Clinical Trials of Russian Vaccine against Coronavirus Began

19 June 2020

GMP News

The study of two forms of a COVID-19 vaccine developed by the Gamaleya National Research Center for Epidemiology and Microbiology started on Wednesday in Russia. Two groups of 38 volunteers each are participating in the trials, the press service of the Russian Ministry of Health reported.

“The clinical trials of the COVID-19 vaccine started on June 17. The study of two vaccine forms, liquid and freeze-dried, will take place in two medical facilities in Moscow. The vaccine in the form of a solution for intramuscular injection will be tested at the Burdenko Military Hospital. The other vaccine in a powder form for intramuscular injection will be tested at the Sechenov First Moscow State Medical University. Two groups of 38 volunteers per group will participate in the trials,” the statement said.

It is noted that the potential trial participants were quarantined for two weeks at a sanatorium. All information on the procedure had been disclosed to each volunteer, including its benefits and risks, as well as trial-related inconveniences.

“After signing the informed consent and insurance paperwork, the trial participant undergoes a screening. This involves blood and urine tests, a check-up for chronic illnesses, HIV, hepatitises, coronavirus. Only after compliance to the trial inclusion criteria is confirmed, are the volunteers injected with the vaccine. The first volunteers will be vaccinated as early as June 18-19,” the press service reported.

After vaccination, all volunteers will be isolated in a clinical setting for 28 days where medical professionals will monitor their physical condition. “The entire procedure that accompanies the clinical trial is aimed at protecting the rights and safety of the trial participants. This is only the first stage of studying the effectiveness and safety of the vaccine,” the statement said.

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