Anti-Covid-19 intervention trial with Abdala to begin in Cuba

Edited by Jorge Ruiz Miyares
2021-03-29 08:35:57

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, March 29 (RHC)-- The second anti-Covid-19 intervention trial in Cuba is beginning Monday with the vaccine candidate Abdala with 124,000 volunteers, among them health workers and the biopharmaceutical sector.

Designed by the Center for Genetic Engineering and Biotechnology (CIGB), this product will be administered to volunteers from 19 to 80 years old, from the AICA Pharmaceutical Laboratories, the National Center for the Production of Laboratory Animals, and July 26 Teaching Polyclinic.

Also included are staff from the Immunoassay Center, the Luis Díaz Soto Central Military Hospital, the Center for Medical and Surgical Research,  the Center for Scientific Research, and the different venues of the Roberto Escudero pharmaceutical laboratories in the Cerro municipality.

Standard in clinical-epidemiological studies, the controlled intervention trial aims to evaluate the direct and indirect effects of vaccination with the candidate designed by the CIGB in population groups with a high risk of contracting the infection and dispersing the contagion of Covid-19.

The research leaders seek to demonstrate the direct and indirect effects on the prevention of symptomatic disease, assess the effect in preventing severe disease,  and test the consequences of the injectable on mortality from SARS-CoV-2.

Vaccination with Abdala at this stage will consist of three doses and will seek to reduce symptomatic infection among those vaccinated by 60 percent 14 days after the third dose is administered.

The test aims to test whether it reduces severe disease and mortality by 80 percent and the overall burden of incidence in immunized and non-immunized patients with high coverage by 50 percent.

The period to complete the inclusion of the volunteers is scheduled until April 10. Individuals previously injected with an anti-Covid-19 candidate will not be able to participate, nor those with a history of previous infection or allergy to any of the product's components.

Abdala is in phase III of clinical trials with a sample of 48 thousand volunteers from three eastern provinces of the country: Santiago de Cuba, Granma, and Guantanamo.



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