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Saturday, June 12, 2021

Phase I of clinical trial for Soberana 02 in pediatric ages begins next week



Havana, Jun 12 - About 25 volunteers, between the ages of 12 to 18, will receive next Monday the first dose of the vaccine candidate Soberana 02, as part of the beginning of the phase I / II clinical trial in pediatric ages, according to Dr. Meiby de la Caridad Rodríguez González, Director of Clinical Research at the Finlay Vaccine Institute (IFV).

Recently authorized by the Center for the State Control of Medicines, Equipment and Medical Devices (Cecmed), the clinical trial in pediatric population aims to evaluate the safety, reactogenicity and immunogenicity of prophylactic anti-SARS-VOC vaccine candidates -2, in a heterologous scheme of two doses of Soberana 02 and a third with Soberana Plus in Cuban children and adolescents, by the intramuscular route and at intervals of 28 days between each dose.

The trial, called Sovereign-Pediatrics, will be a phase I / II study, sequential during phase I, open label (without placebo), adaptive and multicenter. Phase I will take place only at the Juan Manuel Márquez Pediatric Hospital, while phase II will be extended to other clinical sites in the capital.

The IFV specialist explained that 50 volunteers, children and adolescents, will participate in phase I, and it will be divided into two sequences. The first will be held with 25 adolescents between 12 and 18 years of age. Once the safety in this group has been demonstrated, a report will be issued to Cecmed, in which the passage to sequence two must be authorized, which will be carried out with children from three to 11 years old, he said.

With this phase I, he said, the aim is to evaluate the safety and reactogenicity of the antigen in this age group. Meanwhile, phase II will be expanded to a universe of 300 subjects, and its purpose will be to analyze the immunogenicity of the vaccine candidate.

Rodríguez González reported that this Friday the first adolescent volunteers were recruited at the Juan Manuel Márquez Hospital, who must meet the selection criteria and have previously given consent for participation and assent.

Regarding the immunogen, the IFV researcher pointed out that Soberana 02 has developed phase I and II studies and the phase III clinical trial in adults is underway, where no serious or severe adverse events related to the investigational product have been reported.

In addition, he recalled that it is developed on a very safe and well-known technological platform, that the IFV has worked for more than 15 years for various vaccine candidates and that it is incorporated into vaccines of the National Immunization Program that are administered to children.

Referring to the need to start this trial in pediatric populations, he emphasized that vaccinating minors is essential to achieve high immunization coverage and impact the transmission of SARS-COV-2, which, especially in Cuba, already accounts for more than 20 thousand infants and adolescents infected with COVID-19, with the unfortunate loss of two human lives and several serious, critical or sequelae cases.

He also underlined that the clinical trial about to start has an Ethics Committee, with the monitoring of the National Coordinating Center for Clinical Trials (Cencec) and with the rigorous supervision of Cecmed. (Text and photo: Granma)