The trial will be carried out with 132 persons in the Saturnino Lora Hospital in Santiago de Cuba’s capital to test its effectiveness, efficacy and immunogenicity.
The head of the Department of Teaching and Research of the aforementioned institution, Liudmila Risset Castro, updated that previously all the female and male gender adult subjects, healthy or with controlled chronic diseases, were rigorously assessed and the expert specified that the study will be conducted in an ambulatory way.
This first phase should conclude on February 16 and, later on, it is foreseen to develop the 2nd phase in the hospital with 600 volunteers who fulfill the aforementioned requirements to undergo such process, and whose magnitude intends to be covered through a call, which will be made, if necessary.
The Abdala vaccine candidate was achieved by researchers from the Center for Genetic Engineering and Biotechnology of the capital city and recently received the authorization for starting this phase from the Center for State Control of Drugs, Equipment and Medical Devices (CECMED), the regulatory entity, among others, of these clinical trials.
According to Granma newspaper, everything takes place on the basis of the fulfillment of the good clinical practices and with attachment to the protocol arranged by the CECMED, which stipulates, among other requirements, the surveillance on those persons to detect the development of some adversity symptoms not in accordance with the vaccine’s safety.
Currently, Cuba has four vaccination candidates – Soberana 01, Soberana 02, Abdala and Mambisa.
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