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目的观察SD大鼠注射水痘减毒活疫苗(SV-1细胞)后可能出现的毒性反应、毒性反应的恢复情况及可能出现的延迟性毒性反应。方法将SD大鼠随机分为8组,1~4组(主试验组)分为阴性对照组(生理盐水,2.5 ml/只)、细胞基质对照组(SV-1细胞基质,2.5 ml/只)、疫苗低剂量组(水痘减毒活疫苗1剂)和疫苗高剂量组(水痘减毒活疫苗5剂),每组30只;5~8组(卫星组)分组同1~4组,每组10只。均经大鼠颈背部皮下单点注射,每2周注射1次,连续注射3次,末次免疫后6周为恢复期。试验期间进行一般临床观察、体重、食量、体温、眼科、血细胞计数、凝血功能、血液生化、免疫指标、大体解剖观察、主要脏器称重、组织病理学等检查。结果试验期间,主试验组各组动物一般状况良好,各项指标检测均未见有毒理学意义的规律性改变,且动物脏器重量均未见与疫苗相关的明显改变,各组织脏器大体解剖观察均未见明显与给药相关的毒性病理学改变,注射局部组织未见明显与疫苗相关的刺激性反应;卫星组大鼠免疫前血清抗体均为阴性,末次免疫后2周,阴性对照组和细胞基质组抗体检测结果均为阴性,低剂量组和高剂量组抗体阳转率100%,抗体几何平均滴度(GMT)分别为1∶73.5和1∶111.4,仅有部分大鼠可检测到分泌IFNγ的T淋巴细胞。结论水痘减毒活疫苗(SV-1细胞)经大鼠长期毒性试验未见明显毒性反应,初步证实该疫苗具有良好的安全性及有效性。
OBJECTIVE: To observe the possible toxic reactions, the recovery of toxic reactions and the possible delayed toxic reactions after SD attenuated live vaccine (SV-1 cells). Methods Sprague-Dawley rats were randomly divided into 8 groups. Group 1 to 4 (main experimental group) were divided into negative control group (2.5 ml / normal saline), matrix control group (SV-1 cell matrix, 2.5 ml / ), Vaccine low-dose group (live attenuated varicella vaccine 1) and vaccine high-dose group (varicella live attenuated vaccine 5), each group 30; 5 to 8 groups (satellite group) group with 1 to 4 groups, Each group of 10. Rats were injected subcutaneously through the back of the neck single point injection once every two weeks, three consecutive injections, six weeks after the last immunization convalescence. General clinical observation during the trial, body weight, food intake, body temperature, ophthalmology, blood cell count, coagulation, blood biochemistry, immune indicators, gross anatomy, the main organ weighing, histopathology and other tests. Results During the experiment, the animals in the main experimental group were generally in good condition. No regular changes in the toxicological significance were found in the detection of the indicators. No significant changes were observed in the weight of the animal organs in relation to the vaccine, and the gross anatomy of the organs No significant pathological changes were observed in the administration, and no obvious vaccine-related irritant response was observed in the local tissues injected. In the satellite group, the pre-immune serum antibodies were all negative. Two weeks after the last immunization, the negative control group And cell matrix antibody were all negative. The antibody positive rate was 100% in low dose group and high dose group, and the geometric mean antibody titer (GMT) was 1:73.5 and 1: 111.4, respectively. Only some rats were detectable To IFN [gamma] secreting T lymphocytes. Conclusion The long-term toxicity test of the live attenuated varicella vaccine (SV-1 cells) showed no obvious toxic reaction and the vaccine was initially proved to be safe and effective.