A recombinant vector vaccine TB/FLU-04L for the prevention of tuberculosis was developed in RIBSP CS MES RK and SRII. The vaccine is based on the attenuated influenza strain Flu NS106/ESAT-6_Ag85A expressing mycobacterial antigens Esat-6 and Ag85A. This research aimed to conduct pre-clinical safety studies of the vaccine as one of the basic and mandatory stages in the development and introduction of immunobiological preparations. The studies were performed at the research centers of the Republic of Kazakhstan and the Russian Federation.The experiment was conducted on ferrets, monkeys, and rabbits. The TB/FLU-04L vaccine was administered intranasally (7.5 lg TCID50/animal). The clinical signs, body weight, temperature, hematological parameters, and local irritant effects were monitored throughout the study. The results of the study demonstrated the safety of the TB/FLU-04L intranasal vector vaccine against tuberculosis since its administration in laboratory animals led to no adverse effects in any of the monitored parameters. No influenza A virus particles were isolated from samples of nasal washes.

Background: While the most common pharmacological treatments for autoimmune renal pathologies are well studied, herbal remedies are often overlooked. In this study, the effect of the herbal treatment Canephron® N (CAN) in a rat model of active Heymann's autoimmune glomerulonephritis (AIG) was investigated. Methods: Forty BDIX male conventional rats and six female rats were divided into the following groups: healthy animals, AIG, AIG treated with CAN, AIG treated with prednisolone, AIG treated with prednisolone and CAN. Results: Prednisolone or CAN monotherapy comprises various positive pharmacological effects. Rats receiving prednisolone showed moderate increase in CD4+ lymphocyte count, increase in CD8+ cytotoxic lymphocyte count but incomplete normalization of CD4+/CD8+ lymphocyte ratio. It reduced the total count of lymphocytes. Concentration of immune complexes and cryoglobulin level decreased considerably. Prednisolone monotherapy ensured moderate reduction in nephrotic syndrome parameters. CAN monotherapy did not affect immunological parameters and CD4+/CD8+ subpopulation ratio but reduced the level of immune complexes significantly compared to AIG. The main nephroprotective effects of the drug were normalization of diuresis and glomerular filtration rate. Significant reduction of leukocyturia was observed compared to AIG group. The most positive effects were observed in the combined Prednisolone + CAN group. Along with positive immunological shifts in cell-bound and humoral links of immunity (prednisolone effects), renal function improved significantly: proteinuria decreased, blood creatinine and urea decreased, AOPP and PCO levels also decreased (combined effects of CAN). Qualitative differences suggest synergistic effects of complex therapy with glucocorticoid immunosuppressor and the herbal medical drug. Conclusions: The AIG model used in this study corresponds to human membranous glomerulonephritis in terms of clinical morphology. Prednisolone monotherapy demonstrated adequate efficacy regarding immune and metabolic components of renal disease. The herbal monotherapy was shown to partially normalize urodynamics. Combining CAN with the immunosuppressant prednisolone promotes more positive pharmacodynamic effects on the immune and renal systems of rats. The combined treatment may be useful in clinical nephrology practice including patients with kidney autoimmune diseases and should be investigated further.

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