[Assessment of safety of lyophilized substance of antibacterial peptide complex].

AIM: To assessment acute and chronic toxicity and local irritative effect of antibacterial peptide complex (ABC) substance extracted from interferon preparations. MATERIALS AND METHODS: Preclinical assessment of ABC substance was performed according to "Requirements for preclinical study of overall toxicity of new pharmacological substances". RESULTS: Series of experiments showed that single or prolonged (during 30 days) administration of ABC substance solution to mice intragastrically or rectally in maximal doses did not lead to death of experimental animals or pathological changes in their organs during pathomorphological and histological studies. Assessment of immune system state showed that administration of solution of studied substance during 1 month in dose 25 times higher than therapeutic leaded to stimulation of phagocytic activity of peripheral blood neutrophils. CONCLUSION: Assessment of acute and chronic toxicity showed that substance of ABC synthesized by virus-induced donor leukocytes during interferon synthesis is well tolerated by experimental animals, does not render toxic effects on their organisms, and possesses immunomodulating activity.

[Evaluation of reactogenicity and immunogenicity of Bubo-M, the Russian combined vaccine for immunization of adults against diphtheria, tetanus and viral hepatitis B]. / Otsenka reaktogennosti i immunogennosti otechestvennoi kombinirovannoi vaktsiny Bubo-M pri immunizatsii vzroslykh protiv difterii, stolbniaka i virusnogo gepatita B.

Bubo-M, the first Russian associated vaccine, was found to have low reactogenicity and high immunogenic potency. The frequency of postvaccinal reactions in the group of persons immunized with Bubo-M (20%) appeared to be considerably lower than among persons who received the combined injection of adsorbed DT toxoid with reduced antigen content and vaccine against hepatitis B (47.7%). Following the course of vaccination the level of anti-HBs considerably exceeded the protective level. Immune response to the diphtheria and tetanus components of Bubo-M exceeded that observed after immunization with absorbed DT toxoid with reduced antigen content (p < 0.05).

[Reactions to and immunogenic properties of the combined vaccine Bubo-M for immunization of children against diphtheria, tetanus and viral hepatitis B]. / Reaktogennost' i immunogennost' kombinirovannoi vaktsiny Bubo-M pri immunizatsii detei protiv difterii, stolbniaka i virusnogo gepatita B.

Bubo-M, the first Russian combined vaccine, was found to have low reactogenicity. The difference between the number of postvaccinal reactions in the group of children immunized with Bubo-M (25.9%) and those in the group of children who had been simultaneously injected into different sites of the body with ADS-M toxoid (adsorbed DT toxoid with reduced antigen content) and hepatitis B vaccine (26.7%) was not statistically significant. Following immunization a considerable increase in the level of diphtheria and tetanus antibodies (p < 0.005) was observed in all children (100%), the level of HBs antibodies in the group of children immunized with Bubo-M (the geometric mean titer: 13,721 IU/l) essentially exceeding that observed in the control group injected with ADS-M toxoid and hepatitis B vaccine (the geometric mean of the titer: 2,441 IU/l). Bubo-M was duly registered and allowed for industrial production and medical use.

[Immunotropic effects of molokin]. / Immunotropnye éffekty molokina.

The immunopharmacological properties of Molokin, a polypeptide preparation obtained from the milt of fish of the salmon family, were studied. The Molokin was shown to activate the phagocytosis of macrophages, to increase the number of antibody-forming cells, to elevate antibody titers in mice with high reactivity (CBA) and low reactivity (C57BL).