Soberana Plus, a vaccine created by the Finlay Vaccine Institute, for those who have overcome this disease, in addition to having an authorization for use in emergency in the adult population, was green-lighted for a study in Cuban patients between two to 18 years of age.
The vaccine is used as a booster in the immunization scheme consisting of two doses of Soberana 02 plus one of Soberana Plus and has demonstrated an increase in the neutralizing response in convalescent Covid-19 patients and an excellent safety profile.
The phase I / II clinical trial in pediatric ages, adaptive, without placebo, will be launched, with 530 volunteers between the ages of two and 18 from the provinces of Havana and Cienfuegos as sample, according to the organizers.
Forty patients will be evaluated at the Juan Manuel Márquez Hospital in Havana during the first stage.
They will be divided into two groups of 20 (2-11 years and 12-18), which in turn, will again be separated in those who are asymptomatic and patients with manifestations of the disease.
The head investigator, Dr. Rinaldo Puga, explained that all the patients will be actively followed up 24 hours, 48 and 72 hours after administering the vaccine in order to evidence any possible reactions. Blood will be taken at random at 14 and 28 days for clinical-immunological analysis and also to study the immunological variables of the process.