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[摘要]
目的 对流感病毒H7N9型裂解疫苗进行动物局部安全性评价。方法 家兔肌肉刺激试验:家兔后肢股四头肌im 0.5 mL流感病毒H7N9型裂解疫苗,每天给药1次,连续给药2 d,末次给药后48 h和第25天对注射部位进行肉眼和病理组织学检查。豚鼠全身主动过敏试验:豚鼠后肢隔日im 0.5 mL流感病毒H7N9型裂解疫苗,连续注射3次,于末次致敏后第14天iv给予1.0 mL的流感病毒H7N9型裂解疫苗进行激发,观察豚鼠30 min内是否出现过敏反应。急性毒性试验:小鼠后肢im 0.2 mL流感病毒H7N9型裂解疫苗,给药1次后观察小鼠的不良反应情况。结果 流感病毒H7N9型裂解疫苗可导致注射部位肌肉出现局灶性炎细胞浸润,肌间质细胞增生,条索状化脓灶,停药25 d后,上述病变消失。流感病毒H7N9型裂解疫苗豚鼠过敏反应发生率为67%,25 min内恢复正常,过敏反应评价为弱阳性到阳性;小鼠急性毒性试验未见异常。结论 流感病毒H7N9型裂解疫苗安全性良好,不影响其临床使用。
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[Abstract]
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.
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