BCG vaccine is an immunostimulating agent. It has anti-tumor activity, but the exact mechanism of action is not known. Study data suggest that an active non-specific immune response takes place. BCG invokes a local inflammatory response involving a variety of immune cells, such as macrophages, natural killer cells and T cells.
For the treatment and recurrence prophylaxis of bladder cancer, the attachment of BCG to the bladder wall after voiding has been shown to be important. This allows a targeted pharmacological effect at the site of application.
As a result of the wide clinical application of BCG vaccination in the preceding decades the risks of BCG in human subjects are well-characterised. Intra-vesical administration to dogs has been found to be safe and without significant toxicity. No evidence of birth defects, genetic damage or carcinogenecity in humans are available from the extensive adverse reaction literature of BCG used as a vaccine.
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