Proposals for quality control methods of bacterial vaccines for immunostimulation. I. General considerations.

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.