Havana, Sep 3 (Prensa Latina) Cuba continues today the clinical trial of the vaccine candidate Soberana 01 against Covid-19, by integrating a second group of 20 volunteers between 60 and 80 years old.
Moments before the process, the persons received the relevant information following the established protocols.
The clinical trial is a study, it is an investigation made on volunteers, and this time it has two phases. In this first one, we have divided two groups, one of volunteers between 19 and 59 years old, and another one between 60 and 80 years old, according to Dr. Sonia Pérez.
Each group, in turn, will be randomly divided into three subgroups for the different doses of the research product, or for the control formula, which is the VA-MENGOC-BC vaccine, said the specialist.
Perez added that the vaccine candidate Soberana 01 is applied in two doses: the first day, which is called time zero, and then a second dose is given at 28 days. The investigation ends 28 days after the second dose is applied, that is, a total of 59 days.
The purpose of this trial is to determine if the vaccine is safe in order to extend it to a larger group of volunteer participants and then to the population, said the specialist quoted by Granma newspaper.
It is a preventive vaccine, it is a single protocol that has this first phase, where we have to measure the safety of the product. It means that everything that happens with the volunteers is recorded. If the vaccine proves to be safe, we advance in the research,’ he pointed out.
By evaluating two doses of the product, as the research progresses, the most effective and safest dose will be demonstrated, and that will be the one we will keep for later stages of clinical trials, Perez said.
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.
On August 24,” the newspaper recalls, “the vaccine was administered to 20 people between 19 and 59 years old, starting the first phase of the clinical trial.
(Taken from PL)