MOSCOW, October 15. /TASS/. Patients at the Smorodintsev Research Institute of Influenza received the first doses of the Betuvax vaccine on Friday as part of the jab’s clinical trials, the press service of the Human Stem Cell Institute (HSCI) company which developed the preparation together with the Betuvax company told TASS on Friday.
"On Friday, October 15, in St. Petersburg at the Smorodintsev Research Institute of Influenza, the first patients received the Betuvax-CoV-2 vaccine within the framework of its Phase 1-2 clinical trials. According to a protocol approved by the Health Ministry, the trials <…> will be conducted on 170 patients," the company’s press service told TASS.
The trial participants will receive two components of the jab with a 28-day interval between the two. According to Director General of the KEG Bio contract research company Nikolai Kryuchkov, the first 20 selected volunteers will receive the actual preparation, the use of a placebo is planned for subsequent stages. Earlier, the developers of the vaccine reported that there should be minimal side effects thanks to the special features of the composition of this subunit recombinant vaccine.
"It contains only the surface antigens of the coronavirus which allows us to decrease the protein content, and, as a result, decrease the preparation’s allergenicity. The vaccine does not contain viruses or viral vectors, any genetic material in the DNA or RNA form, excess antigenic load, additional preservatives, stabilizers or inorganic adjuvants which minimizes the risks of side effects," the company said to TASS.
Following the results of clinical trials on animals, the Betuvax-CoV-2 vaccine demonstrated a good safety and efficacy profile with the formation of high neutralizing antibody titers against the coronavirus infection, the developers noted. The work on creating the new domestic vaccine was supported by Moscow Seed Fund.
The volunteers are being screened at several clinical centers in St. Petersburg and Perm. Only healthy people aged 18-60 who previously have not had COVID-19 and who haven’t been inoculated against the coronavirus infection can participate in the trials, the developers noted.