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January 26, 2022, 16:48

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Photo by D. Grishkin. Press Service of the Mayor and the Government of Moscow

The first two phases will involve 400 volunteers.

A clinical trial of the nasal vaccine against COVID-19 Sputnik has begun in Moscow. The first two phases will involve 400 volunteers, the first of whom have already been vaccinated. This was reported Anastasia Rakova, Deputy Mayor of Moscow for Social Development, Head of the Operational Headquarters for Control and Monitoring of the Coronavirus Situation in Moscow.

“Clinical studies of the nasal vaccine have begun, they are taking place in Moscow and St. Petersburg. In Moscow – on the basis of Sechenov University and two city polyclinics. The nasal vaccine is the same “Sputnik V” two-component, in the same dosage, only in a different form – in the form of a nasal spray, which is also administered twice with an interval of 21 days. The research has already begun, and the first participants have received the appropriate vaccines,” the Vice Mayor said.

During the first two phases of the study, experts will study the safety and immunogenicity of the drug (the ability to produce antibodies against the virus). To do this, the participants will be divided into four groups, which will be administered a combination of the two components of the vaccine and a placebo in different combinations.

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 named after I.M. Sechenov and LLC “NIC “Eco-safety””.

Any healthy citizen of Russia over 18 years of age who has not been vaccinated against COVID-19 and has not been ill with it in the last six months, and has not been in contact with sick people in the last 14 days, can become a participant. Before the start of the study, all participants undergo a medical examination: in addition to taking an anamnesis, it will include an assessment of the main vital signs, an ECG, a blood test for the level of antibodies to a new coronavirus infection. This will help determine the initial state of the body, as well as avoid the development of unwanted reactions and complications.

The first participants have already begun to undergo medical examinations, but you can still join the study. To do this, you need to apply by e-mail: vacspray@zdrav.mos.ru.

The study will last 180 days, during which participants will visit the research center in person and communicate with doctors by phone. Specialists will assess the patient’s vital signs and compare changes in the patient’s condition with those of the previous visit, as well as take blood for research. All volunteers will keep a self-observation diary.

Organizer — National Research Center for Epidemiology and Microbiology named after N.F. Gamaleya of the Ministry of Health of Russia.

EDITOR’S NOTE: This article is a translation. Apologies should the grammar and or sentence structure not be perfect.

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