Zhang D L
Economic Animal Virology and Immunology Laboratory, Military Veterinary Science Institute, Beijing, PRC.
Sci China B. 1991 Aug;34(8):947-62.
In this paper, superhigh reproductive rate strains of MEV with titre more than HA8192x or TCID50 log10(9.7) have been achieved both by cultivation in cell lines with different susceptibility to MEV and by isolating and identifying in field by the author. The systematic tests proved that S18 and L12 strains of MEV are the best strains for vaccine preparation. In this study, the best means for the tissue cultivation of MEV and the most advanced technological process for the production and detection of serum-free cell-cultured MEV fluids with super-high HA titre in batches in large quantities have been established for the first time. Optimum conditions for MEV inactivation were determined, and safe and effective inactivated vaccines with mineral oil or Al(OH)3 gel adjuvant were successfully prepared with serum-free cell-cultured MEV fluids. Both vaccines with different adjuvants can be manufactured in batches in large quantities and have been widely used all over China since 1986. The change laws of the immune response kinetics of the MEV vaccines have been determined by the tests, and the indexes and laboratory animal models for monitoring humoral immune efficiency and immune protective rate of parvovirus vaccines have been established for the first time. The manufacturing and monitoring operation rules of the MEV vaccines with different adjuvants have been laid down by the author.
本文通过在对MEV敏感性不同的细胞系中培养以及作者在现场进行分离鉴定,获得了滴度超过HA8192x或TCID50 log10(9.7)的MEV超高繁殖率毒株。系统试验证明,MEV的S18和L12毒株是制备疫苗的最佳毒株。本研究首次建立了MEV组织培养的最佳方法以及大量批量生产和检测具有超高HA滴度的无血清细胞培养MEV液的最先进工艺流程。确定了MEV灭活的最佳条件,并成功地用无血清细胞培养的MEV液制备了含矿物油或氢氧化铝凝胶佐剂的安全有效的灭活疫苗。两种不同佐剂的疫苗均可大量批量生产,自1986年以来已在中国广泛应用。通过试验确定了MEV疫苗免疫反应动力学的变化规律,首次建立了监测细小病毒疫苗体液免疫效率和免疫保护率的指标及实验动物模型。作者制定了不同佐剂MEV疫苗的生产和监测操作规程。