Abstract
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.
Keywords
tuberculosis vaccine - intranasally administration - ferrets - monkeys
