Russian Ministry of Defence, together with the National Research Centre for Epidemiology and Microbiology named after N. Gamaleya, has successfully completed the phase of clinical trials of a vaccine against coronavirus
On the morning of July 20, the second group of 20 volunteers was discharged from the military hospital.
Before discharge, the volunteers in accordance with the study protocol underwent a final examination and passed control blood tests.
The available test results unambiguously show the development of an immune response in all volunteers as a result of vaccination.
No side effects, complications or undesirable reactions, health complaints from the volunteers at the time of discharge were identified.
The data of daily examinations and interviews, instrumental and laboratory diagnostics accumulated during clinical trials will be transferred for processing to the National Research Centre for Epidemiology and Microbiology named after N.Gamaleya in order to comprehensively assess the dynamics and specificity of the immune response and prepare for state registration of the vaccine preparation.
At the same time, to confirm the achieved positive effect, safety and tolerability of the vaccine, all volunteers on the 42nd day after the first vaccination will again undergo a control examination.
Clinical trials of the vaccine on volunteers at the Russian Ministry of Defence were carried out in full compliance with the current legislation and scientific methodology, without any attempts to shorten the study time to avoid the risks of its use in the future.
Throughout the study, the volunteers were under the continuous supervision of medical specialists at the Burdenko Hospital, who have extensive experience in clinical trials of drugs.
The head of the Main Military Clinical Hospital named after N.Burdenko, Major General Yevgeny Kryukov, expressed his gratitude to the servicemen and civilian volunteers who entrusted their health for the experiment, showed steadfastness and endurance, being in isolation for more than 40 days, and also thanked them families for patience.
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. The main objective of the study for the first group of 18 people was to check the safety and tolerability of the vaccine components.
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.