A New Intranasal Influenza Vector-Based Vaccine TB/FLU-04L Against Tuberculosis: Preclinical Safety Studies
Buzitskaya Z. Stosman K. Khairullin B. Kassenov M. Nurpeisova A. Abylai Sansyzbay A. Shurygina A.-P. Aleksandrov A. Sivak K. Stukova M.
2022Georg Thieme Verlag
Drug Research
2022#72Issue 5255 - 258 pp.
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 NS 106/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 TCID 50/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.
ferrets , intranasally administration , monkeys , tuberculosis vaccine
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Smorodintsev Research Institute of Influenza, Professora Popova str., 15/17, St. Petersburg, 197376, Russian Federation
The Research Institute for Biological Safety Problems, Gvardeisky, Kazakhstan
Smorodintsev Research Institute of Influenza
The Research Institute for Biological Safety Problems
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