The ties between Cuba and Italy’s Piedmont region were strengthened in 2020, when a brigade of our doctors provided assistance there during the worst moment of the pandemic. Relations have become even more solid with the launching of a clinical trial, Soberana Plus-Turin, the first study of this Cuban anti-COVID vaccine on the Island with volunteers from abroad, which began November 16 with vaccination of the Italian subjects.
The study has a prospective, open, no-control design, with parallel, multicenter groups, with Cuba’s La Pradera International Health Center as the principal clinical site and, in Italy, the Amedeo di Savoia Hospital, in the city of Turin.
Recently approved and evaluated by the Center for the State Control of Medicines, Equipment and Medical Devices (Cecmed), the study is proposed as an exploratory trial of the Soberana Plus vaccine, created by the Finlay Vaccine Institute (IFV), to evaluate the reactogenicity (side effects) and immunogenicity (immune response) in Italian adults, including those recovering from a mild or moderate case of COVID-19 and subjects with no history of the disease who have been previously immunized against SARS-COV-2 with vaccines used in the European country.
The study has been duly included in the Cuban Public Registry of Clinical Trials and the International Clinical Trials Registry Platform of the World Health Organization (WHO).
SCIENCE BRINGING PEOPLES TOGETHER
While waiting his turn to be medically evaluated for inclusion in the study, Simone Valli, one of 35 Italian volunteers who arrived in the country for this purpose, commented on his decision to participate in the trial, motivated, first of all, by the importance of finding solutions to confront the pandemic, while at the same time supporting Cuba in the media and economic battle surrounding its vaccines.
"We must defend Cuba and socialism, because what Cuba is doing with its public vaccines, with its brigades of doctors around the world, is only possible with socialism," stated the young activist, who has been vaccinated previously with two doses of the Pfizer immunogen.
Although 35 Italians arrived on the island with the goal of participating in the clinical research, only those meeting the inclusion criteria were selected.
Dr. Rolando Ochoa Azze, lead researcher of the Soberana Plus-Turin trial, explained that the study will include Italian adults between 19 and 59 years of age, of any sex, who give their consent to participate and meet the selection criteria.
Once the subjects have been identified, the following groups will be evaluated independently: those recovering from a mild or moderate case of COVID-19, and healthy volunteers with no history of the disease who have been previously immunized against SARS-COV-2, regardless of the platform on which it was developed, he explained.
Dr. Ochoa emphasized that this is a research study based on scientific criteria, as outlined by national Ethics Committees of both countries, which in turn are endorsed by the Piedmont Regional Ethics Committee and the Amedeo di Savoia Hospital in Turin.
"The required endorsement was obtained to conduct this study, which was also duly listed in the Cuban public registry of clinical trials and has the approval of Cecmed, which was an extremely rigorous process," the researcher added.
The study also includes an Independent Data Monitoring Committee, led by Dr. Narciso Argelio Jimenez Perez, who has extensive experience in the trials of anti-COVID-19 vaccines conducted on the island.
Regarding the observation process to determine the safety of the vaccine and the subsequent immunological analysis, Dr. Meiby Rodríguez González, Director of Clinical Research at the IFV, explained that, once the single dose of Soberana Plus has been administered, subjects remain at the same clinical site for one hour, to monitor any signs of serious adverse side effects.
Thorough check-ups of all participants will be conducted within the next 24, 48 and 72 hours, as well as on the seventh day, before returning to Italy on the tenth day following vaccination, where they will be evaluated on the 28th day, when a blood sample will be taken to compare the levels of antibodies present in their bodies with the level observed prior to their vaccination with Soberana Plus.
Soberana Plus-Turin is part of a collaborative study with Amedeo di Savoia Hospital (in which another group of subjects will also be evaluated with this immunogen), as a result of improved relations between the two nations, promoted by Italian health professionals and organizations like the Association for Cultural and Economic Exchange with Cuba.
Its president, Michele Curto, one of the volunteers who traveled to Cuba for the clinical trial, highlighted the interest shown by his compatriots in participating in the study of the Cuban vaccine.
He praised Cuba's accomplishments, having created several vaccines and candidates of its own, in the midst of so many difficulties, while at the same time emphasizing that the island’s immunogens could represent an important opportunity for Italy in its battle against the pandemic, since they are protein vaccines, economical, safe and more easily produced in the European country, from the industrial point of view.
It is expected that the results of the study will confirm the capacity of Soberana Plus as a universal booster in persons with pre-existing immunity, produced either naturally in those who have recovered from COVID-19, or via vaccination with other immunogens, regardless of their platforms.
