Rweyemamu M M, Litamoi J, Palya V, Sylla D
Food and Agriculture Organisation of the United Nations, Animal Health Service, Rome, Italy.
Rev Sci Tech. 1995 Sep;14(3):593-601. doi: 10.20506/rst.14.3.856.
Contagious bovine pleuropneumonia (CBPP) vaccines are routinely used only in Africa. The vaccines are usually produced from one of two strains (T1/44 and KH3J), each of which has a streptomycin-resistant variant. The necessity for a 'master seed strain' is evident. At least one manufacturer in Africa produces a broth culture vaccine, while others produce a freeze-dried product. A standardised manufacturing protocol needs to be developed, together with in-process and final product quality control procedures. Some CBPP vaccine manufacturing procedures do not allow sufficient leeway for the execution of typical quality control practices. For example, it is difficult to perform batch testing on broth culture vaccine, as the vaccine is produced in its final container. Quality control test results from the Pan African Veterinary Vaccine Centre (PANVAC) are analysed in terms of causes of batch failure and indicators for process development. Taking potency as an example, most vaccine batches tested by PANVAC pass only at the limit of the OIE minimum requirement of 10(7) colony-forming units per dose. To improve the titre of the vaccine, it will be necessary to modify the manufacturing process, either by increasing mycoplasma yield during the culture phase or by minimising losses during downstream processes, especially freeze-drying. Data on inactivated vaccines are scarce. Duration of the immunity achieved with live CBPP vaccines is relatively short, in comparison with other live vaccines. Data may be required on the molecular basis of virulence and immunogenicity, as well as on the molecular immunology of CBPP, to enable the development of improved vaccines.
牛传染性胸膜肺炎（CBPP）疫苗仅在非洲常规使用。这些疫苗通常由两种菌株（T1/44和KH3J）之一生产，每种菌株都有一个耐链霉素的变体。“主种子株”的必要性显而易见。非洲至少有一家制造商生产肉汤培养疫苗，而其他制造商则生产冻干产品。需要制定标准化的生产规程以及生产过程中和最终产品的质量控制程序。一些CBPP疫苗生产程序没有为执行典型的质量控制措施留出足够的余地。例如，对肉汤培养疫苗进行批次检测很困难，因为疫苗是在其最终容器中生产的。泛非兽医疫苗中心（PANVAC）的质量控制测试结果根据批次不合格原因和工艺开发指标进行分析。以效力为例，PANVAC检测的大多数疫苗批次仅在世界动物卫生组织每剂量10(7)个菌落形成单位的最低要求限度内通过。为提高疫苗效价，有必要修改生产工艺，要么在培养阶段提高支原体产量，要么在下游工艺（尤其是冻干）中尽量减少损失。关于灭活疫苗的数据很少。与其他活疫苗相比，活CBPP疫苗产生的免疫持续时间相对较短。可能需要关于毒力和免疫原性的分子基础以及CBPP分子免疫学的数据，以开发改进的疫苗。
