Smorodintsev Research Institute of Influenza, St. Petersburg, Russian Federation (SRII).
The Research Institute for Biological Safety Problems, Gvardeisky, Republic of Kazakhstan (RIBSP CS MES RK).
Drug Res (Stuttg). 2022 Jun;72(5):255-258. doi: 10.1055/a-1785-3936. Epub 2022 Mar 22.
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/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/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.
一种用于预防结核病的重组载体疫苗 TB/FLU-04L 在 RIBSP CS MES RK 和 SRII 中被开发出来。该疫苗基于减毒流感株 Flu NS/ESAT-6_Ag85A，表达分枝杆菌抗原 Esat-6 和 Ag85A。本研究旨在对疫苗进行临床前安全性研究，这是免疫生物制剂开发和引入的基本和强制性阶段之一。这些研究是在哈萨克斯坦共和国和俄罗斯联邦的研究中心进行的。该实验在雪貂、猴子和兔子身上进行。TB/FLU-04L 疫苗经鼻内（7.5 lg TCID/动物）给药。在整个研究过程中，监测临床症状、体重、体温、血液学参数和局部刺激性效应。研究结果表明，TB/FLU-04L 鼻内载体疫苗对结核病是安全的，因为在实验动物中给药后，在任何监测参数中都没有不良影响。从鼻腔冲洗样本中未分离到甲型流感病毒颗粒。
