冻干人用狂犬病疫苗(Vero细胞)在豚鼠体内主动过敏反应试验

Active anaphylactic reaction test on freeze-dried rabies vaccine for human use(Vero cells)in guinea pigs

目的观察冻干人用狂犬病疫苗(Vero细胞)在豚鼠体内主动过敏反应情况。方法将18只雌性豚鼠随机分为3组:阴性对照组(给予0.9%氯化钠注射液,致敏剂量为0.5 ml/只,激发剂量为1 ml/只)、阳性对照组[给予人血白蛋白,致敏剂量为20 mg/(0.5 ml·只),激发剂量为40 mg/(1 ml·只)]、供试品组[给予冻干人用狂犬病疫苗(Vero细胞),致敏剂量为1剂/(0.5 ml·只),激发剂量为2剂/(1 ml·只)],每组6只。致敏试验均经豚鼠后肢肌肉多点注射,隔日免疫1次,共免疫3次;末次致敏后14 d进行激发试验,均经豚鼠足部静脉注射给药,观察各组豚鼠的一般临床症状、体重及全身过敏反应症状。结果致敏期间,所有动物均未见异常表现。试验期间,各组豚鼠体重均呈增长趋势。静脉激发后,阴性对照组豚鼠未见过敏反应症状,过敏反应呈阴性;阳性对照组过敏反应呈阳性至极强阳性;供试品组动物过敏反应呈弱阳性至阳性。结论冻干人用狂犬病疫苗(Vero细胞)安全性良好,为其临床使用提供了实验依据。

Objective To observe the active anaphylactic reaction caused by freeze-dried rabies vaccine for human use（Vero cells） in guinea pigs. Methods Eighteen female guinea pigs were randomly divided into three groups, i. e.negative control（0. 9% sodium chloride solution for injection, 0. 5 ml per guinea pig for sensitization and 1 ml per guinea pig for excitation）, positive control（human serum albumin, 20 mg / 0. 5 ml per guinea pig for sensitization and40 mg / 1 ml per guinea pig for excitation） and test[freeze-dried rabies vaccine for human use（Vero cells）, one dose（0. 5 ml per guinea pig）for sensitization and two doses（1 ml per guinea pig）for excitation], six for each. All the guinea pigs were injected i. m. in several sites every other day for 3 times for sensitization, and injected i. v. 14 d after the last sensitization for excitation. The general symptoms, bodyweights and systemic anaphylactic reactions in various groups were observed. Results No any abnormalities were observed during sensitization, while all the bodyweights of guinea pigs showed increasing tendencies. After excitation, no anaphylactic reactions were observed in negative control group, and the results of anaphylactic reaction test were negative. However, the results were positive or strong positive in positive control group, and weak positive or positive in test group. Conclusion Freeze-dried rabies vaccine for human use（Vero cells）showed high safety, which provided an experimental basis for its clinical application.