Gamaleya Federal Research Center for Epidemiology & Microbiology has successfully completed the phase of clinical trials of a vaccine against coronavirus infection. The clinical trials were carried out in full compliance with the current legislation and scientific methodology.
Clinical trials of a vaccine against coronavirus were carried out with the participation of volunteers at Burdenko Main Military Clinical Hospital of Ministry of Defence of the Russian Federation.
On July 20, the second group of 20 volunteers was discharged from the hospital. In accordance with the research protocol before discharge the volunteers underwent a final examination and passed blood tests. The test analysis reflected the development of an immune response as a result of vaccination in all cases.
The vaccine trials were carried out in full compliance with the current legislation and scientific methodology, without any attempt to shorten the clinical trials period.
During the trials there were not noticed any side effects, complications or undesirable reactions, health complaints. To confirm the achieved positive effect, safety and tolerability of the vaccine, all volunteers will again undergo a control examination on the 42nd day after the first vaccination.
The vaccine created on the platform that was previously used for development of two Ebola vaccines and the Middle East respiratory syndrome vaccine. The platform's capabilities will allow long-term maintenance of the protective titer generated after immunization.
The data obtained during the tests will be transferred to the Gamaleya Federal Research Center for Epidemiology & Microbiology for processing and preparation of all necessary documentation for state registration procedures.