HAVANA, Cuba, Sep 4 (ACN) After 40 persons have been vaccinated, SOBERANA 01 continues on the path of demonstrating its safety, posted on Twitter Yury Valdes Balbin, deputy director of the Finlay Institute of Vaccines (IFV), the leading center of the Cuban vaccine candidate's project against COVID-19.
At the IFV's Clinical Trial Coordination Center we evaluated the progress of the process, all under a high standard proven by two days of inspection, Valdes stated.
The Cuban Public Register of Clinical Trials defines SOBERANA 01 as a randomized, controlled, adaptive and multicenter study, to assess the candidate's safety, reactogenicity and immunogenicity in a two-dose scheme.
The sample will include 676 volunteers between ages 19 and 80, without clinically relevant disorders.
The study should be completed on January 11, 2021, and the results would be available on February 1, to be published the 15th of that month.