The Russian Defence Ministry and the Gamalei National Research Center for Epidemiology and Microbiology are set to begin clinical trials of a Covid-19 vaccine candidate developed in the country.
Currently, the partners are making final preparations for the studies and expect to commence vaccinations in the coming days.
One group of participants will initially receive the vaccine at the end of the two–week quarantine period. The aim is to assess the safety and tolerability of the vaccine components.
Both military and civilian personnel will be enrolled for the trial. The Russian Defence Ministry noted that the parameters for the sample of volunteers have been discussed with the Ministry of Health.
Based on the data from the first group of volunteers, the remaining participants will be successively vaccinated with the vaccine components. This part of the trial is intended to evaluate the vaccine’s effectiveness and development of antibodies against SARS-CoV-2.
Prior to the human trials, the vaccine was tested for its toxicity, safety, immunogenicity and effectiveness in large and small animals at the Russian Defence Ministry’s 48th Central research institute.
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The Russian Defence Ministry said in a statement: “Every day, a set of necessary measures is carried out to monitor the main vital indicators of volunteers and study a number of special parameters.
“Blood tests for IgG and IgM antibodies, oropharyngeal smear for PCR diagnostics on Covid-19 are taken. All volunteers have a high degree of motivation, well-tolerated quarantine and preparation for the main phase of testing.”
Last month, ChemRar Group and The Russian Direct Investment Fund (RDIF) reported positive results from a multi-centre clinical trial of Favipiravir in patients hospitalised due to Covid-19.
Of the 40 patients treated with the drug, 60% tested negative for coronavirus following five days of treatment, two times higher compared to those on standard therapy.