Development of the Abdala Vaccine Candidate in Cuba.
In our cuntry, Cuba, the phase II clinical trial of the vaccine candidate Abdala (CIGB 66), developed by the Center for Genetic Engineering and Biotechnology (CIGB), began this Monday, February 1st, at the Saturnino Lora Hospital, in the city of Santiago de Cuba. The results of the phase I study, which began on December 7, showed that the safety and reactogenicity profile of the immunogen was favorable for the two doses of the vaccine candidate studied, which made it possible to accelerate the start of this new stage.
Over the next few weeks, about 760 volunteers will be immunized, with the particularity that in this second phase, in addition to individuals between 19 and 54 years of age (Phase I), volunteers up to 80 years of age will be included. Individuals with a comorbidity or chronic disease may participate, as long as it is controlled. This is a clinical trial that is carried out randomly and totally blind, comparing the results of the vaccine candidate with the administration of placebo.
It is considered that all individuals will benefit because, once the codes are opened, those who received placebo will be vaccinated with the immunogen. If the safety and immunogenicity results are corroborated, this phase II will be evaluated in March (the trial must conclude by March 15), and it will be preparing rapidly to consider a phase III. It is found in the two doses evaluated that a high percent of individuals developed an antibody response against the SARS-CoV-2 protein, that the sera of these individuals had the ability to inhibit the binding of the receptor and that protein, and that these antibodies in addition, in a viral neutralization assay they also had functional activity.
Competing interests: No competing interests