Russia (bbabo.net), - A clinical trial of a nasal vaccine for the prevention of COVID-19 manufactured by Generium has begun in Moscow. A clinical trial of a nasal vaccine developed by N.F. Gamaleya. This was announced by Anastasia Rakova, Deputy Mayor of Moscow for Social Development, Head of the Operational Headquarters for Controlling and Monitoring the Situation with Coronavirus in Moscow. She said:
“Today, on the basis of six metropolitan polyclinics, we began a clinical trial of a nasal vaccine developed by Generium. A total of 660 people will take part in it: about 400 of them in Moscow medical institutions, the rest in 11 centers throughout Russia. This vaccine is identical in composition of the active ingredients of "Sputnik V", intended for intramuscular injection. Earlier, on the basis of our polyclinics, a study of the nasal vaccine of the Institute named after N.F. Gamaleya started. We are pleased to be one of the key platforms for studying vaccines against COVID-19. The city is interested in cooperation with different manufacturers to help increase the availability of vaccines in civilian circulation.
The clinical study is being conducted at six Moscow polyclinics - No. 2, No. 52, No. 36, No. 68, No. 115, No. 210, as well as in 11 centers in Moscow, Nizhny Novgorod, St. Petersburg, Saransk, Saratov, Smolensk, Yaroslavl.
"JSC Generium has developed one of the concepts of the intranasal route of administration of the Sputnik V vaccine, the production conditions and quality characteristics of which will not differ from the intramuscular form of the drug," said Daniil Talyansky, General Director of JSC Generium.
The study will examine the safety and efficacy of the nasal vaccine. All participants in the study will be divided into two groups, each volunteer on the 1st and 21st day will be given an intramuscular injection of the drug into the nose. One group will have the study vaccine sprayed and a placebo given by injection, and the other group will have placebo sprayed and injected with Sputnik V. Volunteers will be under medical supervision for 365 days.
Before the start of the study, all participants undergo a medical examination. This will help determine the initial state of the body and avoid the development of possible adverse events.
Any healthy citizen aged 18 to 60 who has not been vaccinated against COVID-19 and has not been ill with COVID-19 in the last 6 months, and has not been in contact with a sick person with COVID-19 in the last 14 days, can become a participant in the study. You can apply for participation in this clinical trial on the basis of Moscow city polyclinics by mail.
Recall that earlier in Moscow, a clinical trial of a nasal vaccine for the prevention of COVID-19, developed by the N.F. Gamaleya. The study is conducted on the basis of four medical organizations, including two Moscow polyclinics: city polyclinic No. 2 and diagnostic center No. 5, as well as at the First Moscow State Medical University. THEM. Sechenov of the Ministry of Health of Russia and LLC "NIC ECO-safety".
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