Soberana clinical trial in children between three and eleven years of age to start

HAVANA, Cuba, Jun 25 (ACN) The first clinical trial in children and adolescents, named Soberana-Pediatrics, will start next Monday with the inclusion of the second group of volunteers between the ages of three and 11, after it demonstrated its safety in the evaluation of the first 25 adolescents who received the first dose.

Yuri Valdés Valdín, deputy director of the Finlay Vaccine Institute (IFV), said at a press conference that 24, 48 and 72 hours and one week after the immunization, a follow-up was carried out; based on these results, a report was prepared so that the Center for State Control of Medicines, Equipment and Medical Devices (CECMED) could approve the inclusion of the rest of the volunteers.

He said that next Monday Soberana 02 will be applied to the selected subjects, who will also receive another dose of the immunogen and one of Soberana Plus in the three-dose schedule with an interval of 28 days.

Soberana-Pediatrics has a Phase I/II design and after CECMED's authorization, the sample may be expanded to reach another 150 adolescents between 12 and 18 years of age, a process that will also begin next week, said the researcher.

IFV specialists have explained that this is an open study because it will not use placebo, but rather all those involved will receive the vaccine candidates, while it is adaptive, which implies making modifications without biases in the sample size or other design elements.

It is also multicenter as it will be developed in several clinical sites, in the first phase it will be at the Juan Manuel Márquez Pediatric Hospital and in the second phase it will reach primary health care with the inclusion of several polyclinics.

Soberana-Pediatrics involves 350 children and adolescents, 50 in phase I and 300 in phase II, stages that will be developed in a staggered and overlapping manner, complying with the strict ethical protocol, good clinical practices and with the informed consent of parents or legal guardians and in the case of adolescents and young people also their assent.

The study covers that number of subjects because the purpose is to satisfactorily cover the immunogenicity element, so as not to have to perform a phase III, in which one of the requirements is to include placebo.

Vaccinating children, adolescents and young people is essential in order to achieve high vaccination coverage and protect them from the high number of SARS-CoV-2 infected cases in the country.