MIL OSI Translation. Region: Russian Federation –
All volunteers are under the constant observation of medical specialists that have experience conducting clinical trials of medicinal products, including vaccines. Specialists conduct daily inspections and surveys of volunteers, which measured blood pressure, pulse, temperature, carried out auscultation and inspection of the place of administration of the drug. Provides a full range of laboratory and instrumental studies, under the Protocol of testing and required for the study of the intensity of the humoral immune response.
Next week, for 21 days after the first vaccination, the volunteers of the second group will be introduced the second component of the vaccine. “Booster” option of vaccination requires additional strengthening of protective functions of the organism and increase the duration of protection as a result of repeated drug administration.
26 may, in the course of the meeting via videoconference with Russian President Vladimir Putin, Minister of defense of the Russian Federation General of the army Sergei Shoigu reported that 48 Central research Institute of NBC defence troops of the Ministry of defence in cooperation with the National research centre of epidemiology and Microbiology named after N. F.Gamalei of the Ministry of health launched the development of a recombinant vaccine against the new coronavirus infection.
Preclinical testing of vaccine toxicity, safety, immunogenicity and protective efficacy on large and small animals was held on the base 48 of the Central research Institute of the Ministry of defense of Russia.
On 16 June the Ministry of health of the Russian Federation granted permission to conduct clinical trials of the vaccine on volunteers at the Main military clinical hospital named after N. N. Burdenko.
The results of the final screening among those on a two-week isolation volunteers was held the final selection of the first group of participants consisting of 18 people that June 18 had been vaccinated. Nine volunteers entered one component of the vaccine, nine the second.
After receiving the results of the survey of the first group of volunteers the primary data on the safety and tolerability of the vaccine, June 23 vaccine was introduced twenty pass screening volunteers. This group of participants will receive the drug in booster version – three weeks after the first vaccination they by testimony to be introduced the second component of the vaccine.
Volunteers are isolated in a hospital and are under the constant supervision of the most experienced experts of the Main military clinical Burdenko hospital, has repeatedly participated in the clinical trials of medicinal products, including vaccines.
Continues conducting the entire spectrum of laboratory and instrumental examinations prescribed by the study Protocol and necessary for the study of the intensity of the humoral immune response.
The participants of the experiment includes members of the Armed Forces of the Russian Federation (officers, warrant officers, military men passing military service under the contract in armed forces NBC defence and medical institutions of the Ministry of defense of Russia) and civilian volunteers.
Clinical studies of vaccines against coronavirus, conducted by the defense Ministry together with the National research centre of epidemiology and Microbiology. N. F.Gamalei, will be completed by the end of July.
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EDITOR’S NOTE: This article is a translation. Apologies should the grammar and/or sentence structure will not be perfect.