The Ismaelillo clinical trial, in pediatric ages, began in the city of Camagüey, with the application of Abdala. The main researcher of the health intervention in the country with the Abdala vaccine and Head of the Virology Department of the Pedro Kourí Institute of Tropical Medicine (IPK), Dr. Sonia Resik Aguirre, commented that:
“The study is carried out in two phases, with a population of almost 600 people from Camaguey, between the ages of three and up to 18 years old.”
The sample was selected based on the proximity of the children’s residence to the nine polyclinics in the city, to avoid excess mobility at this stage, and, furthermore, with the criteria, prior study, of healthy conditions of the boys, based on their medical history, physical examination, and evaluation by the investigating pediatrician.
“In the Cuban Public Registry of Clinical Trials (RPCEC) the general characteristics of the randomized Phase I / II trial are specified, which in the first stage includes volunteers between 12 and 18 years of age, and then, It will include children from 3 to 11 years of age. In all cases, the informed consent of the parents and the consent of the adolescents are required to participate. “
“The immunization schedule will be three doses intramuscularly, every 14 days, that is, administered in the interval of zero, 14 and 28 days.”
The representative of the Clinical Research Directorate of the Center for Genetic Engineering and Biotechnology (CIGB), Dr. Zurina Cinza Estévez, who is conducting the study, conveyed the satisfaction that “Camagüey has been selected for the trial , due to the experiences accumulated in the province in other studies with vaccines in pediatric ages ”.
“We have worked here with our pentavalent vaccine, also in health studies with the application of the immunogen for poliomyelitis; In other words, they already have prestige and the personnel prepared, which gives us confidence for the results that are expected in the shortest possible time.
“The current study is carried out in compliance with good clinical practices and the established ethical and methodological rigor, with the participation of an independent data monitoring committee, made up of highly qualified professionals from outside the research sites and to CIGB, developer of the Abdala vaccine. ”
Dr. Sonia Resik also recognized the endorsement that Camagüey has:
“With extensive experience both with Cuban vaccines and in clinical trials with the World Health Organization (WHO), with a sustained work of more than 20 years and a highly qualified personnel; and this work has been recognized by the highest levels of WHO, the Pan American Health Organization (PAHO), and by our Ministry of Public Health (MINSAP) ”.
Next week the second stage of the clinical vaccine trial is scheduled, with children from 3 to 11 years old, after receiving the permission that must be issued by the Center for the State Control of Medicines, Medical Equipment and Devices (CECMED), at Same as for the start of Phase II.
Dr. Sonia Resik Aguirre, predicted the success of the Ismaelillo clinical trial with the Abdala vaccine, the results of which will favor the extension of the application to the entire child population in Cuba.