Clinical trial Ismaelillo-Pediatría with Abdala vaccine approved

Clinical trial Ismaelillo-Pediatría with Abdala vaccine approved
Fecha de publicación: 
5 July 2021
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The Center for State Control of Medicines, Equipment and Medical Devices (CECMED) approved today the clinical trial Ismaelillo-Pediatría with the anti-COVID-19 vaccine candidate Abdala. The trial is planned to be carried out in the province of Camaguey.

The study is a phase I/II, sequential, without placebo, and includes 600 volunteer children aging 3-18 years old, who are going to three doses at 14-days intervals each (zero-14-28).

The study will test two strengths of the product, 25 and 50µg, as the immune system of this specific population needs lower amount of immunogenic to generate protective antibodies against the virus SARS-Cov-2.

In the first stage, teenagers aging 12-18 years old will be immunized and once confirmed the medicine safety — by blood tests — children aging 3-11 years old will get vaccinated.

As the rate of infected children continues to grow — more than 200 confirmed cases in the last 15 days — CECMED authorized the beginning, from July 5th on, of the clinical trial with Abdala, vaccine candidate with a 92,28% efficiency rate in the prevention of the symptomatic disease, according to the results of the clinical trial in adult population.

The regulatory entity took into account, indeed, the evidence of security and immunogenicity of the population, promoted by the Center for Genetic Engineering and Biotechnology (CIGB).

It also pointed out, likewise, that the protocol introduced by the scientific institution met the ethical requirements and of good practices demanded by this sort of study, according to international bodies.

Marta Ayala, general director of CIGB, confirmed at the most recent Mesa Redonda TV Program that Dr. Sonia Resik, from the Pedro Kouri Institute of Tropical Medicine (IPK), will be the lead researcher. She also said that Camaguey was selected for the development of this process due to the high readiness of the province health care system in clinical trials on pediatric ages such as the anti-polio vaccine as well as the conditions of its immunization clinics.

The approval of Ismaelillo-Pediatría coincides with the 35th anniversary of the CIGB foundation, on July 1st 1986, by Commander in Chief Fidel Castro Ruz.

In the last 10 days, the entity welcomed two news that ratify the scientific and technical skill of its personnel: the efficiency of Abdala, top-3 among the most efficient anti-SARS-Cov-2 vaccines worldwide, and now the green light to the clinical trial in children and adolescents.

After this approval, Cuba now boasts two clinical trials targeting pediatric ages: Soberana-Pediatría, from the Finlay Vaccine Institute and Ismaelillo-Pediatría from CIGB.

CECMED guarantees safety, protection, rights and benefits of subject involved in any of the stage of the clinical trial.

It guarantees the proper certification — as set by Good Clinical Practices and the Verification Program to Clinical Trials— of regulations and technical rules in use.

Translated by Sergio A. Paneque Díaz / CubaSí Translation Staff

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