日本血吸虫双价DNA疫苗肌肉刺激和全身过敏试验

Muscular stimulation and systemic anaphylaxis test of Schistosoma japonicum bivalent DNA vaccine

目的观察日本血吸虫双价DNA疫苗对家兔肌肉注射所产生的刺激反应和豚鼠的全身过敏反应,评价其安全性。方法家兔4只,雌雄各半,采用自身对照,左侧股四头肌注射日本血吸虫双价DNA疫苗,右侧注射生理盐水,观察注射部位肌肉的刺激反应,并进行病理组织学检查;豚鼠24只,随机分为4组,日本血吸虫双价DNA疫苗组(致敏剂量0.5mg/只,激发剂量1mg/只)、空白质粒对照组(致敏剂量0.5mg/只,激发剂量1mg/只)、生理盐水对照组和10%人血白蛋白阳性对照组,进行全身过敏试验。结果日本血吸虫双价DNA疫苗对家兔肌肉局部刺激仅见注射部位轻度充血,未发现肌肉组织的变性和坏死;对豚鼠无过敏反应发生,10%人血白蛋白阳性对照组出现明显的过敏反应。结论日本血吸虫双价DNA疫苗对家兔肌肉无刺激作用,对豚鼠也无过敏反应,预期临床应用安全。

Objective To investigate the muscular stimulation response on rabbits and systemic anaphylaxis on guinea pigs of Schistosoma japonicum bivalent DNA vaccine. Methods Two male and two female rabbits were tested for muscular stimulation with the intra-individual left/right self comparison method, to observe the muscle stimulation responses and histopathologic changes on the injection sites; 24 guniea pigs were randomly divided into 4 groups （ Schistosomajaponicum bivalent DNA vaccine group, pVIVO2 group, physiological saline group, 10% human serum albumin group） to test for systemic anaphylaxis. Results There was light hyperaemia and no degeneration/necrosis on the injeetion sites of rabbits; there was no systemic anaphylaxis in the vaccine, pVIVO2, physiological saline groups and apparent anaphylaxis in the 10% human serum albumin group of guniea pigs. Conclusions There are no muscular stimulation and systemic anaphylaxis with Schistosoma japonicum bivalent DNA vaccine, and the bivalent DNA vaccine may be safe in clinical trials.