Sirks J L, Ruitenberg E J
Dev Biol Stand. 1977;38:87-9.
Control methods for this type of vaccines include tests on identity, absence of contaminating microorganisms and safety which are required for any vaccine. In addition, for the control of vaccines for immunostimulation in cancer therapy some special methods for safety and potency testing are required. Some assays are proposed, such as stimulation of lymphocytes in vivo and in vitro, stimulation of macrophages (listeria clearance) in mice and the prophylactic and therapeutic tumor model in mice. Details of these tests are given in the companion papers II and III. The influence of the method of preparation of BCG vaccines on its mode of action in some of these models will be emphasized.
这类疫苗的控制方法包括对任何疫苗都需要进行的鉴别测试、无污染微生物检测和安全性检测。此外，对于癌症治疗中免疫刺激疫苗的控制，还需要一些特殊的安全性和效力检测方法。有人提出了一些检测方法，如体内和体外淋巴细胞刺激、小鼠巨噬细胞刺激（李斯特菌清除）以及小鼠预防性和治疗性肿瘤模型。这些检测的详细信息在配套论文II和III中给出。将强调卡介苗制备方法对其在其中一些模型中作用方式的影响。
