摘要
目的评价非动物源性保护剂的冻干乙型脑炎减毒活疫苗在动物体内的安全性和保护效力,以及在不同温度存放时间疫苗滴度变化。方法皮下或腹腔途径免疫小鼠后,检测体内中和抗体效价,P3株脑内或腹腔内攻击评价疫苗保护效力。于4℃和37℃在不同存放时间,观察疫苗稳定性。结果皮下或腹腔途径免疫后,小鼠体内中和抗体效价不高于1:10;P3株脑内攻击14 d后,小鼠存活率为80%以上;P3株腹腔内攻击14 d后,小鼠存活率为100%;脑内致病力,乳鼠传代返祖及异常毒性试验等疫苗安全性各项指标合格;疫苗4℃存放半年后滴度下降0.19 Log10PFU/mL;37℃下存放7 d,滴度下降0.71 Log10PFU/mL。结论非动物源性保护剂的冻干乙型脑炎减毒活疫苗在小鼠体内具有良好的安全性及免疫保护力,于4℃长期保存,疫苗滴度稳定。
Objective To assess safety, protection in mice by using a non-animal origin derived stabilizer in lyophilized at-tenuated Japanese encephalitis vaccine, and observe changes of efficacy in the vaccine stored in different temperature and time. Methods Immunization mice by using the vaccine i. s or i. p, then challenge mice by way of intrabrain or peritoneal with a P3 strain, neutralization-antibody and immune protection were detected. Stability for efficacy in the vaccine was e-valuated in different stored time in 4 ℃ or 37 ℃. Results Titer of neutralizing-antibody was no more than 1 ： 10 with i. s or i.p. The protection rate against intrabrain challenge of P3 strain was more than 80% over 14 days, and it was 100% over 14 days by the peritoneal challenge. The safety of vaccine in mice was proved by a series of experiments including in-trabrain infectivity and reverse mutation test in suckling mice. The titer of efficacy in vaccine was reduced by 0. 19 Log10PFU/mL after 6 months stored at 4 ℃, and reduced by 0.71 Logj0PFU/mL after 7 days stored at 37 ℃. Conclusion Lynphilized attenuated Japanese encephalitis vaccine with a stabilizer derived from non-animal origin was safe and effec-tive in mice test. The efficacy of vaccine could be stable at 4 ℃ for a long time.
出处
《微生物学免疫学进展》
2013年第2期11-14,共4页
Progress In Microbiology and Immunology
关键词
乙型脑炎减毒活疫苗
安全性
保护力
稳定性
保护剂
冻干
Attenuated Japanese Encephalitis Vaccine, Safety, Protection, Stability, Stabilizer, Lyophilization
