A group of 35 Italian citizens is in Cuba these days to participate in a clinical trial called 'Soberana Plus Turin' which involves an exploratory study using a Cuban vaccine candidate.
The Center for the State Control of Drugs, Materials and Medical Devices (Cecmed) of Cuba indicated that this study was designed to evaluate the reactogenicity and immunogenicity of Soberana Plus on Italian volunteers recovering from Covid-19 in mild or moderate form, and on other healthy people who have completed an immunization scheme with foreign vaccines licensed in Europe, such as Johnson & Johnson, Moderna, Pfizer, or AstraZeneca.
The tests, Cecmed specified, are already underway, in collaboration with the Cuban Instituto Finlay de vacunas in the La Pradera international clinic in Havana and will continue in the Amedeo di Savoia hospital in Turin.
Volunteers will receive a third dose of the Cuban vaccine, and in a statement Cecmed indicated that "one of the objectives of the study is to demonstrate that Soberana Plus is capable of accompanying any vaccine developed so far".
Once the reinforcement dose of Soberana Plus has been received, the volunteers will return to Italy after an observation period to follow the second part of the study in the Turin hospital.
"In an increasingly post-emergency perspective, the completion of the development of protein vaccines such as SoberanaPlus - comments Giovanni Di Perri, director of the Infectious Diseases University Clinic of the Amedeo di Savoia Hospital - will expand the options available to control strategies for a long time term of Covid-19, aimed at creating and maintaining a stable protective screen against the most serious clinical consequences of the infection ".
According to Di Perri, "an element of particular interest in this initiative is represented by the conventional structuring of the vaccine, that is the absence of genetic material, be it mRNA or proviral DNA. For those whose refractoriness to current vaccines is precisely represented by their contained in nucleic acids, the development of vaccines such as Soberana plus may be a more welcome solution, thus ultimately helping to expand the percentage of the population protected by vaccination. Preliminary results seem extremely promising in terms of neutralizing antibody production and hopes that the stages still to be covered, thanks to the Italocuban association, can proceed swiftly ".