 min. Mice were im administered once with H7N9 Influenza Split Vaccine (0.2 mL) and observed continuously for 14 d for acute toxical symptoms. Results Pathological changes such as focal inflammatory cell infiltration, muscle interstitial cell hyperplasia and hemorrhage, and funicular suppurative focus were observed in the injection sites of rabbits, and disappeared on day 25 after stopping administration. The incidence of anaphylactic reactions of the vaccine in Guinea pigs was 67% and allergic reactions were evaluated as extremely mild or mild positive, and the animals with reactions were recovered to normal within 25 min. No abnormality was observed in acute toxicity test. Conclusion H7N9 Influenza Split Vaccine is safe and suitable for clinical application.