As reported by correspondent “RG” in the military, in full accordance with the Protocol of clinical studies on the 42nd day after the first vaccination, volunteers returned to the hospital from the army and have undergone a thorough medical examination and diagnosis.
the results of the research clearly showed the presence in all subjects of an explicit immune response in vaccination. No side effects or abnormalities in the organism of volunteers have not been identified. “Thus, the available data of laboratory and instrumental studies allow to speak about safety and good tolerability of the vaccine created by the National research centre of epidemiology and Microbiology named after N. F.Gamalei, together with the Ministry of defense of Russia”, – said the Agency.
It said that in the course of the experiment, which lasted from 3 June to 20 July, the volunteers were under continuous supervision of medical specialists of the Burdenko hospital, with extensive experience conducting clinical trials of medicinal products.
Recall that on may 26, defense Minister Sergei Shoigu reported to the President that in the 48th Central research Institute of radiation, chemical and biological defense cooperation with the National research centre of epidemiology and Microbiology named after N. F.Gamalei develop a recombinant vaccine against the new coronavirus infection. Her preclinical studies on toxicity, safety, immunogenicity and protective efficacy conducted on large and small animals on the basis of military research Institute. They proved to be successful. Only after that on 16 June the Ministry of health issued a permit for clinical trials of a new vaccine on volunteers.
participants of the experiment began as the military (officers, warrant officers, contract servicemen of the NBC troops and military health care providers) and civilian volunteers. As a base for the experiment were chosen hospital named after N. N. Burdenko.
the results of the final screening among those on a two-week isolation volunteers took the first group of participants is 18. On 18 June they were vaccinated. Nine were introduced one component of the vaccine, the rest second. The main objective of the study the first group was to test the safety and tolerability of the components of the new drug. After receiving the results of their examination of primary data, June 23 the vaccine was introduced twenty volunteers: they tested the efficacy and immunogenicity of the vaccine. The second group of participants received the drug in a “booster” variant – three weeks after the first vaccination they were introduced the second component of the vaccine.
“For clinical trial volunteers weretonirovany in hospital and were 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,” – said in the defense Ministry. They added that the subjects carried out the whole range of laboratory and instrumental examinations prescribed by the study Protocol and necessary for the study of the intensity of the humoral immune response.
the defense Ministry stressed that the final clinical study of a vaccine against coronavirus is scheduled for completion this month.
