Developer of Betuvax coronavirus vaccine announces start of clinical trials
MOSCOW. Oct 15 (Interfax) - First volunteers have received shots of the experimental Betuvax coronavirus vaccine as part of Phase I-II of its clinical trials, the Human Stem Cells Institute (HSCI) said on Friday.
"First patients received the Betuvax-Cov-2 coronavirus vaccine as part of Phase I-II of its clinical trials at the Smorodintsev Influenza Research Institute in St. Petersburg on October 15, 2021," the HSCI said.
St. Petersburg and Perm clinics have also started screening volunteers for further phases of the trials.
In line with the protocol of the trials, the first 20 of 170 volunteers will receive two shots of the vaccine, and the use of placebo is planned only at the next stage, it said.
The vaccine will be administered twice, with each shot 28 days apart.
The Russian Health Ministry has approved the start of clinical trials of the Betuvax-Cov-2 subunit recombinant vaccine on September 27. Phase I-II of the trials should be completed by August 31, 2022, as follows from information available on the state register of medicinal products.
The double blind randomized study will be held on the basis of the Smorodintsev Influenza Research Institute, the Eco-Safety Medical Center in St. Petersburg, and the Center of Professional Medicine in Perm.
The vaccine has been developed by the Betuvax company at the HSCI. The developer claims that this is the first Russian subunit coronavirus vaccine, meaning that it contains an artificially recreated fragment of the coronavirus "playing a key role in inducing an immune response." It does not contain live viruses or their vectors, and no viral material is used in its creation, and therefore, such vaccines are believed to be the safest, in the view of Betuvax.