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目的研制甲肝灭活疫苗。方法甲型肝炎病毒TZ84株、吕8株接种人胚肺二倍体细胞2BS、KMB17株,经培养繁殖、收获、提纯、甲醛溶液灭活和氢氧化铝吸附制成灭活疫苗。结果纯化的甲肝病毒经HPLC、SDS-PAGE等方法检测表明具有良好的纯度。灭活工艺经验证盲传三代证明灭活可靠。甲肝灭活疫苗在豚鼠、小白鼠、ICR小鼠、恒河猴和普通狨猴上具有良好的安全性和免疫原性;经539例临床研究表明,该疫苗儿童组和成人组副反应均轻微,全程免疫后接种者100％抗体阳转,儿童组0,6月注射500u全程免疫后抗体水平达4535mIU/ml,成人组注射500u 0,6月全程免疫后抗体水平为1657mIU/ml,均可获得较长期的保护效果;该疫苗2～8℃保存21个月、37℃保存32天,质量稳定。结论甲肝灭活疫苗安全、有效、稳定。
Objective To develop hepatitis A inactivated vaccine. Methods Hepatitis A virus TZ84 strain and Lu 8 strain were inoculated with 2BS and KMB17 strains of human embryonic lung diploid cells. The inactivated vaccine was produced by inoculation, harvesting, purification, formaldehyde solution inactivation and aluminum hydroxide adsorption. Results The purified hepatitis A virus was detected by HPLC, SDS-PAGE and other methods showed good purity. Demonstration of inactivation process proved blind pass three generations of proven inactivated. The hepatitis A inactivated vaccine has good safety and immunogenicity in guinea pigs, mice, ICR mice, rhesus macaques and common marmosets. The 539 clinical studies showed that the vaccine had minor side effects in children and adults , The whole immunization vaccination 100% positive antibody to children, children in June and June after injection of 500u whole immune antibody level 4535mIU / ml, adult group injected 500u 0, 6 months after the whole immune antibody level 1657mIU / ml, can be The vaccine was preserved for 21 months at 2-8 ℃ and stored for 32 days at 37 ℃ with stable quality. Conclusion Hepatitis A inactivated vaccine is safe, effective and stable.