Abstract
Background Vaccination against tuberculosis is one of the most successful
medical measures to reduce morbidity and mortality. The BCG vaccine has been in
use for more than 100 years, but its efficacy is still controversial. New
vaccine candidates may offer better protection than available BCG vaccine. In
this work, we studied the acute and the repeated-dose toxicity study of a new
vector vaccine TB/Flu-04L against tuberculosis.
Materials and Methods The study was conducted on 60 BALB/c mice
and 150 Wistar rats. The vaccine was administered intranasally and intravenously
for the acute toxicity study. For the repeated-dose toxicity study, rats were
intranasally immunized by 6.5 log10 TCID50 or 7.5
log10 TCID50 three times with 21-day intervals.
Mortality, temperature, body weight, food and water consumption, hematological
and biochemical parameters, urine analysis, as well as cardiovascular,
respiratory, and central nervous system parameters were evaluated. A macroscopic
examination of internal organs was performed.
Results The TB/FLU-04L vaccine did not cause death among the mice
and rats in the acute toxicity study. There were no pathological abnormalities
in animal condition, behavior, food and water consumption, temperature, and body
weight during the observation period. The results suggest that intranasal
repeated-dose administration of the TB/FLU-04L vaccine does not exhibit
significant toxicity in rats.Hematological and biochemistry analysis and the histological examination
identified no toxicity-associated changes.
Conclusions The toxicity study in mice and rats showed that the intranasal
vector vaccine TB/FLU-04L had no toxic effect. The tests confirm no
adverse effects for laboratory animals in the studied parameters.