Immunomodulators of bacterial origin registered in the Russian Federation
Immunomodulators are a group of immunotropic medicines restoring immune system dysfunctions. Modern classification of immunomodulators used for human infectious disease pathology correction includes three groups of medicines: exogenous, endogenous and chemical pure. The present article summarizes the materials on the use and quality control of bacterial immunomodulators registered in the Russian Federation. It provides the information on the composition, therapeutic indications, dosage forms for Vaccinum BCG, Imuron-Vac, Vaccine Uro-BCGmedac, Pyrogenalum, Posterisan®, Broncho-munal®, IRS®-19, Ribomunyl®, Imudon®, Ismigen, Uro-Vaxom®, SolcoUrovac® etc. Bacterial immunomodulators may have significant differences in composition, therapeutic indications, dosage forms, but all products of this group have a common mechanism of action: specific (vaccination effect) and nonspecific (immunostimulatory effect). The article also provides the information on adverse reactions to administering the preparations of the mentioned group. It describes the requirements for preclinical and clinical trials of newly developed immunomodulators. In preclinical studies the immunomodulatory effects of a new medicine on the components of the immune system and their safety must be confirmed in animal models. Subsequent clinical trials must ensure the safety of a new immunomodulator for human as well as to confirm immunological and clinical efficacy. Upon a positive decision on the possibility of medical use of a new immunomodulator, the main task is to ensure its proper quality in a commercial release. The article describes the requirements for the quality of immunomodulators, depending on their intended use, as well on the variety of quality assessment methods.