The Ministry of Health of the Russian Federation has granted the Gamaleya Center permission to conduct phase I-II clinical trials of a vaccine against coronavirus based on virus-like particles (VLP). The permit was published on Wednesday, February 16, in the state register of the Ministry of Health of Russia.
According to the registry, a phase I-II trial will be conducted on volunteers aged 18 to 55 years “to assess the tolerability, safety and immunogenicity of a vaccine for the prevention of COVID-19 based on VLP (particles similar to SARS-CoV-2).”
It is planned that the studies are held in seven medical institutions in St. Petersburg, Kirov, Perm, Novosibirsk region, Moscow and the Moscow region. 600 people will be subjects in the research.
“The purpose of the clinical trial is to assess the tolerability, safety and immunogenicity of the optimal dose of the vaccine in comparison with placebo for 21 days after two intramuscular shots,” the website says.
In the near future, permission should be obtained to conduct clinical trials of a therapy for COVID-19 based on monoclonal antibodies, which was developed by specialists of the Gamaleya National Research Center for Epidemiology and Microbiology. This was stated by Alexander Ginzburg, the director of the center.
The Gamaleya Center failed to find children aged 6 to 11 years old in Moscow who have never had any contact with the novel coronavirus. Therefore, it is necessary to change the protocol of clinical trials of Sputnik M vaccine for this age category.