Phase 3 clinical trial and observation of the first new coronal vaccine in Russia

Janis logunov, deputy director of Russia’s National Research Center for epidemiology and microbiology, said in Moscow on the 18th that the third phase of the “satellite V” new coronal vaccine study carried out by the center included three phases of clinical trials and observational studies. In the previous trials, the geometric average titer of antibodies vaccinated by volunteers exceeded 1:14000.

satellite V is the first new coronal vaccine in Russia, which was registered on the 11th. The Russian news agency quoted rogunov as saying that the “gamaliya” center is conducting a third phase study on satellite V, which is composed of two parts: one is a three-phase clinical trial with 2000 volunteers, which aims to evaluate the ability of the vaccine to elicit immune response; the other is an observation study involving 28000 volunteers to evaluate the effectiveness of the vaccine in preventing the new crown And to monitor the possible reactions after vaccination.

in addition, Russian media reported on the 17th that the phase III clinical trial of “satellite V” vaccine began on August 12, and the “gamaliya” center is revising the agreement document for 28000 volunteers to participate in the observation study, with a view to launching the study, which is expected to last for 4 to 5 months, in the next week.

according to logunov, each volunteer participating in the third phase of the study will use a mobile app with QR code to report their feelings after vaccination to the relevant hospitals, which will record all adverse reactions after vaccination.

according to the information on the website of Russian national drug catalogue, the registration of “satellite V” vaccine is valid until January 1, 2021. Rogunov said that the above registration is a “temporary registration” given by the Russian Ministry of health. “The purpose of the registration is to give groups with high risk of new coronal infection the opportunity to vaccinate the vaccine in the third phase study, so as to prevent them from becoming severe patients with new coronal diseases or even death”. Once abnormal conditions occur after vaccination, the registration can be cancelled at any time.

logunov stressed that the purpose of the third phase of the satellite V vaccine study was to evaluate the safety and efficacy of a randomized controlled trial involving a large number of volunteers. “This study is necessary to obtain a large number of statistical data to determine all trial parameters of the satellite V vaccine and to obtain a ‘permanent registration’ in the future.”

he said that 38 volunteers each participated in the phase 1 and phase 2 clinical trials of the “satellite V” vaccine, ranging from 18 to 60 years old. The geometric mean titer of antibody in the volunteers was more than 1:14000, and there was no fever, pain and other adverse reactions expected by the researchers.

according to Russian media reports, 17 scientific research institutions in Russia are currently developing at least 26 new coronal vaccines, among which “satellite V” is the fastest. The phase 1 and phase 2 clinical trials of the vaccine were completed on July 15 and August 3 respectively, which initially met the safety and efficacy standards of Russian vaccine. BEAUTY&SKIN CARE