The first group of participants in the clinical trials of the CoViD-19 vaccine was discharged from the branch of the Main Military Clinical Hospital named after Burdenko
The first group of volunteers participating in the clinical trials of the CoViD-19 coronavirus infection vaccine, conducted by the Russian Ministry of Defence together with the National Research Center for Epidemiology and Microbiology, completed her participation in research and were discharged from the branch of the Main Military Clinical Hospital named after Burdenko.
Before discharge, the volunteers underwent a control examination and passed a blood test to study the development of an immune response.
The main objective of the study for the first group of 18 people was to check the safety and tolerability of the vaccine components.
During the tests, the volunteers were under the constant supervision of medical specialists of the Main Military Clinical Hospital named after Burdenko, who conducted daily examinations of volunteers, measured blood pressure, pulse rate, body temperature, studied the condition of mucous membranes, skin integuments and other indicators, carried out the whole range of laboratory and instrumental studies provided by the test protocol and necessary to study the intensity of the immune response.
For 28 days after vaccination, the vital signs of the volunteers remained within normal limits, serious adverse events, health complaints, complications or adverse reactions were not recorded.
Available laboratory and instrumental studies allow us to confidently talk about the safety and good tolerance of the vaccine.
On the 42nd day after the first vaccination, test participants will have to return to the hospital for one day to undergo a final medical examination and diagnosis, as well as the preparation of all necessary documents.
On May 26, during a videoconference meeting with Russian President Vladimir Putin, Russian Defence Minister General of the Army Sergei Shoigu reported that the 48th Central Research Institute of the Russian Armed Forces, together with the National research center for epidemiology and microbiology named after N. Gamalei, is developing a recombinant vaccine against a new coronavirus infection.
Preclinical tests of the vaccine for toxicity, safety, immunogenicity and protective effectiveness on large and small animals were conducted at the 48th Central research Institute of the Russian Ministry of Defence.
On June 16, the Ministry of Health of the Russian Federation issued a permit to conduct clinical trials of the vaccine on volunteers at the Burdenko main military clinical hospital.
Based on the results of the final screening, the first group of experiment participants, consisting of 18 people who were vaccinated on June 18, was finally selected among the volunteers who were on two-week isolation. Nine volunteers were given one component of the vaccine, and nine more were given the second component.
After receiving initial data on the safety and tolerability of the vaccine based on the results of the survey of the first group of volunteers, the vaccine was inserted to twenty more selected volunteers on June 23. This group of experimental participants will receive the drug in a booster version-three weeks after the first vaccination, they will be given the second component of the vaccine according to indications.
The volunteers are isolated in a hospital and are constantly monitored by the most experienced specialists of the Burdenko main military clinical hospital, who have previously repeatedly participated in clinical trials of medicines, including vaccines.
The full range of laboratory and instrumental studies required by the research protocol and required to study the intensity of the humoral immune response continues.
The participants in the experiment include both military personnel of the Russian Armed Forces (officers, warrant officers, and military personnel serving under contract in the NBC protection troops and medical institutions of the Russian Defence Ministry) and civilian volunteers.
Clinical trials of the coronavirus vaccine, conducted by the Russian Defence Ministry in conjunction with the Gamalei National research center for epidemiology and microbiology, are scheduled to be completed by the end of July this year.