CAJ | 학술논문

目的以Vero细胞为基质,研制安全有效的乙型脑炎灭活疫苗.方法将经Vero细胞适应的乙型脑炎病毒P3株接种Vero细胞,培养后收获病毒液.采用β-丙内酯灭活,通过超滤浓缩、硫酸鱼精蛋白沉淀、蔗糖密度梯度离心等方法纯化病毒,最终配制成预防乙型脑炎病毒感染的疫苗.通过临床试验考察疫苗的安全性及免疫原性.结果该疫苗的主要考核指标,如病毒滴度、总蛋白含量、Vero细胞DNA残留量、效价等均符合国家标准.临床观察结果显示,接种本疫苗后局部及全身反应轻微;各年龄组乙型脑炎病毒中和抗体阳转率均>90%.结论采用本法制备的疫苗安全有效.
목적 이Vero세포위기질,연제안전유효적을형뇌염멸활역묘.방법 장경Vero세포괄응적을형뇌염병독P3주접충Vero세포,배양후수획병독액.채용β-병내지멸활,통과초려농축、류산어정단백침정、자당밀도제도리심등방법순화병독,최종배제성예방을형뇌염병독감염적역묘.통과림상시험고찰역묘적안전성급면역원성.결과 해역묘적주요고핵지표,여병독적도、총단백함량、Vero세포DNA잔류량、효개등균부합국가표준.림상관찰결과현시,접충본역묘후국부급전신반응경미;각년령조을형뇌염병독중화항체양전솔균>90%.결론 채용본법제비적역묘안전유효.
Objective To develop a safe and efficacious inactivated Japanese encephalitis(JE)vaccine base on Vero cells.Methods A JE virus P3 strain adapted on Vero cells was inoculated and cultivated on Vero cells.The virus harvest was inactivated with β-propiolactone.Then the inactivated virus was concen trated by ultra-filtration,precipitated with protamine sulfate and purified by sucrose density gradient centrifugation.Finally the purified virus was formulated to be a vaccine.The vaccine was studied for safety and immuno genicity through clinical trials.Results The virus titer,total protein contents,residual DNA contents and potency of the vaccine met the requirements of the Chinese Pharmacopoeia(edition 2005).The clinical trials showed that local and systemic reactions were minimal and antibody positive conversion rates in all age groups tested reached above 90% after vaccination.Conclusion The inactivated JE vaccine prepared by this process is safe and effective.