重组乙型肝炎疫苗(CHO细胞)及其应用

Recombinant Hepatitis B (CHO-derived) Surface Antigen Vaccine and Its Immune Effects

通过重组乙型肝炎(乙肝)疫苗[中国仓鼠卵巢细胞(CHO细胞)]种子细胞、生产工艺验证和临床观察资料的比较,阐明重组乙肝疫苗(CHO细胞)的安全性和有效性,并介绍了第三代重组乙肝疫苗(CHO细胞)(Pre-S/S)。对细胞致瘤性、生产工艺病毒灭活能力、脱氧核糖核酸(DNA)残留量、CHO细胞残留蛋白的考察,证实重组乙肝疫苗(CHO细胞)质量完全达到世界卫生组织(WHO)和欧洲药典标准。该疫苗用于新生儿、儿童、成人预防接种和母婴阻断安全、有效。我国研制的重组乙肝疫苗(CHO细胞)安全、有效,为进一步研制新的预防和治疗用乙肝疫苗奠定了基础。

To clarify the safety and immune effects of recombinant hepatitis B(CHO-derived)surface antigen (HBsAg) vaccine by the data of validation of CHO cell and process and the date of clinical application. To introduce the 3rd generation vaccine (Pre-S/S). Hepatitis B vaccine (CHO-derived) meets the criteria of WHO and European Pharmacopoeia concerning about CHO tumorigenesis,viral clearance in the process, residual DNA and host protein. Clinical data showed that this vaccine is safe and effective for newnates,children, and adults preventing from virus infection and for blocking the maternal-infant transmission. Hepatitis B vaccine (CHO-derived) developed by Chinese scientists is safe and effective,it is the basis for research and development more effective vaccine in the futime.