Vaccine trials are going stable: Russia
By Monitoring DeskWednesday – July 8, 2020
According to an official statement, all volunteers are under constant dynamic supervision of medical specialists who have experience in conducting clinical trials of medicines, including vaccines.
Specialists conduct daily examinations and interviews with volunteers, during which blood pressure, pulse, temperature are measured, auscultation is performed and the vaccination mark is examined.
The entire range of laboratory and instrumental studies provided for by the test protocol and necessary to study the intensity of the humoral immune response is carried out.
Next week, 21 days after the first vaccination, the second component of the vaccine will be introduced to the second group of volunteers.
The “booster” version of vaccination involves an additional strengthening of the body’s protective functions and an increase in the duration of protection as a result of repeated vaccination.
For reference, on May 26, this year, 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 (CRI) of the DM nuclear, biological and chemical (NBC) protection troops, together with the Gamalei national research centre (GNRC) for epidemiology and microbiology of the health ministry, 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 CRI.
On June 16, the health ministry 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.
9 volunteers were given one component of the vaccine, and 9 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 20 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 DM) and civilian volunteers.
Clinical trials of the coronavirus vaccine, conducted by the Russian DM in conjunction with the GNRC for epidemiology and microbiology, are scheduled to be completed by the end of July this year.