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Background Vaccination against tuberculosis is one of the most successfulmedical measures to reduce morbidity and mortality. The BCG vaccine has been inuse for more than 100 years, but its efficacy is still controversial. Newvaccine candidates may offer better protection than available BCG vaccine. Inthis work, we studied the acute and the repeated-dose toxicity study of a newvector vaccine TB/Flu-04L against tuberculosis.  Materials and Methods The study was conducted on 60 BALB/c miceand 150 Wistar rats. The vaccine was administered intranasally and intravenouslyfor the acute toxicity study. For the repeated-dose toxicity study, rats wereintranasally immunized by 6.5 log10 TCID50 or 7.5log10 TCID50 three times with 21-day intervals.Mortality, temperature, body weight, food and water consumption, hematologicaland biochemical parameters, urine analysis, as well as cardiovascular,respiratory, and central nervous system parameters were evaluated. A macroscopicexamination of internal organs was performed.  Results The TB/FLU-04L vaccine did not cause death among the miceand rats in the acute toxicity study. There were no pathological abnormalitiesin animal condition, behavior, food and water consumption, temperature, and bodyweight during the observation period. The results suggest that intranasalrepeated-dose administration of the TB/FLU-04L vaccine does not exhibitsignificant toxicity in rats.  Hematological and biochemistry analysis and the histological examinationidentified no toxicity-associated changes.  Conclusions The toxicity study in mice and rats showed that the intranasalvector vaccine TB/FLU-04L had no toxic effect. The tests confirm noadverse effects for laboratory animals in the studied parameters.

Preclinical Safety Evaluation: Acute and Repeated-Dose Toxicity of a New Intranasal Recombinant Vector Vaccine TB/FLU-04L Against Tuberculosis