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September Tuesday

Second group of volunteers join SOBERANA 01 clinical trial in Cuba


HAVANA, Cuba, Sep 3 (ACN) A group of 20 Cuban volunteers recently joined the clinical trial of SOBERANA 01. They will contribute to the purpose of determining if the vaccine against COVID-19 is safe to be extended to a larger group of participants and then to the Cuban population in general.

The second group of volunteers, aged between 60-80 years old, will receive a vaccine dose on the first day, called time zero, then they will receive a second one after 28 days, and the research is closed almost three months after the application of the drug.
For the first stage of the clinical trial, the volunteers have been divided in two groups, one younger group with persons between 19-59 years old and another one from 60 - 80, each group in turn will be randomly divided in three subgroups for the different doses of the research product or for the control product, which is the VA-MENGOC-BC vaccine.
During the time of the study, four blood extractions are carried out, the first one being at time zero and the 56th day after the second dose, as well as two intermediate extractions to measure the antibody levels.
The vaccine is preventive, and in this first phase of research the safety of the product is measured, and everything that happens with the volunteers is registered; if it proves to be safe, then the study progresses.
It will also be demonstrated which is the most effective and safest dose, and that will be the one applied in the subsequent stages.
SOBERANA 01 is the 30th vaccine candidate in the world and the first in Latin America and the Caribbean to receive an authorization for clinical trials.

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