Human Trials Completes in Russia : COVID-19 vaccine tested on volunteers at Sechenov

The clinical trial of a vaccine against SARS-CoV-2, the causative agent of the coronavirus pandemic, is ongoing at Sechenov University. A second group of 20 healthy volunteers received the vaccine on 23 June 2020 at the Practical Research Centre for Interventional Cardiovasology. The first group (18 people) got the jab a few days earlier, on 18 June 2020.

The volunteers are males and females, aged 18 to 65. In the clinical study at Sechenov University, they receive a lyophilised vaccine—a powder from which a solution is prepared for intramuscular injection. The vaccine was developed by Gamaleya Institute, an epidemiology research centre in Moscow. The Russian Ministry of Health sanctioned the trial on 16 June. Sechenov University has been selected as the site of this clinical study because of its outstanding infrastructure and the high professional level of its medical staff.

Some participants of the trial experienced headaches and an elevated body temperature, however, these symptoms resolved completely within 24 hours after vaccine administration. Yelena Smolyarchuk, Head of the Sechenov University Centre for Expert Evaluation of Medicinal Products, is quoted in a press statement saying that such response to injection is quite typical in the case of infectious diseases, and the volunteers are again in good health. The Russian Health Ministry will make a decision on the substance effectiveness based on the results of laboratory immunoassays.

The study participants are housed in single or double wards on campus at Sechenov University. They are to spend 28 days in isolation after vaccine injection in order to protect them from exposure to other infections, and after discharging they will be monitored for 6 more months. During isolation, which may be monotonous and uneventful, the volunteers are offered psychological support. Sechenov University also provides the study subjects with sports facilities to maintain physical activity.

The COVID-19 vaccine developed by Gamaleya Institute is also being tested at Burdenko Military Hospital in Moscow, but this clinical trial uses the liquid form of the medication. The Russian Ministry of Health hopes to finalise the trials and make a decision on vaccine effectiveness before autumn.