Gheorghiu M, Lagrange P H, Fillastre C
BCG Laboratory, Pasteur Institute, Paris, France.
J Biol Stand. 1988 Jan;16(1):15-26. doi: 10.1016/0092-1157(88)90025-x.
The level of antituberculous immunity seems to be related to the number of memory T cells induced. This may vary as a function of the multiplication and persistence of BCG in host tissues. The most important requirements for a BCG vaccine are, therefore, the immunogenicity of the strain, the high proportion of live to dead bacilli, and adequate dispersion and low levels of soluble antigens. The surface-grown Pasteur BCG vaccine contains a very high proportion of bacilli killed by ball-milling and freeze-drying. It also contains clumps and soluble antigens, all factors influencing cell-mediated immune processes and viability control. Therefore, several batches of vaccine were prepared on an industrial scale using one of the most immunogenic strains (French 1173 P2) and grown as dispersed bacilli by a modified cell type culture method. This method provided fully viable, well-dispersed vaccines which have a viability and heat stability superior to that of the classical surface-grown BCG. The immunogenicity was checked by multiplication and persistence in mouse organs and the skin reactivity and tuberculin hypersensitivity in guinea-pigs showed results comparable to those obtained with classical vaccine. Small-scale tests in children showed superior immunogenicity of the dispersed as opposed to the classical vaccine and there was no suppurative adenitis.
抗结核免疫力的水平似乎与诱导产生的记忆T细胞数量有关。这可能会因卡介苗在宿主组织中的增殖和持续存在情况而有所不同。因此，卡介苗疫苗最重要的要求是菌株的免疫原性、活菌与死菌的高比例、充分分散以及低水平的可溶性抗原。表面生长的巴斯德卡介苗疫苗含有通过球磨和冷冻干燥杀死的极高比例的杆菌。它还含有团块和可溶性抗原，所有这些因素都会影响细胞介导的免疫过程和活力控制。因此，使用最具免疫原性的菌株之一（法国1173 P2）在工业规模上制备了几批疫苗，并通过改良的细胞类型培养方法培养成分散的杆菌。这种方法提供了完全有活力、分散良好的疫苗，其活力和热稳定性优于经典的表面生长卡介苗。通过在小鼠器官中的增殖和持续存在情况检查免疫原性，豚鼠的皮肤反应性和结核菌素超敏反应显示出与使用经典疫苗获得的结果相当。在儿童中进行的小规模试验表明，与经典疫苗相比，分散疫苗具有更高的免疫原性，并且没有化脓性腺炎。
