COVID vaccines clinical trial for children starts in Cuban central province

CAMAGUEY, Cuba, Jul 13 (ACN) The Ismaelillo clinical trial with the Abdala vaccine will begin this Thursday in the capital city of Camagüey. It will be carried out in two phases and will include children from three to 18 years of age, and then the immunogen will be applied to children in Cuba.

After previous analysis of the health status of the minors, the vaccination scheme will be three doses every 14 days, intramuscularly, and two formulations with different potencies (25 micrograms and 50 micrograms) will be applied, explained Dr. Sonia Resik Aguirre, principal investigator of the Abdala vaccine studies in the Antillean country.

Phase I of the trial will involve children between 12 and 18 years of age selected according to the inclusion criteria, in addition to the informed consent of their parents and the adolescents' assent to participate.
The second stage of the Phase I trial is scheduled for the following week, which will cover children from three to 11 years old, after the permit to be issued by the Center for State Control of Medicines, Equipment and Medical Devices (CECMED), as in the case of Phase II, which will be larger, the expert said.

She affirmed that the doses of the Abdala vaccine -first one developed in Latin America-, for the Ismaelillo trial are already in Camagüey, the necessary resources are in place, the health personnel received training, as well as the teams made up by experienced people and a group of monitors.

Resik Aguirre, a scientist from the Pedro Kourí Tropical Medicine Institute, predicted the success of the process, the results of which will be announced in October and will favor the extension of Abdala's application to the child population throughout Cuba.

Dr. Zurina Cinza Estévez, chief monitor of the Ismaelillo clinical trial, commented on the ethical and methodological rigors of the study, which involves the participation of an independent data monitoring committee composed of highly qualified professionals external to the research sites and the Center for Genetic Engineering and Biotechnology (CIGB), developer of Abdala.

The clinical trial is expected to cover around 600 children, which will allow for greater safety in the final result, and boys will be chosen from urban areas near the polyclinics of the capital of Camagüey, where nine vaccinatories will operate for this purpose.