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目的 利用恒河猴评价实验性SARS冠状病毒灭活疫苗免疫原性与安全性。方法 动物免疫分3组,分别为肌肉注射0.5μg、5μg、50μg疫苗组及磷酸盐缓冲液(PBS)对照组,同时设超大剂量(5000μg)观察疫苗安全性,并于初次免疫后7 d再次免疫,监测免疫前后动物体液免疫、黏膜免疫及血清细胞因子变化,观察临床症状及生化指标。结果 0.5μg和5μg剂量组可诱导部分免疫应答,50μg剂量组则能诱导针对SARS CoV的特异性免疫应答,且各免疫组动物均未出现不良反应。结论SARS CoV灭活疫苗在恒河猴体内能有效诱导针对SARS CoV感染的体液和黏膜免疫应答并且安全性较好。
Objective To evaluate the immunogenicity and safety of the experimental SARS coronavirus inactivated vaccine using rhesus monkeys. Methods Animal immunization was divided into three groups: intramuscular injection of 0.5μg, 5μg, 50μg vaccine group and PBS control group respectively. At the same time, a large dose (5000μg) was used to observe the safety of the vaccine. After the first immunization, Immunization, monitoring before and after immunization of animal humoral immunity, mucosal immunity and serum cytokines, observe the clinical symptoms and biochemical indicators. Results The partial immune responses were induced in 0.5μg and 5μg dose groups, and the specific immune response against CoV in SARS was induced in 50μg dose group. No adverse reactions were observed in the immunized groups. Conclusions The SARS CoV inactivated vaccine can effectively induce the humoral and mucosal immune responses against SARS CoV infection in rhesus monkeys and is safe.