The Finlay Vaccine Institute, an institution that developed the Soberana series vaccines, proposes a clinical study with the Soberana Plus vaccine, to evaluate its reactogenicity and immunogenicity in volunteers from Italy: those who are convalescing from COVID-19, as well as in subjects with no history of this disease, but previously immunized with one of the SARS-CoV-2 vaccines used in that country.
This is how the Finlay Institute of Vaccines and BioCubaFarma reported on their website. Finlay also adds that it is a prospective, open, uncontrolled, parallel group, multicenter study. The Main Clinical Site will be the La Pradera International Health Center, in Cuba, and in Italy the Amadeo di Savoia Hospital in the city of Turin.
Like any clinical study, it was evaluated and approved by the State Center for Medicines, Equipment and Medical Devices (CECMED) of Cuba, and duly included in the Cuban Public Registry of Clinical Trials and the International Platform of Registry of Clinical Trials of the World Organization Of the health.
On the other hand, the national regulatory authority (CECMED) has authorized the emergency use of this vaccine, which has been used not only in clinical studies, but also in massive vaccination campaigns: in convalescents, as a third dose of heterologous schedules and as doses reinforcement.
The proposed study is based on a collaborative study with the Hospital “Amadeo di Savoia”, which evaluated sera from Cuban volunteers vaccinated with Soberana Plus, and in which it was shown that it was capable of inducing neutralizing antibodies against alpha variants, beta and delta virus.
Volunteers from Italy, of any sex, between the ages of 19-59 years, who give their consent to participate and who meet the selection criteria, will be included in this trial. A dose of the Soberana Plus vaccine will be applied to them in Cuba. Adverse events will be monitored for 1 hour of observation after immunization at the clinical site, followed by active and passive surveillance with outpatient follow-up up to 28 days later. A serum sample will be taken before vaccination and 28 days later to evaluate the immune response induced by the vaccine: by determining the levels of specific anti-RBD antibodies and the in-vitro inhibition of the binding of RBD to its ACE2 receptor in Cuban institutions, as well as the neutralization against different variants of the virus, a study to be carried out in Italy.
We hope that the results of this study confirm the ability of Soberana Plus as a universal booster in people with pre-existing immunity, either naturally, as they are convalescing from COVID-19, or vaccinated with other vaccines, regardless of their platform.