The trial initially enrolled 18 volunteers, for whom the Covid-19 vaccine was dosed on 18 June 2020 and the second group of 20 healthy volunteers were dosed on 23 June 2020
Russia’s Sechenov First Moscow State Medical University (Sechenov University) has reportedly completed the clinical trials of the coronavirus vaccine on volunteers.
According to the Russian news agency Sputnik, the university has started the clinical study of a vaccine against SARS-CoV-2 that causes Covid-19 produced by Russia’s Gamalei Institute, an epidemiology research centre in Moscow.
The Russian Ministry of Health has granted approval for the clinical trial on 16 June.
Sechenov University medical parasitology, tropical, and vector-borne diseases institute director Alexander Lukashev said that the clinical trial was aimed at evaluating the safety of Covid-19 vaccine on humans.
The trial initially enrolled 18 volunteers, for whom the Covid-19 vaccine was dosed on 18 June 2020 and the second group of 20 healthy volunteers were dosed on 23 June 2020.
The clinical trial at Sechenov University used the lyophilised Covid-19 vaccine
The clinical trial is designed to enrol male and female volunteers, aged 18 to 65 years at Sechenov University, and receive the lyophilised Covid-19 vaccine, a powder from which a solution is prepared for intramuscular injection.
The translational medicine and biotechnology institute director Vadim Tarasov told Sputnik that the university has completed the clinical trial of the vaccine, and the first group of volunteers are planned to be discharged on 15 July and the second on 20 July.
As reported by Sputnik, Tarasov said: “Sechenov University in a pandemic situation acted not only as an educational institution but also as a scientific and technological research centre that is able to participate in the creation of such important and complex products as drugs … We worked with this vaccine, starting with preclinical studies and protocol development, and clinical trials are currently underway.”
The study participants were housed in single or double wards on campus at Sechenov University, who would spend 28 days in isolation after the vaccine is being administered, to protect them from exposure to other infections, and after discharging they will be monitored for additional six months.
Few participants of the clinical trial experienced headaches and an increase in body temperature. However, the symptoms were reported resolved within 24 hours after the vaccine was administered.
Sechenov University centre for expert evaluation of medicinal products head Yelena Smolyarchuk said in a press statement that similar response to injection is typical in the case of infectious diseases, and the volunteers have returned to good health.
Furthermore, Gamaleya Institute’s vaccine is also being tested through a clinical trial at Burdenko Military Hospital in Moscow, using the liquid form of the medication.