Chouchkova M, Engibarov A
Dev Biol Stand. 1986;58 ( Pt A):105-18.
Batches of freeze-dried BCG vaccine were produced by using two different substrains--Moscow (SL 374a) and Paris (SL 1173 P2). The biological activity of the vaccines was studied by the following tests: In the laboratory--viability, heat stability, homogeneity, skin reactivity, allergenic potency and immunogenicity in guinea pigs. In the field--local lesions and postvaccination tuberculin sensitivity. All the batches were produced by using the same technique and production methods. The Paris substrain vaccines showed less viability, but higher heat stability and skin reactivity. It is to be noted that when the VKL medium was used (instead of Sauton) the Paris substrain vaccines showed much lower immunogenicity in guinea pigs and, at the same time, much higher skin reactivity. In the field studies the Moscow substrain vaccines showed higher local lesions and tuberculin sensitivity. In other experiments vaccines produced from the same substrain (Moscow) but in different production centers were compared. It was found that the vaccines differed (according to the production methods used) in terms of some laboratory tests (viability, heat stability, homogeneity) but these differences were not associated with significant differences when studied in the field.
冻干卡介苗批次采用两种不同的亚菌株——莫斯科株（SL 374a）和巴黎株（SL 1173 P2）生产。通过以下试验研究疫苗的生物学活性：在实验室——活力、热稳定性、均匀性、皮肤反应性、变应原效力和在豚鼠中的免疫原性。在现场——局部损伤和接种后结核菌素敏感性。所有批次均采用相同的技术和生产方法生产。巴黎亚菌株疫苗的活力较低，但热稳定性和皮肤反应性较高。需要注意的是，当使用VKL培养基（而非苏通培养基）时，巴黎亚菌株疫苗在豚鼠中的免疫原性低得多，同时皮肤反应性高得多。在现场研究中，莫斯科亚菌株疫苗表现出更高的局部损伤和结核菌素敏感性。在其他实验中，比较了同一亚菌株（莫斯科株）但在不同生产中心生产的疫苗。发现这些疫苗在一些实验室试验（活力、热稳定性、均匀性）方面（根据所使用的生产方法）存在差异，但在现场研究时，这些差异与显著差异无关。
