Another anti-Covid-19 vaccine is in the running: the all-Italian one designed by Takis of Castel Romano and developed with Rottapharm Biotech of Monza has begun phase 1 testing and has been injected into the first healthy volunteer.
“I am proud to have taken part in such an important project and I hope to be able to lend a hand,” said Luca Rivolta, the 21-year-old chef who was the first to receive the new vaccine at the San Gerardo hospital in Monza, which is participating in the tests with the University of Milan-Bicocca.
Other volunteers will be vaccinated in the other two Italian centers involved in the study: the Pascale Foundation National Cancer Institute in Naples and the Lazzaro Spallanzani National Institute for Infectious Diseases in Rome. Phase 1 of the trial requires the 80 healthy volunteers to be divided into 4 groups with different doses administered with or without a booster. A race with tight stages has just begun: as is happening for all anti-Covid-19 vaccines, there will be no pauses for the Takis-Rottapharm vaccine: “Phase 1 will be attached to Phase 2: as soon as we have information on the most promising doses, we will immediately proceed with the second phase, probably between the end of August and the beginning of September on a further 240 patients,” explained Luigi Aurisicchio, CEO and Scientific Director of Takis. “Then we will move on to Phase 3, but – he noted – there is the big question mark of funding. There should be some attention on this vaccine from Italian and European institutions.” Called Covid-eVax, the vaccine elicited a strong antibody and cellular immune response in laboratory tests.
There are two new features: the first is in the technology used, different from that of other vaccines available so far, and the second is that it can be easily updated to combat variants. It also "allows you to avoid the cold chain in storage and transport", notes Aurisicchio. It is a DNA vaccine, meaning that to stimulate the immune reaction it uses a fragment of DNA that, injected into the muscle, promotes the production of a specific portion of the Spike protein, which the SarsCoV2 virus uses to enter human cells; the efficiency of the process is increased by the electroporation technique, the technique that favors the passage of DNA into cells thanks to mild and brief electrical stimuli and which was developed by the Italian company Igea.
Each of the three clinical centers involved in the study has major responsibilities for one of the three main aspects of the trial: San Gerardo in Monza, with the Phase 1 Research Center directed by Marina Cazzaniga, of the University of Milan-Bicocca, is responsible for treating the first subjects of each dose and verifying the preliminary results; Pascale in Naples has a role in expanding the number of subjects for each dose; and Spallanzani in Rome is responsible for all the laboratory tests that document the immune response and therefore the potential efficacy.
Article published on March 1, 2021 - 22pm
