摘要
目的观察单层及悬浮吸附工艺不同收毒时间生产的H2株甲型肝炎减毒活疫苗(以下简称甲肝活疫苗)接种恒河猴的安全性及免疫效果。方法筛选甲肝抗体阴性,丙氨酸转胺酶(ALT)正常的恒河猴15只,随机分为3组,每组5只,下肢静脉注射疫苗1 ml/只。接种3 d内,每天观察有无局部和全身反应,0,2,3,4,6,8周采血测ALT及甲肝抗体,0,4,8周肝穿做组织病理检查,观察到期尸检。结果接种疫苗3 d内,所有恒河猴均无局部和全身反应。观察全程ALT正常,肝脏无特殊组织病理改变。免后4周甲肝抗体全部阳转,单层工艺26 d疫苗、悬浮工艺23和26 d疫苗几何平均滴度(GMT)4周分别为9.2,14.9和27.9;8周分别为32,64和64;悬浮工艺23 d和26 d疫苗猴体免疫效果相似,且两者均明显优于单层工艺疫苗。结论悬浮吸附工艺23 d收毒疫苗接种恒河猴具有较好的安全性和可靠的免疫效果,采用悬浮吸附工艺生产H2株甲肝活疫苗23 d收获病毒较经济和稳妥。
Objective Objective To observe the safety and immune effect of live attenuated hepatitis A vaccine （H2 strain） produced by mono-layer absorption and suspension absorption with different virus harvest period in rhesus monkeys. Methods Fifteen rhesus monkeys with negative anti-HAV and normal level of alanine transaminase（ALT） were selected and divided randomly into 3 groups. A group of 5 animals for 1 specimen and 1 ml of vaccine was injected by IV into each rhesus monkey. The local and systemic reactions were observed within 3 days after injection. Both anti-HAV and ALT were detected at wk 0, 2, 3, 4, 6, 8 and liver puncture was performed at wk 0, 4, 8 for histopathological examination. Autopsy was down at the end of observation. Results No local and systemic reactions were observed in any rhesus monkeys within 3 days after vaccination, The ALT levels were normal and no specific liver histopathological change were examined during whole period. The seroconversion rate of anti-HAV was 100% at 4 wk after inoculation. The GMTs were 9.2, 14.9,27.9 for mono-layer absorption vaccine （26 d harvest）, suspension absorption vaccine （23 d harvest） and suspension absorption vaccine （26 d harvest） at 4 wk and 32, 64, 64 at 8 wk. The immune effects induced by 2 suspension absorption vaccine were similar, but better than that mono-layer absorption. Conclusion Suspension absorption with 23 d harvest technique vaccine possesses good safety and immune effect in rhesus monkey inoculation. The application of suspension absorption （23 d harvest） technique for production of hepatitis A vaccine （H2 strain） is economic and practicable.
出处
《中国公共卫生》
CAS
CSCD
北大核心
2005年第10期1186-1187,共2页
Chinese Journal of Public Health
关键词
甲肝活疫苗
悬浮吸附
恒河猴
免疫效果
live attenuated hepatitis A vaccine
suspension absorption
rhesus monkey
safety
immune effect
