The Center for the State Control of Medicines, Equipment and Medical Devices (CEDMED), today authorized two clinical studies, the first is an exploratory study with the Soberana Plus vaccine, to evaluate its reactogenicity and immunogenicity in a group of Italian volunteers convalescent from COVID-19, and in another group with no history of this disease, previously immunized with other anti-SARS-CoV-2 vaccines.
This trial will be conducted in a first stage at the International Health Center “La Pradera” in Cuba and will continue at the Hospital “Amadeo di Savoia” in Turin in Italy.
The second study will include health workers and BioCubaFarma, who will be administered a booster dose with Soberana 01, with the aim of demonstrating the non-inferiority of this vaccine candidate with respect to the Soberana Plus vaccine, in relation to its ability to reactivate the immune response between 5 and 6 months after the first vaccination.
The immune response will be evaluated between 14-28 days after administration and the duration of protection over time for a minimum period of 6 months.
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