Havana, Jun 14 (RHC) The first phase of the anti-Covid-19 clinical trial begins this Monday in Cuba targeting children and adolescents, who will take a heterologous vaccination schedule, with two doses of Soberana 02 plus one dose of Soberana Plus.
Approved last 10th by the Cuban State Center for the Control of Medicines and Medical Devices (Cecmed), this phase I/II study to be carried out at the Juan Manuel Márquez Pediatric Hospital in the capital will be sequential, open, adaptive and multicenter, in children between the ages of three and 18 years old.
To carry it out, the sample of 350 people in pediatric ages will be divided into two groups: the first one made up of children from 12 to 18 and the second one of kids from three to 11.
The objectives of this stage are to evaluate the safety, reactogenicity and immunogenicity of the prophylactic vaccine candidates designed by the Finlay Vaccine Institute (IFV), separated by 28-day intervals, a scheme already applied to the adult population.
The approval of this trial is supported on the basis of the current epidemiological context, with the considerable increase of positive cases in the pediatric population and based on the safety and immunogenicity results shown by the vaccine candidates, said a Cecmed press release.
Evaluation in Children
The evaluation process in children is carried out to ensure in a short time their return to normality, their attendance to schools, ‘playing, walking and doing daily activities’, said the director of the center, Olga Lidia Jacobo.
Since the beginning of the pandemic on the island, a total of 20,849 infants were infected with SARS-CoV-2, the cause of Covid-19.
In this context, vaccination would play a fundamental role, since it could have a very positive effect on the containment of the progression of this disease”, the Cecmed text points out.
Dr. Meiby de la Caridad Rodríguez, director of clinical research at the IFV and representative of the center within the clinical trial, explained that the children included will do so on a voluntary basis, which will be expressed through informed consent to participate in the trial.
For subjects in the range of three to 11 years of age, the authorization of the parents or legal guardians is required, while for children between 12 and 18 years of age, the authorization of the adolescents is also required, she said.
He explained that after each injection the infants will remain one hour under surveillance at the vaccination center, after which they will have to go again every 24, 48 and 72 hours so that the specialists can check if the subjects had adverse events related to the immunization, since it is in this period of time when most of them occur.
During the following days, each volunteer will undergo medical check-ups and in total will remain approximately four months in the study, since once the third dose has been received, they will be under evaluation for 28 days, he added.
(Taken from RHC)