【作者】 庄昉成； 柴少爱； 陈念良； 万宗举； 毛子安； 黄世贵； 姜器； 忻亚娟； 钱汶； 毛江森；

【Author】 Zhuang Fang-cheng, Chai Shao-ai, Chen Nian-liang, et al (Institute of Viral Diseases,Zhejiang A cademy of Medical Science, Hangzhou,310013)

【机构】 浙江省医学科学院病毒病研究所； 中国药品生物制品检定所； 广西蒙山县卫生防疫站； 浙江省台州市椒江区疾病预防控制中心；

【摘要】 为观察H2株冻干甲型肝炎(甲肝)减毒活疫苗接种人体后的安全性和免疫原性,选择广西壮族自治区蒙山县一小学学生(年龄7—12岁)164人和浙江省台州市椒江区一幼儿园儿童(年龄3—6岁)114人为接种对象,免疫前筛选抗甲肝病毒IgG抗体(抗-HAV-IgG)阴性,血清丙氨酸氨基转移酶(SGPT)正常,无肝炎病史、症状和体征者,分别接种2个批号的H2株冻干甲肝活疫苗。观察接种疫苗后30min,8、24、48、72h的局部及全身反应,以后隔天记录体温及其它有关临床反应。接种疫苗后1、2个月采静脉血测定SGPT及抗-HAV—IgG,同时长期随访检测免疫后13、24个月血清抗-HAV—IgG水平。检测用酶免疫测定(EIA)竞争抑制法,用世界卫生组织 (WHO)提供的标准品(含100mlU／ml)进行标定。结果显示:在整个观察期间,所有观察者未见中、强反应及其它临床反应发生,SGPT检测结果元异常升高。H2株冻干甲肝活疫苗具有良好的安全性。接种疫苗后2个月抗体阳性率为99．1％-100．0％,13～24个月阳性率仍高达97．8％-98．9％;免疫后2个月抗体几何平均滴度(GMT)达 1607mlU／ml,在免疫后24个月抗体GMT仍维持在448．3mlU／ml。表明H2株冻干甲肝活疫苗安全性良好,接种后有较高的抗体阳转率和GMT。更多还原

【Abstract】 To assess the safety and immunogenicity of freeze-dried live attenuated hepatitis A (HA)vaccine (H2 strain) inoculated to humans, we chose 164 primary school students of 7-12 years old from Mengshan County of Guangxi Autonomous Region and 114 kindergarten children of 3~6 years old from Jiaojiang District of Taizhou city of Zhejiang Province. They were all anti-HAV-IgG negative, SGPT normal, no epatitis history and no hepato-symptoms. These two groups of subjects were inoculated separately with two different batches of freeze-dried live attenuated HA vaccine H2 strain,and then observed for systemic and local reactions 30min, 8, 24, 48, 72h after vaccination, their body temperatures and clinical reactions were recorded every other day. Their blood samples were collected 1 and 2 months after vaccination for anti-HAV-IgG and SGPT testing. When followed up as long as 13 and 24 months, anti-HAV-IgG was tested again by EIA competition inhibition assay marked by WHO standard sample (100mIU/ml). The results showed that during the whole period of observation, no medium and severe adverse effects or any clinical reactions were seen, no SGPT abnormality, suggesting that H2 vaccine is safe. The positive sero-conversion rates of this vaccine vaccinated after 2 months,13~24 months were 99.1%~100 % and 97.8 %~98.9 % respectively. The GMT after 2 months reached 1607mIU/ml and maintained at 448.3mIU/ml after 24 months, which was 4 times higher than that of the same domestic product 2 months after inoculation. The imraunogenicity of freeze-dried live attenuated HA vaccine H2 strain is satisfactory.更多还原