Soberana Plus vaccine candidate to start Phase II clinical trial

HAVANA, Cuba, Apr 11 (ACN) Cuba's Center for State Control of Medicines, Equipment and Medical Devices (CECMED) approved the Phase II clinical trial of the Cuban anti-COVID-19 vaccine candidate Soberana Plus.

As reported Friday on social networks by Cuba's Biotechnological and Pharmaceutical Industries Group (BioCubafarma), the trial will be conducted in parallel groups, placebo-controlled and double-blind, and will be sequential, multicenter, adaptive and randomized, in order to evaluate the safety, reactogenicity and immunogenicity of a dose of Soberana Plus in COVID-19 convalescents.

Biocubafarma points out that the study will be conducted at the Institute of Hematology and Immunology as the main site and at the National Center for Sexual Education.

Cuban convalescent adults of both sexes, aged 19-80 years, with a history of mild or moderate COVID-19, or asymptomatic infection, will participate in this phase.

The authorization of the national regulatory agency is based on the results of the Phase I clinical trial of Soberana Plus, which showed that this candidate is capable of inducing high titers of neutralizing antibodies in convalescents.

Cuba has five anti-COVID-19 vaccine candidates: Soberana 01, Mambisa, Soberana Plus, Soberana 02 and Abdala, the last two already in Phase III clinical trials.

Soberana Plus, developed by the Finlay Vaccine Institute, is the first vaccine in the world for convalescent COVID-19 patients to enter clinical trials.