Healive^(TM)甲型肝炎灭活疫苗的生产与应用

The Healive^(TM) Inactivated Domestic Hepatitis A Vaccine:Production and Application

20 0 0年 ,中国第 1支拥有自主知识产权的HealiveTM 甲型肝炎 (甲肝 )灭活疫苗历经 4年研制取得成功。HealiveTM甲肝灭活疫苗灭活纯度高 ,工艺稳定、重复性好。Ⅰ、Ⅱ、Ⅲ期临床研究表明 ,该疫苗安全性好 ,全程免疫后抗体阳转率为 10 0 % ,抗体几何平均滴度 (GMT)成人为 16 5 7mIU/ml,儿童为 5 96 3mIU/ml。其它临床研究 ,包括在乙型肝炎 (乙肝 )病毒表面抗原阳性儿童和 1～ 4岁儿童中应用HealiveTM 甲肝灭活疫苗免疫 ,以及用HealiveTM甲肝灭活疫苗为接种甲肝减毒活疫苗者做加强免疫 ,均取得良好效果。上市后小范围精细安全性观察及大规模安全性观察 ,再次证明了HealiveTM甲肝灭活疫苗的安全性 ;HealiveTM 甲肝灭活疫苗的保护效果在平山县小范围甲肝流行中得到初步证明。因此 ,推广使用HealiveTM甲肝灭苗疫苗 ,将会产生良好的社会效益和经济效益。

In year of 2000,the first inactivated hepatitis A vaccine-Healive TM with our own intellecture property rights(IPRs)was developed after four-year study on it.Healive TM is fully purified,and its production process is highly stabilized.The safety of Healive TM has been proved in phase Ⅰ,Ⅱ and Ⅲ clinical trials.After the 2-dose regimen,the positive seroconversion rates were 100%,GMTs were 1 657 mIU/ml in adults and 5 963 mIU/ml in children,respectively. Results of the other clinical studies illustrated that Healive TM has high adaptability,including in the groups of HBsAg carriers,and 1-4 year old young children and in those who had received the live attenuated hepatitis A vaccine.After Healive TM was launched into the market,both the subtle observation in small range and the extensive observation in large scale,it further demonstrated the safety of Healive TM . The protective efficacy had been initially proved in limited area during HAV prevalence in Pingshan County.Therefore,popularizing the use of Healive TM will bring social and economic benefits.