Barin F, André M, Goudeau A, Coursaget P, Maupas P
Ann Microbiol (Paris). 1978 Jul;129B(1):87-100.
In October 1975, a specific immunization by means of a formalin inactivated hepatitis B vaccine has been introduced to protect patients and staff members of three haemodialysis units of the Loire Valley (Tours, Blois, Orléans). After two years follow-up the innocuity and efficacy of this preparation have been shown to be very satisfactory in the conditions under which it was used. A method of vaccine preparation has been instituted in the development of industrial batches of vaccine to be used for broad clinical trials in France. The HBsAg purification was carried out by four different steps including, successively, selective adsorption-desorption on colloidal silicate (Aerosil), precipitations by polyethylene glycol, gel filtration and finally zonal ultracentrifugation. Step-by-step results of the purification are presented. Up to 65 % of the starting antigen was recovered at the end of the purification process. One dose of vaccine (1 ml) has a titre in HBsAg of 1/4 in countercurrent electrophoresis and a protein amount of 2-10 micron/ml. It contains traces of homologous serum proteins only detectable after high concentration. Purity, antigenic quality and safety of the vaccine are analysed in regards to its use for immunization against hepatitis B in man.
1975年10月，一种通过福尔马林灭活的乙肝疫苗被引入，用于保护卢瓦尔河谷地区（图尔、布卢瓦、奥尔良）三个血液透析单位的患者和工作人员。经过两年的随访，该制剂在使用条件下的安全性和有效性已被证明非常令人满意。在开发用于法国广泛临床试验的工业批次疫苗时，制定了一种疫苗制备方法。乙肝表面抗原（HBsAg）的纯化通过四个不同步骤进行，依次为在胶体硅酸盐（气相二氧化硅）上的选择性吸附-解吸、聚乙二醇沉淀、凝胶过滤，最后是区带超速离心。给出了纯化的分步结果。在纯化过程结束时，回收了高达65%的起始抗原。一剂疫苗（1毫升）在对流电泳中的HBsAg滴度为1/4，蛋白质含量为2 - 10微克/毫升。它仅含有在高浓度后才可检测到的微量同源血清蛋白。针对该疫苗用于人体乙肝免疫的情况，对其纯度、抗原质量和安全性进行了分析。
