The Gamaleya National Research Center for Epidemiology and Microbiology will study efficacy of the Sputnik V vaccine against various coronavirus strains within the framework of cooperation with the Spallanzani National Institute for Infectious Diseases, Alexander Gintsburg, Director of the Center that developed the vaccine, told TASS on Tuesday.
"This institute [Spallanzani] probably has the most representative collection of various strains in Europe. We are ready, using an extended variant, their collection, to conduct tests of protective capabilities of Sputnik V on those strains that interest us and on those strains that are now relevant both for Italy and the EU," the scientist said.
He also said that at the initiative of the Russian Embassy, the Russian Direct Investment Fund (RDIF), as well as the Russian Healthcare Ministry, a large program of cooperation is planned between the Spallanzani Institute and the Gamaleya Center, including within the framework of fighting the coronavirus pandemic. "After three weeks of coordination, we signed a memorandum. Soon our employees will travel there to work in a number of very interesting and relevant directions, related to the vaccine and the variability of strains," he explained. "We have very good business contacts mapped out with the leadership of this institute. We are in regular touch in the video conference format," the scientist added.
Clinical trials of Sputnik V are also planned, including in combination with other vaccines against coronavirus. "Today we reported to our colleagues from the Spallanzani Institute that, in addition to those tasks that will be interesting to resolve together, we are ready to resolve another task - to provide our vaccine for trials of combined use with other vaccines. If the RDIF finances it all, then we, of course, after obtaining appropriate permits from regulatory bodies, are ready to conduct such a small but illustrative study, administering the Sputnik V vaccine to those already inoculated with other vaccines," the scientist divulged.
Earlier, the Italian Spallanzani Institute and the Russian Gamaleya Center signed a memorandum on scientific cooperation.
The document notes that the Italian institute "has one of the largest in the EU biological banks of viral agents." Additionally, the institute "has already registered <...> and legally preserves 120 live strains of SARS-CoV-2," including variants of British and Brazilian strains.
The memorandum notes that the Spallanzani Institute "will exert every effort to provide these strains to the Gamaleya Institute." On its part, the Gamaleya Institute will "exert every effort to submit biological samples (sera) from individuals who received the Sputnik V vaccine in Russia." In particular, "a possibility will be considered to submit a series of samples taken at different times - similar to those obtained from volunteers who participated in clinical trials in Russia."
It is noted that within the framework of cooperation "specific methods of conducting clinical trials will be studied that presume the use of Sputnik V on volunteers in Italy." The studies are planned to be conducted depending on the stage of approval of the vaccine by the Italian medical regulator. Preliminary trials "involve testing the vaccine on a small number of volunteers (50-100 people) with the goal of demonstrating safety and efficacy of the Sputnik V vaccine regarding certain population groups, for example, those who have not formed a steady immune response as a result of previous inoculation or those who have already received a dose of another vaccine."