On March 3, the Northwestern Research Center for Hygiene and Public Health will begin the first phase of clinical trials of the CoronaDerm PS skin test. This was reported to Izvestia by Elena Shalukho, chief researcher at the Northwestern Scientific Center for Hygiene and Public Health.
According to her, testing will give an answer to the question of whether a person has encountered the COVID-19 pathogen, whether he has developed t-cell immunity and whether it is time to revaccinate.
“Today we are starting the first phase of clinical trials of the CoronaDerm PS drug, developed by the Research Institute of Epidemiology and Microbiology named after N.N. Pasteur Rospotrebnadzor. It involves 20 healthy volunteers who have not had COVID-19 and have not been vaccinated,” Shalukho said.
She also noted that after the wave of the coronavirus pandemic ended, it was quite difficult to find people who were not ill and not vaccinated for research.
The first phase of the study is scheduled for 2-3 weeks, the expert specified. Scientists have yet to determine how safe the drug is. In addition, scientists will study the papule at the injection site on the third day after the injection and compare the results with the response of cells in the human body.
“This study is different from what we usually do. The second phase of clinical trials is quite rare in our center. It is especially interesting for us that we are investigating a drug that has been developed for the first time, which has nothing to compare with, ”explained the SZNTs researcher.
At the end of the first phase, the same group of specialists will proceed to the second. It is designed, according to Shalukho, for March-April. It should involve 400 volunteers.
“Upon completion of clinical trials, the Pasteur Research Institute will send the drug for registration to the Ministry of Health. Then industrial replication and application will follow, ”explained the head of clinical research.
On February 16, the head of Rospotrebnadzor, Anna Popova, announced that Russia had completed work on a new test system for detecting COVID-19, which would be more sensitive and resistant to mutations.
On February 10, Rospotrebnadzor reported that Russia allowed testing a skin test that will determine whether a person has cellular immunity to the COVID-19 pathogen, the testing procedure resembles the well-known Mantoux reaction.
The injectable preparation contains an antigen to SARS-CoV-2 and is injected under the skin, the result is determined by the diameter of the papule 72 hours after the injection. A positive test indicates that the subject has cellular immunity. Negative means that you need to be vaccinated or revaccinated.
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